StemCell Therapy

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (NASDAQ:SGEN - News) today reported financial results for the fourth quarter and year ended December 31, 2011. The company also highlighted the ADCETRIS (brentuximab vedotin) product launch, recent ADCETRIS clinical data, ongoing and planned clinical development activities and upcoming milestones.

“We are pleased with the successful launch of ADCETRIS and our execution in bringing this drug to patients in need,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Our commercialization initiatives continue to focus on expanding awareness of ADCETRIS among oncologists, particularly in the community setting, and ensuring an efficient reimbursement process. We are also executing on a broad clinical development program of ADCETRIS to evaluate its potential in earlier lines of therapy for Hodgkin lymphoma and mature T-cell lymphomas, as well as in other CD30-positive malignancies. Over the past few months, we have reported encouraging data in multiple settings that support our aggressive clinical development plans, including in front-line Hodgkin lymphoma, front-line systemic ALCL and relapsed CTCL. In addition, we and our collaborators are advancing a robust pipeline of clinical and preclinical ADC programs.”

Recent Highlights

Reported clinical data on ADCETRIS (brentuximab vedotin) in multiple settings, notably demonstrating strong progress towards the company’s goal of redefining front-line therapy for Hodgkin lymphoma and mature T-cell lymphomas. ADCETRIS has not been approved for use in any of the following settings. Data were presented from:

A phase I trial evaluating sequential and concurrent administration of ADCETRIS with multi-agent chemotherapy in front-line mature T-cell lymphomas, including systemic anaplastic large cell lymphoma (sALCL). A phase I trial evaluating concurrent administration of ADCETRIS with multi-agent chemotherapy in front-line Hodgkin lymphoma. An investigator-sponsored phase II clinical trial of ADCETRIS in patients with cutaneous T-cell lymphoma (CTCL). Case studies of two patients with peripheral T-cell lymphoma (PTCL). A case series of patients with Hodgkin lymphoma or sALCL who received greater than 16 cycles of ADCETRIS. An analysis of the outcome of patients with relapsed Hodgkin lymphoma or sALCL who received an allogeneic stem cell transplant after treatment with ADCETRIS.

Announced multiple recent clinical trial initiations to broadly evaluate ADCETRIS in CD30-positive malignancies. Highlights include:

Initiated a phase II clinical trial in relapsed or refractory CD30-positive non-Hodgkin lymphomas, including PTCL, diffuse large B-cell lymphoma and other less common lymphoma subtypes. Initiated a phase II clinical trial in patients with CD30-positive non-lymphoma malignancies, including solid tumors, leukemia and multiple myeloma. Supported five investigator-sponsored trials (ISTs), including trials to evaluate ADCETRIS in earlier lines of Hodgkin lymphoma therapy, in older people with Hodgkin lymphoma and in other CD30-positive malignancies; expect to support multiple additional ISTs utilizing ADCETRIS to begin during 2012.

Demonstrated continued progress across product pipeline of antibody-drug conjugates (ADCs), including:

Completed enrollment in a phase I trial of single-agent SGN-75 in non-Hodgkin lymphoma and renal cell carcinoma. Completed enrollment in a phase I clinical trial of ASG-5ME for patients with pancreatic cancer; patient enrollment in a phase I clinical trial of ASG-5ME for prostate cancer is ongoing. ASG-5ME is a co-development program with Agensys, an affiliate of Astellas. Continued patient enrollment in a phase I clinical trial of ASG-22ME for solid tumors. ASG-22ME is a co-development program with Agensys, an affiliate of Agensys.

Achieved multiple milestones driven by collaborator progress under ADC agreements, including:

Preclinical milestone payments from Pfizer and Abbott. Three payments from Agensys, an affiliate of Astellas, upon exercise of options for additional exclusive antigen licenses under the companies’ ongoing ADC collaboration.

Upcoming Milestones

Planning multiple milestones for ADCETRIS and other pipeline programs, including:

Initiating a phase III clinical trial of ADCETRIS in CTCL by mid-2012. Initiating a phase III clinical trial of ADCETRIS in front-line advanced stage Hodgkin lymphoma by late 2012 to early 2013. Initiating a phase III clinical trial of ADCETRIS in front-line mature T-cell lymphomas, including sALCL, by late 2012 to early 2013. Submitting an application during the first half of 2012 to Health Canada for approval of ADCETRIS in relapsed Hodgkin lymphoma and sALCL. Millennium/Takeda expects a decision during 2012 from the European Medicines Agency (EMA) on an ADCETRIS marketing authorization application (MAA) filed by Takeda Global Research & Development Centre (Europe); the MAA filing was accepted by the EMA in June 2011. Initiating during 2012 a phase Ib clinical trial to evaluate SGN-75 in combination with everolimus, an mTOR inhibitor, for renal cell carcinoma. Submitting an investigational new drug application during 2012 for SGN-CD19A, a CD19-targeted ADC.

Fourth Quarter and Year 2011 Financial Results

Revenues in the fourth quarter of 2011 were $48.9 million, compared to $8.1 million in the fourth quarter of 2010. Fourth quarter 2011 revenues include ADCETRIS net product sales of $33.2 million. For the year 2011, revenues were $94.8 million, compared to $107.5 million for the year 2010. Revenues for the year in 2011 include $43.2 million in ADCETRIS net product sales. In addition, 2011 revenues were driven by revenue under the company’s ADCETRIS and ADC collaborations. Revenues for the year ended December 31, 2010 included approximately $70 million earned in the first half of 2010 under the dacetuzumab collaboration with Genentech that ended in June 2010.

Total costs and expenses for the fourth quarter of 2011 were $67.6 million, compared to $43.0 million for the fourth quarter of 2010. For the year 2011, total costs and expenses were $239.2 million, compared to $175.7 million for the year 2010. The planned increases in 2011 costs and expenses were primarily driven by sales and marketing activities related to the launch of ADCETRIS and higher research and development expenses, including clinical development to evaluate potential additional applications of ADCETRIS and to advance the company’s ADC pipeline programs. Under the ADCETRIS collaboration with Millennium, development costs incurred by Seattle Genetics are included in research and development expense. Joint development costs are co-funded by Millennium on a 50:50 basis. Reimbursement payments received from Millennium are recognized as revenue over the development period of the collaboration along with other development payments received, including the upfront payment and milestone payments. Non-cash, share-based compensation expense for the year 2011 was $20.0 million, compared to $14.3 million for the year 2010.

Net loss for the fourth quarter of 2011 was $27.2 million, or $0.24 per share, compared to a net loss of $34.5 million, or $0.34 per share, for the fourth quarter of 2010. Net loss in the fourth quarter of 2011 includes an $8.7 million valuation adjustment for the company’s holdings in auction rate securities, resulting in a carrying value of $5.8 million. For the year ended December 31, 2011, net loss was $152.0 million, or $1.34 per share, compared to net loss of $66.3 million, or $0.66 per share, for year ended December 31, 2010.

As of December 31, 2011, Seattle Genetics had $330.7 million in cash and investments, compared to $294.8 million as of December 31, 2010. The increase in cash and investments reflects net proceeds of approximately $168 million from the company’s public offering of common stock in February 2011 and collaboration payments received during 2011 totaling approximately $70 million.

2012 Financial Outlook

Seattle Genetics anticipates that revenues from collaboration and license agreements in 2012 will be in the range of $55 million to $65 million. These revenues will be generated from fees, milestones and reimbursements earned through the company’s ADCETRIS and ADC collaborations. The company is not providing guidance on expected revenue from ADCETRIS product sales at this time.

Total research and development and selling, general and administrative expenses in 2012 are expected to be in the range of $245 million to $270 million, approximately 35 percent of which is expected to be attributable to selling, general and administrative expenses. Operating expenses will be directed primarily towards commercialization and clinical trials of ADCETRIS, development and clinical activities for SGN-75, ASG-5ME and ASG-22ME, IND-enabling activities for SGN-CD19A, and advancing other preclinical programs. Non-cash expenses are expected to be in the range of $30 million to $33 million in 2012, primarily attributable to share-based compensation expense.

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast to discuss the financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be available from Seattle Genetics’ website at http://www.seattlegenetics.com, under the Investors and News section, or by calling (877) 941-8609 (domestic) or (480) 629-9692 (international). The access code is 4509854. A replay of the discussion will be available beginning at approximately 3:30 p.m. PT today from Seattle Genetics’ website or by calling (800) 406-7325 (domestic) or (303) 590-3030 (international), using access code 4509854. The telephone replay will be available until 4:00 p.m. PT on Wednesday, February 15, 2012.

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. ADCETRIS is approved for the treatment of patients with relapsed Hodgkin lymphoma and for the treatment of patients with relapsed sALCL.

About Seattle Genetics

Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The FDA granted accelerated approval of ADCETRIS in August 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at http://www.seattlegenetics.com.

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the company’s expectations for initiation of future clinical trials, data availability from ongoing clinical trials, expectations for additional regulatory approvals and expectations for 2012 collaboration and license revenue. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the safety and/or efficacy results of our clinical trials of ADCETRIS affect the commercial potential or ability to initiate future clinical trials of ADCETRIS. We may also be delayed in our planned trial initiations and regulatory submissions and approvals for reasons outside of our control. We may also fail to receive milestone payments under our collaborations and experience unforeseen increased expenses or unexpected reductions in revenues. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company’s 10-Q for the quarter ended September 30, 2011 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

  Seattle Genetics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)     December 31,
2011   December 31,
2010 Assets Cash, cash equivalents, short and long term investments $ 330,696 $ 294,840 Other assets   94,520   35,096 Total assets $ 425,216 $ 329,936   Liabilities and Stockholders' Equity Accounts payable and accrued liabilities $ 53,048 $ 25,783 Deferred revenue and long-term liabilities 153,319 142,635 Stockholders' equity   218,849   161,518 Total liabilities and stockholders' equity $ 425,216 $ 329,936     Seattle Genetics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)    

Three months ended
December 31,

  Twelve months ended
December 31,   2011       2010     2011       2010   Revenues Net product sales $ 33,194 $ - $ 43,241 $ - Collaboration and license agreement revenues   15,693     8,146     51,537     107,470   Total revenues   48,887     8,146     94,778     107,470   Costs and expenses Cost of sales 2,391 - 3,115 - Research and development 40,239 32,520 163,396 146,410 Selling, general and administrative   24,954     10,522     72,659     29,258   Total costs and expenses   67,584     43,042     239,170     175,668   Loss from operations (18,697 ) (34,896 ) (144,392 ) (68,198 ) Investment income (loss), net   (8,468 )   350     (7,638 )   1,933   Net loss $ (27,165 ) $ (34,546 ) $ (152,030 ) $ (66,265 )   Basic and diluted net loss per share $ (0.24 ) $ (0.34 ) $ (1.34 ) $ (0.66 )  

Weighted-average shares used in computing basic and diluted net loss per share

  115,064     101,450     113,098     101,055    

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Seattle Genetics Reports Fourth Quarter and Year 2011 Financial Results

Heart-Attack Damage Heals After Stem Cell Treatment

Feb. 13, 2012 -- A new stem cell treatment resurrects dead, scarred heart muscle damaged by a recent heart attack.

The finding, just in time for Valentine's Day, is the clearest evidence yet that literally broken hearts can heal. All that's needed is a little help from one's own heart stem cells.

"We have been trying as doctors for centuries to find a treatment that actually reverses heart injury," Eduardo Marban, MD, PhD, tells WebMD. "That is what we seem to have been able to achieve in this small number of patients. If so, this could change the nature of medicine. We could go to the root of disease and cure it instead of just work around it."

Marban, director of the Cedars-Sinai Heart Institute in Los Angeles, led the study. He invented the "cardiosphere" culture technique used to create the stem cells and founded the company developing the treatment.

It's the first completed, controlled clinical trial showing that scarred heart tissue can be repaired. Earlier work in patients with heart failure, using different stem cells or bone-marrow stem cells, also showed that the heart can regenerate itself.

"These findings suggest that this therapeutic approach is feasible and has the potential to provide a treatment strategy for cardiac regeneration after [heart attack]," write University of Hong Kong researchers Chung-Wah Siu and Hung-Fat Tse. Their editorial accompanies the Marban report in the Feb. 14 advance online issue of The Lancet.

Heart Regenerates With Stem Cell Help

The stem cells don't do what people think they do, Marban says.

It's been thought that the stem cells multiply over and over again. In time, they were supposed to be turning themselves and their daughter cells into new, working heart muscle.

But the stem cells seem to be doing something much more amazing.

"For reasons we didn't initially know, they stimulate the heart to fix itself," Marban says. "The repair is from the heart itself and not from the cells we give them."

Exactly how the stem cells do this is a matter of "feverish research" in Marban's lab.

The phase I clinical trial enrolled 25 patients who had just had a heart attack. On average, each patient had lost a quarter of his heart muscle. MRI scans showed massive scars.

Eight patients got standard care. The other 17 received increasing infusions of what Marban calls stem cells. The cells were grown in the lab from tiny amounts of heart cells taken from the patients' own hearts via biopsy. Six to 12 weeks later, the cells were infused directly back into patients' hearts.

A year later, the mass of scar tissue in the treated patients' hearts got 42% smaller. And healthy heart muscle increased by 60%. No such regeneration was seen in the patients who got standard care.

Because all of the patients were doing relatively well, there was no dramatic difference in clinical outcome. However, treated patients had a bit better exercise endurance.

"This discovery challenges the conventional wisdom that, once established, cardiac scarring is permanent and that, once lost, healthy heart muscle cannot be restored," Marban and colleagues conclude.

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Scarred Hearts Healed After Heart Attack

The damage caused by a heart attack was healed by using stem cells gathered from the patient’s own heart in a small trial written up in The Lancet journal, according to the BBC.

The preliminary study was carried out at the Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University in Baltimore, and involved 25 patients who had suffered heart attacks recently, reported The Los Angeles Times.

Seventeen of the subjects in the study were given infusions of stem cells “cultured from a raisin-sized chunk of their own heart tissue,” while the other eight were given standard care, reported The LA Times.

The size of the scars on heart tissue damaged by a heart attack decreased in size from 24 percent of the heart to 12 percent of the heart, said Dr. Eduardo Márban, the lead researcher in the study. He wrote to The LA Times in an email that the most surprising aspect of the findings was the fact that the heart could regrow healthy tissue.

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The study used a procedure invented by Márban to isolate heart stem cells from healthy tissue from each patient’s heart, and then grow millions of new cells in a petri dish, according to CNN. The patients who received the stem cell treatment either had 12 million or 25 million such cells injected back into their hearts.

Deepak Shrivastava, the director of the Gladstone Institute of Cariovascular Disease based in San Francisco, told Bloomberg, “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”

Márban told CNN, “If we can regenerate the whole heart, then the patient would be completely normal. We haven’t fulfilled that yet, but we’ve gotten rid of half the injury, and that’s a good start."

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http://www.globalpost.com/dispatch/news/health/120213/stem-cells-used-heal-heart-attack-damage

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Stem cells used to heal heart attack damage

WALKER, Mich. (WOOD) - Dogs who received the first in-clinic stem cell therapy in West Michigan returned to the vets who treated them Monday morning.

Boris and Natasha returned to Kelley's Animal Clinic for their 60-day checkup after receiving stem cell treatment in December 2011.

Dr. James Kelley and his staff of vets removed fat tissue from the dogs and activated it with an enzyme before injecting it into their back legs.

This adult animal stem cell technology is different from the controversial embryonic stem cell therapy.

Kelley said both dogs are doing amazingly well and that the procedure has done more than just help their arthritis.

"We're finding that not only the joints are affected, the rest of the animal is affected as well," said Kelley. "The skin is better. The attitude in these dogs is much improved."

Kelley and his staff have done 16 stem cell treatments since the first on Boris and Natasha, and he said all the dogs are showing signs of improvement after a short period of time.

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Dogs who got stem cell therapy are well

Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.

In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.

“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”

The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University (43935MF) in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.

“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”

Minimally Invasive

The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.

A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.

While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.

Heart Regeneration

“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”

While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.

“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.

The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Lisa Marban, is also a founder and chief executive officer.

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Scarred Hearts Can Be Mended With Novel Stem Cell Therapy, Study Finds

February 14, 2012, 12:22 AM EST

By Ryan Flinn

Feb. 14 (Bloomberg) -- Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.

In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.

“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”

The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.

“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”

Minimally Invasive

The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.

A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.

While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.

Heart Regeneration

“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”

While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.

“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.

The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Lisa Marban, is also a founder and chief executive officer.

--Editors: Angela Zimm, Andrew Pollack

-0- Feb/13/2012 22:32 GMT

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Scarred Hearts Can Be Mended With Stem Cell Therapy, Study Shows

COLUMBIA, SC (WIS) - Cutting-edge arthritis treatment for our four-legged family members is now available in Columbia.

Banks Animal Hospital is the first in the area to offer in-house Stem Cell therapy. It uses your pets own body to heal itself.

Take 13-year-old Maggie, for example. The energetic pup has a limp that usually keeps her from jumping or going up stairs.

"Today when everybody's out there filming her little limp it's not as pronounced because she wants to please," said Maggie's owner, Beth Phibbs. "She's just a great dog."

But a great attitude wasn't enough to repair a bad case of cervical spine arthritis.

So Monday, Beth brought Maggie to Banks Animal Hospital for the Stem Cell therapy. Like many, Beth had never heard of Stem Cell work in animals. "Until Dr. Banks mentioned it to me I was like, beg your pardon?"

"There's no down side, no side effects because you're using your own cells," said Dr Ken Banks.

Banks and his staff first gather some of Maggie's blood and fat. Both are good places to find the repair cells they're after. Adult stem cells, not the controversial embryonic kind, are then separated and spun down.

"The repair system in Maggie's body has failed," said Jason Richardson of MediVet-America. "It's fallen asleep at the wheel, we're taking these repair cells, activating them so a chronic condition like osteo arthritis to Maggie will now be an acute illness."

This kind of treatment used to take days with material being shipped across the country, but now it can be done in hours.

"The ability to do it same day, convenience, the ability to do it in clinic saves a lot of money to the doctor which he can then pass on to the patient," said Richardson.

The treatment will still run you around $2,000, but Richardson says that's half of what the similar treatment use to cost.

When it's over, Maggie should be able to live out her life pain and drug free -- something Phibbs is looking forward to.

"I'm hoping in a couple of weeks she's gonna have a new lease on life," said Phibbs.

Copyright 2012 WIS. All rights reserved.

Originally posted here:
Vet offers stem cell therapy for dogs

MONDAY, Feb. 13 (HealthDay News) -- Stem cell therapy's promise for healing damaged tissues may have gotten a bit closer to reality. In a small, early study, heart damage was reversed in heart-attack patients treated with their own cardiac stem cells, researchers report.

The cells, called cardiosphere-derived stem cells, regrew damaged heart muscle and reversed scarring one year later, the authors say.

Up until now, heart specialists' best tool to help minimize damage following a heart attack has been to surgically clear blocked arteries.

"In our treatment, we dissolved scar and replaced it with living heart muscle. Such 'therapeutic regeneration' has long been the holy grail of cell therapy, but had never been accomplished before; we now seem to have done it," said study author Dr. Eduardo Marban, director of the Cedars-Sinai Heart Institute in Los Angeles.

However, outside experts cautioned that the findings are preliminary and the treatment is far from ready for widespread use among heart-attack survivors.

The study, published online Feb. 14 in The Lancet, involved 25 middle-aged patients (average age 53) who had suffered a heart attack. Seventeen underwent stem cell infusions while eight received standard post-heart attack care, including medication and exercise therapy.

The stem cells were obtained using a minimally invasive procedure, according to the researchers from Cedars-Sinai and the Johns Hopkins Hospital in Baltimore.

Patients received a local anesthetic and then a catheter was threaded through a neck vein down to the heart, where a tiny portion of muscle was taken. The sample provided all the researchers needed to generate a supply of new stem cells -- 12 million to 25 million -- that were then transplanted back into the heart-attack patient during a second minimally invasive procedure.

One year after the procedure, the infusion patients' cardiac scar sizes had shrunk by about half. Scar size was reduced from 24 percent to 12 percent of the heart, the team said. In contrast, the patients receiving standard care experienced no scar shrinkage.

Initial muscle damage and healed tissue were measured using MRI scans.

After six months, four patients in the stem-cell group experienced serious adverse events compared with only one patient in the control group. At one year, two more stem-cell patients had a serious complication. However, only one such event -- a heart attack -- might have been related to the treatment, according to the study.

In a news release, Marban said that "the effects are substantial and surprisingly larger in humans than they were in animal tests."

Other experts were cautiously optimistic. Cardiac expert Dr. Bernard Gersh, a professor of medicine at Mayo Clinic, is not affiliated with the research but is familiar with the findings.

"This study demonstrates that it is safe and feasible to administer these cardiac-derived stem cells and the results are interesting and encouraging," he said.

Another specialist said that while provocative and promising, the findings remain early, phase-one research. "It's a proof-of-concept study," said interventional cardiologist Dr. Thomas Povsic, an assistant professor of medicine at the Duke Clinical Research Institute, in Durham, N.C.

And Dr. Chip Lavie, medical director of Cardiac Rehabilitation and Prevention at the John Ochsner Heart and Vascular Institute, in New Orleans, also discussed the results. He said that while the study showed that the cardiac stem cells reduced scar tissue and increased the area of live heart tissue in heart attack patients with moderately damaged overall heart tissue, it did not demonstrate a reduction in heart size or any improvement in the heart's pumping ability.

"It did not improve the ejection fraction, which is a very important measurement used to define the overall heart's pumping ability," Lavie noted. "Certainly, much larger studies of various types of heart attack patients will be needed before this even comes close to being a viable potential therapy for the large number of heart attack initial survivors."

Povsic concurred that much larger studies are needed. "The next step is showing it really helps patients in some kind of meaningful way, by either preventing death, healing them or making them feel better."

It's unclear what the cost will be, Povsic added. "What society is going to be willing to pay for this is going to be based on how much good it ends up doing. If they truly regenerate a heart and prevent a heart transplant, that would save a lot money."

Marban, who invented the stem cell treatment, said the while it would not replace bypass surgery or angioplasty, "it might be useful in treating 'irreversible' injury that may persist after those procedures."

As a rough estimate, he said that if larger, phase 2 trials were successful, the treatment might be available to the general public by about 2016.

More information

The U.S. National Heart, Lung, and Blood Institute describes current heart attack treatment.

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Stem Cell Treatment Might Reverse Heart Attack Damage

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of third patient in its Phase 1/2 trial for Stargardt’s macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient was treated on Monday (Feb. 6) by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and retina division chief at UCLA’s Jules Stein Eye Institute. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.

“With the treatment of this third Stargardt’s patient at Jules Stein Eye Institute, we have now completed the treatment of the first cohort of patients under our clinical protocol for phase I/II of our U.S. SMD trial,” said Gary Rabin, chairman and chief executive officer of ACT. “We will continue to regularly monitor the three SMD patients in this trial, and by early spring anticipate review of their progress and safety-related data by the Data and Safety Monitoring Board (DSMB). With approval of the DSMB, we would then advance to the next cohort of patients and administer a higher dosage of RPE cells. In the context of all three trials we have running, this patient is the fifth person worldwide to be treated with our hESC-derived RPE cells. To date, there have been no complications or side effects due to the RPE cells, and we remain cautiously optimistic that our ongoing clinical programs will demonstrate the safety and tolerability of ACT’s stem cell-derived RPE cells.”

Each of the three clinical trials being undertaken by the company in the U.S. and Europe will enroll 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with SMD or dry age-related macular degeneration (dry AMD) at 12 months, the study’s primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be enrolled in the Company’s U.K. clinical trial was treated at Moorfields Eye Hospital in London.

Further information about patient eligibility for the SMD study and the concurrent study on dry AMD is also available on www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 and NCT01344993.

About Stargardt's Disease

Stargardt’s disease or Stargardt’s Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2010. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company’s clinical trials will be successful.

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ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from ...

JERUSALEM--(BUSINESS WIRE)--

Gamida Cell announced today that the Gamida Cell-Teva Joint Venture (JV), equally held by Gamida Cell and Teva Pharmaceutical Industries, has enrolled the last of 100 patients in the international, multi-center, pivotal registration, Phase III clinical trial of StemEx, a cell therapy product in development as an alternative therapeutic treatment for adolescents and adults, with blood cancers such as leukemia and lymphoma, who cannot find a family related, matched bone marrow donor.

StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining, non-manipulated cells from the same unit.

Dr. Yael Margolin, president and chief executive officer of Gamida Cell, said, "The JV is planning to announce the safety and efficacy results of the Phase III StemEx trial in 2012 and to launch the product into the market in 2013. It is our hope that StemEx will provide the answer for the thousands of leukemia and lymphoma patients unable to find a matched, related bone marrow donor.”

Dr. Margolin continued, “StemEx may be the first allogeneic cell therapy to be brought to market. This is a source of pride for Gamida Cell, as it further confirms the company’s leadership as a pioneer in cell therapy. In addition to StemEx, Gamida Cell is developing a diverse pipeline of products for the treatment of cancer, hematological diseases such as sickle cell disease and thalassemia, as well as autoimmune and metabolic diseases and conditions helped by regenerative medicine.”

About Gamida Cell

Gamida Cell is a world leader in stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. The company’s pipeline of stem cell therapy products are in development to treat a wide range of conditions including blood cancers such as leukemia and lymphoma, solid tumors, non-malignant hematological diseases such as hemoglobinopathies, acute radiation syndrome, autoimmune diseases and metabolic diseases as well as conditions that can be helped by regenerative medicine. Gamida Cell’s therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, which are expanded in culture. Gamida Cell was successful in translating these proprietary expansion technologies into robust and validated manufacturing processes under GMP. Gamida Cell’s current shareholders include: Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: http://www.gamida-cell.com.

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The Gamida Cell-Teva Joint Venture Concludes Enrollment for the Phase III Study of StemEx®, a Cord Blood Stem Cell ...

TORONTO - Researchers have been given the go-ahead to test stem cells from cord blood with the ultimate goal of reversing hearing loss in infants and toddlers whose inner ears have been damaged.

U.S. regulators have approved the Phase I study, which has a primary objective of determining the safety of the experimental stem cell therapy.

The therapy involves transfusing a baby's own stem cells from umbilical cord blood, banked by parents after their child's birth. Ten children aged six weeks to 18 months old with sensorineural hearing loss will be recruited for the study by doctors at Children's Memorial Hermann Hospital in Houston.

"We're looking more at the ones that suffer an injury around birth or shortly after birth," said Dr. Samer Fakhri, a specialist in head and neck surgery and principal investigator of the study.

Fakhri, a Montreal native who received his medical training at McGill University, said such injuries to the inner ear can be caused by viral infections and even some medications.

Sensorineural hearing impairment occurs when structures in the inner ear or the nerve pathways between the inner ear and the brain are damaged. The critical structure in the inner ear is the snail-shell-shaped cochlea, which contains "hair cells" that gather electrical signals, which are transferred to the brain and perceived as sound.

A child with this kind of hearing loss can suffer significant impairment, Fakhri said from Houston. "You may hear parts of sounds. You may not hear the sounds at all, or you may hear very faint sounds.

"If they lose hearing at four weeks or five weeks due to a viral infection" — meningitis is a common cause — "we know that there is a tremendous impact," he said.

"There's a lot of research that has been done in child development that has determined that there's really a critical window for children to develop speech, language and social development, and it's probably in the first 18 months."

The idea for the trial was triggered by a 2008 study by European scientists, who infused human cord blood into laboratory mice with induced sensorineural hearing loss. An examination of the treated animals about two months later showed "inner ear organization and structure were basically restored," said Fakhri.

"That was the study that was a proof of concept ... That was such a dramatic result."

Fakhri said the exact role of the stem cells in the repair of damaged tissue in the mice isn't known, but there are a couple of theories.

Stem cells can give rise to many different types of cells in the body, so it may be they effect the repair by regenerating lost hair cells. But a more recent theory suggests that stem cells may go to the site of injury and set off the body's innate repair mechanisms.

"In that sense, they play more of a supporting role," he said.

While regenerating tissues is the great hope of stem cells — and they do appear to hold a lot of promise — the idea that they could restore damaged hearing in humans is still speculative, doctors say.

"This study is really very, very preliminary," said Dr. Robert Harrison, a professor of head and neck surgery at the University of Toronto.

"That's the safety issue," he said, stressing that the FDA-approved study must first ensure the stem cells do no harm to patients. Figuring out if they actually work to repair the organ of hearing would have to be proven in subsequent trials.

"We're a long way from looking at the possible therapeutic value of this in terms of restoring some sort of hearing," said Harrison, a senior scientist at the Hospital for Sick Children and a director of the Hearing Foundation of Canada.

"It's a very theoretical concept, and in my opinion it's not going to happen soon."

Current treatment of sensorineural hearing loss in young children is pretty well restricted to hearing aids or cochlear implants, surgically implanted electronic devices, Fakhri said. Both are used to amplify any residual hearing.

The rest is here:
Study looks at whether stem cells in cord blood might repair hearing loss in kids

Dick Monfort. (Karl Gehring | The Denver Post)

Over the next few months, nine men will decide which projects get funding under a state law created in 2009 to bring new visitors to Colorado.

They are the members of the Colorado Economic Development Commission, which approves loans and grants from the state's economic-development fund to help businesses expand and to attract new companies to Colorado.

Now they are responsible for determining which two projects, if any, are eligible to receive up to a combined $50 million a year in state sales-tax rebates.

Five commission members are appointed by the governor, two by the president of the Senate and two by the speaker of the House. They come from across the state and represent a variety of industries, including banking, real estate and law.

"The commission has good representation statewide," said member Dwayne Romero. "It's not just a Denver-centric composition. That's going to give a broader perspective and will help to enliven the conversation and discussion that will occur leading up to the recommendations."

The applicants for the incentives include Aurora, for a proposed 1,500-room hotel and conference center; Douglas County, for a prehistoric-archaeology museum and sports complex; Glendale, for an outdoor riverwalk entertainment complex; Pueblo, for a downtown riverwalk area that would include a bull-riding training center and an expanded convention center; Estes Park, to redevelop and renovate Elkhorn Lodge and build a 50-acre, year-round adventure park; and Montrose County, which is proposing 141 tourism and commercial projects.

Here's who will decide which projects, if any, receive the Regional Tourism Act incentives:

Dick Monfort - Chairman

Since Monfort took control of the Colorado Rockies in 2005, the ballclub's attendance has increased 50 percent and revenue has risen every year. Before taking over the Rockies, the Greeley businessman spent 25 years in the cattle business.

Monfort also owns the Hyatt Grand Champions Hotel in Palm Springs, Calif., and Hilltop Steak House in Boston. He helped launch the Montera Cattle Co. in 1996 and, a year later, the first Brett Favre Steak House in Milwaukee.

Don Elliman

Colorado's former economic-development chief is now executive director of the Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology. Now, he'll also serve as interim chancellor of the University of Colorado Denver and Anschutz Medical Campus.

Elliman's career has covered a broad spectrum. He was publisher of Sports Illustrated and People, president of Kroenke Sports Enterprises and chairman of the board of Children's Hospital Colorado.

Howard Gelt

As an attorney with Polsinelli Shugart specializing in commercial real estate, Gelt represents landlords and tenants in lease transactions, property management, listing agreements and tenant-improvement contracts.

Gelt serves on the boards of the Metropolitan Denver Economic Development Corp., the North Metro Denver Chamber of Commerce, Coloradans for Smart Transit and the Morgan's Subdivision Historic District Association.

Dick Robinson

Robinson and his brother Eddie formed Robinson Dairy in 1975, when they bought the assets of Roberts Dairy. They sold the company to Dean Foods in 1999 but still serve as co-chief executives.

A fourth-generation Denver native, Dick Robinson was commissioned a second lieutenant in the U.S. Army and served on active duty in the field artillery for two years. He serves on the boards of the Denver Art Museum, HCA-HealthONE and Regis University.

Wellington Webb

Webb served three terms as Denver's mayor from 1991 to 2003.

During his tenure, Denver International Airport opened; people began moving back to downtown Denver; and the Central Platte Valley was redeveloped, with Coors Field, the Pepsi Center, Elitch Gardens and a new Broncos stadium. He also persuaded voters to approve a $300 million expansion to the Colorado Convention Center, which opened in December 2004, and led tough, successful negotiations for a nearby hotel.

He founded Webb Group International in October 2003 .

Dwayne Romero

Romero, a Snowmass real estate developer, served a brief stint as executive director of the Colorado Office of Economic Development and International Trade.

He is president of Related Snowmass, a division of New York development and investment firm Related Cos., and manages a portfolio of commercial and lodging properties in Snowmass Village.

He is on the boards of the Aspen Historical Society and the Aspen Rotary Club.

Bill Sisson

A Grand Junction resident, Sisson retired at the end of 2009 from his position as senior regional president at American National Bank and director of Sturm Financial Group.

After serving in the U.S. Army, Sisson graduated with a finance degree from the University of Denver. Sisson is former chairman of the state Economic Development Commission and a member of the Government Affairs Committee of the Colorado Bankers Association.

Darius Allen

Allen was appointed to the Economic Development Commission last year, the first person from southern Colorado to serve on the panel since 2003. Allen has served four terms as a county commissioner, ranches and owns an insurance company.

J.J. Ament

Investment banker Ament gave up his post at Citigroup in 2009 for an unsuccessful run at the Republican nomination for state treasurer.

Born and raised on his family's ranch in Logan County, one of Ament's first jobs was representing farmers as executive director of the Colorado Association of Wheat Growers.

The Littleton resident currently is director of public finance at RBC Capital Markets.

Margaret Jackson: 303-954-1473 or mjackson@denverpost.com

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Colorado panel tasked with weighing eco-devo projects, doling out incentives

Dan Gross/The Gazette While working for the Washington Redskins, ?I learned a lot about the management of a large team and a large budget,? says Marty Zug, CFO of Sequella in Rockville.

With career stops that included Russia and the Washington Redskins, it took Marty Zug a while to land at Rockville biotech Sequella.

But he has remained there for more than seven years, his longest stint with one employer by far.

Carol A. Nacy, CEO and chairwoman of Sequella, for one, is happy about that.

Zug, CFO at the biotech that is developing drugs to combat infectious diseases such as tuberculosis and bacteria such as Helicobacter pylori, has become a force in lobbying for industry issues such as more funding for the state?s biotech investment tax credit program. That program has helped infuse Sequella and other biotechs with millions of dollars in much-needed capital.

?He?s been a huge addition to our company,? said Nacy, who co-founded Sequella with Chief Scientific Officer Leo Einck in 1997. ?He?s delightful to work with, smart, industrious. I?d like to clone him.?

Many CFOs can almost be exclusively number-crunchers. Not Zug. He makes friends easily and is not the kind of lobbyist who forcefully hammers home points, colleagues say.

?He really enjoys other people,? Nacy said. ?He gets along with legislators and other people in the biotech community. ... In Annapolis, he takes the time to explain the problem in clear terms.?

Steel roots

Zug grew up in Bethlehem, Pa., where his grandfather and uncle worked in the steel mills. At Lehigh University, he majored in economics and Russian studies, graduating summa cum laude. He spent his junior year studying in Moscow at the Russian Academy of Economics and became fluent in Russian.

?I took a trip there in 1987 when glasnost was one of the buzzwords,? said Zug, 42. ?I became fascinated with the country and the changes going on. I had always been interested in world affairs.?

After graduating in 1992, he moved to Russia without having a firm job offer.

?It wasn?t hard to find a job,? Zug said.

He ended up working as a project manager for Sea-Land CIS Logistics in Moscow and then as an investment officer with International Finance Corp., which has offices in Washington, D.C., and Moscow. With the latter company, Zug said, he structured and closed financing for deals worth more than $39 million in equity and $75 million in debt, and was part of the banking team that closed the first syndicated loan in Russia and the largest private financing of a Russian company in 1995.

He left International Finance in 1996 to earn a master?s of business administration at Dartmouth College in Hanover, N.H., graduating as an Edward Tuck Scholar in the top 15 percent of his class. Then came stints with Arthur Andersen in Washington, Snyder Communications in Bethesda and the Redskins.

As director of financial projects at Snyder Communications, Zug managed Wall Street corporate presentations, among other duties. The marketing firm was run by current Redskins owner Daniel M. Snyder of Potomac; it was sold to French advertising group Havas for more than $2 billion in 2000.

As a vice president with the Redskins for two years, Zug supervised a staff of 20 with a budget of more than $3 million, running the ticket office, as well as premium seating and stadium business.

?I learned a lot about the management of a large team and a large budget,? Zug said. ?I already was fairly strong in finance but got more exposure in sales and marketing.?

He then took a year off to help raise a newborn, working as an independent consultant on projects that included a $6.5 million sale of a Bahamian hotel. He also managed the Washington area?s bid for the 2008 Super Bowl. The NFL championship game typically is played in a warm-weather city or one with a domed stadium, but the local bid was strong enough to make Washington a finalist, with the game ending up in Arizona.

Russian pays off at Sequella

With Sequella, knowing Russian and having done business in that country paid dividends when Zug last year negotiated an out-license agreement with a Russian venture fund to develop a treatment for tuberculosis in the Russian Federation and neighboring countries. That agreement could be worth as much as $50 million.

Sequella?s lead drug, SQ109, targets tuberculosis and multidrug-resistant tuberculosis. The company also has significant activity working with Helicobacter pylori, which causes gastric ulcers and can help cause gastric cancer. Sequella is starting a phase 2a clinical trial for SQ109 in H. pylori at sites in Texas.

Zug, a member of the Tech Council of Maryland?s Government Relations Committee, has been a leader in growing the state?s biotech investment tax credit program, which has been run by the Department of Business and Economic Development since 2006. The program allows investors in qualifying companies to claim credits against state income taxes, while biotechs try to leverage the capital for more investment.

One of the tech council?s goals is to persuade lawmakers to increase the fund from $8 million annually, Zug said. The credits usually run out within the first hour or so that the program takes effect each July 1.

?We want to make sure this program remains a shining star and an example for other states? Zug said. ?It?s a great market-driven program that works.?

Other states, including Virginia, have implemented similar programs, he said. Last year, Rep. Christopher Van Hollen Jr. (D-Dist. 8) of Kensington sponsored the Innovative Technologies Investment Incentive Act, modeled on the Maryland tax credit program that would have allowed an investor in a biotech or high-tech company with fewer than 500 employees to claim a federal tax credit of 25 percent. But the legislation attracted only seven co-sponsors, including only one from Maryland, Rep. C.A. Dutch Ruppersberger (D-Dist. 2) of Cockeysville, and did not pass.

Besides lobbying for more tax credit funds in this year?s legislative session, which started in January and runs through April 9, Zug supports bills filed in both the House and Senate that would require that at least one-third of grants or loans awarded each year by the state?s Stem Cell Research Fund be awarded to for-profit companies with headquarters in Maryland. Most stem cell awards now go to either Johns Hopkins University or the University of Maryland, Baltimore, although in fiscal 2011, about 28 percent of awards went to collaborations with for-profit companies, including some in other states, according to a state legislative report.

Much of the success of the state?s biotech community?s efforts in Annapolis can be attributed to Zug, said Brian Levine, vice president of government relations with the tech council in Rockville, who has worked closely with him.

?He is a good leader, very organized and always provides thoughtful ideas,? Levine said.

As venture capital has dried up, programs such as the tax credit have become that much more important to growing biotechs, Zug said. Biotechs are fortunate to have the support that Maryland and entities such as the National Institutes of Health lend, he said. Sequella usually submits about eight grant applications per year to NIH, which funds two or three, Zug said.

?You will be hard-pressed to find another state doing as much as Maryland,? he said.

Marty Zug

Age: 42.

Position: CFO, Sequella, Rockville.

Previous position: Vice president, Washington Redskins.

Education: Master?s of business administration, Dartmouth College, Edward Tuck Scholar; bachelor?s in finance and Russian studies, Lehigh University.

Residence: McLean, Va.

Family: Wife, Becky, and three children.

Hobbies: Travel, family activities.

kshay@gazette.net

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Gazette.Net: From Russia and the Redskins to fighting TB in Rockville

Published: Feb. 11, 2012 at 1:56 AM

TORONTO, Feb. 11 (UPI) -- Increasing numbers of Canadians are traveling to countries for stem cell treatments that are expensive and unproven, which may be risky, researchers said.

Dominique McMahon, a postdoctoral fellow at the Dalla Lana School of Public Health at the University of Toronto, said stem cell treatments are being marketed via the Internet in China, India, Mexico, Panama, Thailand and Ukraine. In China alone, there are more than 200 hospitals offering stem cell therapies.

One Canadian couple traveled to Shenyang, China, in 2007 for multiple system atrophy. For $30,000, along with travel and living expenses for her and husband, the woman received four weeks of treatment consisting of six stem cell injections as well as acupuncture and physiotherapy five to six times per week.

The facility offers to arrange treatment for a wide variety of conditions, including ataxia, brain injury, cerebral palsy, diabetic foot disease, lower limb ischemia, multiple sclerosis, muscular dystrophy, spinal cord injury and optic nerve damage, McMahon said.

The Stem Cell Network said stem cells are used effectively in Canada only for bone marrow transplants, skin grafting and treating blood diseases, McMahon added.

"In some cases, it is not clear what is being injected," McMahon said in a statement. "Some facilities use a patient's own stem cells, while others use embryonic or fetal cells, which can create a risk of rejection. There's no proof of safety and efficacy. The quality of facilities varies. The protocols are poorly documented and not available to the patients. Even in the best-case scenarios, the doctor doesn't know whether it's safe or efficacious because of a lack of data."

The findings were published in the Canadian Medical Association Journal.

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Stem cell tourism can be pricey and risky

Similarities between genetic signatures in developing organs and breast cancer could predict and personalize cancer therapies

Newswise — La Jolla, CA---- Reviving a theory first proposed in the late 1800s that the development of organs in the normal embryo and the development of cancers are related, scientists at the Salk Institute for Biological Studies have studied organ development in mice to unravel how breast cancers, and perhaps other cancers, develop in people. Their findings provide new ways to predict and personalize the diagnosis and treatment of cancer.

In a paper published February 3 in Cell Stem Cell, the scientists report striking similarities between genetic signatures found in certain types of human breast cancer and those of stem cells in breast tissue in mouse embryos. These findings suggest that cancer cells subvert key genetic programs that guide immature cells to build organs during normal growth.

"Stem cells in a healthy developing embryo have a GPS system to alert them about their position in the organ," says Geoffrey Wahl, a professor in Salk's Gene Expression Laboratory, who led the research. "The system depends on internal instructions and external signals from the environment to tell the stem cell what to do and where to go in the body. It stimulates the stem cells to grow and form more stem cells, or to change into different cells that form complex organs, such as the breast. Our findings tell us that this GPS system is broken during cancer development, and that may explain why we detect stem-like cells in breast cancers."

The relationship between cancer and embryonic tissues was first proposed in the 1870s by Francesco Durante and Julius Cohnheim, who thought that cancers originated from cells in adults that persist in an immature, embryonic-like state. More recently, scientists including Benjamin Spike, a co-first author on the current work and post-doctoral fellow in the Wahl lab, have discovered that tumors often contain cells with stem cell characteristics revealed by their genetic signatures.

As a result, many scientists and physicians are pursuing ways to destroy stem-like cells in cancer, since such cells may make cancer more resistant to treatment and may lead to cancer recurrence. The Salk scientists are now characterizing the stem-like cells in certain forms of breast cancer to arrest their growth.

Studying the genetic activity of organ-specific stem cells is very difficult because the cells are very rare, and it is hard to separate them from other cells in the organ. But, by focusing on tissue obtained from mouse embryos, the Salk researchers were able for the first time to identify and isolate a sufficiently large number of fetal breast stem cells to begin to understand how their GPS works.

The Salk scientists first made the surprising finding that these fetal breast stem cells were not fully functional until just prior to birth. This observation suggested that a very special landscape is needed for a cell to become a stem cell. The breast stem cells at this late embryonic stage were sufficiently abundant to simplify their isolation. This enabled their genetic signature to be determined, and then compared to that of the stem-like cells in breast cancers.

The signatures of the breast stem cells in the fetus were stunningly similar to the stem-like cells found in aggressive breast cancers, including a significant fraction of a virulent cancer subtype known as "triple-negative." This is important as this type of breast cancer has until now lacked the molecular targets useful for designing personalized therapeutic strategies.

"The cells that fuel the development of tumors in the adult are unlikely to 'invent' entirely new patterns of gene expression," says Benjamin Spike. "Instead, some cancer cells seem to reactivate and corrupt programs that govern fetal tissue stem cell function, including programs from their neighboring cells that constitute the surrounding fetal stem cell landscape, or microenvironment."

The discovery of the shared genetic signatures provides a new avenue for scientists to explore the links between development and cancer. By uncovering new biological markers, the scientists hope to develop tests that individualize treatment by showing how the GPS system of a tumor operates. This should help doctors to determine which patients may benefit from treatment, and the correct types of treatment to administer.

Doctors are already using drugs, such as Herceptin, that specifically target malfunctioning genetic pathways in tumors, but no such therapies are currently available for certain aggressive forms of the disease, such as the triple negative subtype.

Although triple negative cancer cells lack the three critical genetic markers that are currently used to guide breast cancer treatment, the scientists' analysis suggests a strong reliance on signaling through pathways similar to those that affect fetal breast stem cell growth.

They found that the fetal breast stem cells are sensitive to a class of targeted therapies that already exists, so these therapies might also work in triple negative breast cancers. Laboratory studies and clinical trials are currently underway to test this possibility.

"Substantial effort is being expended to personalize cancer treatment by gaining a better understanding of the genetics of an individual patient's cancer," Wahl says. "Our findings offer a way to discover new targets and new drugs for humans by studying the primitive stem cells in a mouse."

In addition to Spike, Dannielle Engle and Jennifer Lin, both postdoctoral researchers in Wahl's laboratory, were also co-first authors on the paper.

The research was sponsored by the Breast Cancer Research Foundation, the U.S. Department of Defense, the G. Harold & Leila Y. Mathers Foundation and Susan G. Komen for the Cure.
About the Salk Institute for Biological Studies:
The Salk Institute for Biological Studies is one of the world's preeminent basic research institutions, where internationally renowned faculty probe fundamental life science questions in a unique, collaborative, and creative environment. Focused both on discovery and on mentoring future generations of researchers, Salk scientists make groundbreaking contributions to our understanding of cancer, aging, Alzheimer's, diabetes and infectious diseases by studying neuroscience, genetics, cell and plant biology, and related disciplines.

Faculty achievements have been recognized with numerous honors, including Nobel Prizes and memberships in the National Academy of Sciences. Founded in 1960 by polio vaccine pioneer Jonas Salk, M.D., the Institute is an independent nonprofit organization and architectural landmark.

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Salk Scientists Use an Old Theory to Discover New Targets in the Fight Against Breast Cancer

ScienceDaily (Feb. 7, 2012) — Reviving a theory first proposed in the late 1800s that the development of organs in the normal embryo and the development of cancers are related, scientists at the Salk Institute for Biological Studies have studied organ development in mice to unravel how breast cancers, and perhaps other cancers, develop in people. Their findings provide new ways to predict and personalize the diagnosis and treatment of cancer.

In a paper published February 3 in Cell Stem Cell, the scientists report striking similarities between genetic signatures found in certain types of human breast cancer and those of stem cells in breast tissue in mouse embryos. These findings suggest that cancer cells subvert key genetic programs that guide immature cells to build organs during normal growth.

"Stem cells in a healthy developing embryo have a GPS system to alert them about their position in the organ," says Geoffrey Wahl, a professor in Salk's Gene Expression Laboratory, who led the research. "The system depends on internal instructions and external signals from the environment to tell the stem cell what to do and where to go in the body. It stimulates the stem cells to grow and form more stem cells, or to change into different cells that form complex organs, such as the breast. Our findings tell us that this GPS system is broken during cancer development, and that may explain why we detect stem-like cells in breast cancers."

The relationship between cancer and embryonic tissues was first proposed in the 1870s by Francesco Durante and Julius Cohnheim, who thought that cancers originated from cells in adults that persist in an immature, embryonic-like state. More recently, scientists including Benjamin Spike, a co-first author on the current work and post-doctoral fellow in the Wahl lab, have discovered that tumors often contain cells with stem cell characteristics revealed by their genetic signatures.

As a result, many scientists and physicians are pursuing ways to destroy stem-like cells in cancer, since such cells may make cancer more resistant to treatment and may lead to cancer recurrence. The Salk scientists are now characterizing the stem-like cells in certain forms of breast cancer to arrest their growth.

Studying the genetic activity of organ-specific stem cells is very difficult because the cells are very rare, and it is hard to separate them from other cells in the organ. But, by focusing on tissue obtained from mouse embryos, the Salk researchers were able for the first time to identify and isolate a sufficiently large number of fetal breast stem cells to begin to understand how their GPS works.

The Salk scientists first made the surprising finding that these fetal breast stem cells were not fully functional until just prior to birth. This observation suggested that a very special landscape is needed for a cell to become a stem cell. The breast stem cells at this late embryonic stage were sufficiently abundant to simplify their isolation. This enabled their genetic signature to be determined, and then compared to that of the stem-like cells in breast cancers.

The signatures of the breast stem cells in the fetus were stunningly similar to the stem-like cells found in aggressive breast cancers, including a significant fraction of a virulent cancer subtype known as "triple-negative." This is important as this type of breast cancer has until now lacked the molecular targets useful for designing personalized therapeutic strategies.

"The cells that fuel the development of tumors in the adult are unlikely to 'invent' entirely new patterns of gene expression," says Benjamin Spike. "Instead, some cancer cells seem to reactivate and corrupt programs that govern fetal tissue stem cell function, including programs from their neighboring cells that constitute the surrounding fetal stem cell landscape, or microenvironment."

The discovery of the shared genetic signatures provides a new avenue for scientists to explore the links between development and cancer. By uncovering new biological markers, the scientists hope to develop tests that individualize treatment by showing how the GPS system of a tumor operates. This should help doctors to determine which patients may benefit from treatment, and the correct types of treatment to administer.

Doctors are already using drugs, such as Herceptin, that specifically target malfunctioning genetic pathways in tumors, but no such therapies are currently available for certain aggressive forms of the disease, such as the triple negative subtype.

Although triple negative cancer cells lack the three critical genetic markers that are currently used to guide breast cancer treatment, the scientists' analysis suggests a strong reliance on signaling through pathways similar to those that affect fetal breast stem cell growth.

They found that the fetal breast stem cells are sensitive to a class of targeted therapies that already exists, so these therapies might also work in triple negative breast cancers. Laboratory studies and clinical trials are currently underway to test this possibility.

"Substantial effort is being expended to personalize cancer treatment by gaining a better understanding of the genetics of an individual patient's cancer," Wahl says. "Our findings offer a way to discover new targets and new drugs for humans by studying the primitive stem cells in a mouse."

In addition to Spike, Dannielle Engle and Jennifer Lin, both postdoctoral researchers in Wahl's laboratory, were also co-first authors on the paper.

The research was sponsored by the Breast Cancer Research Foundation, the U.S. Department of Defense, the G. Harold & Leila Y. Mathers Foundation and Susan G. Komen for the Cure.

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The above story is reprinted from materials provided by Salk Institute for Biological Studies, via Newswise.

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Journal Reference:

Benjamin T. Spike, Dannielle D. Engle, Jennifer C. Lin, Samantha K. Cheung, Justin La, Geoffrey M. Wahl. A Mammary Stem Cell Population Identified and Characterized in Late Embryogenesis Reveals Similarities to Human Breast Cancer. Cell Stem Cell, 2012; 10 (2): 183 DOI: 10.1016/j.stem.2011.12.018

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

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Scientists use old theory to discover new targets in fight against breast cancer

WASHINGTON -- U.S. researchers have begun a groundbreaking trial to test the potential of umbilical cord blood transplants, a kind of stem cell therapy, to treat and possibly reverse hearing loss in infants.

The phase I trial follows promising studies on mice showing that such transplants were able to rebuild the structures of the inner ear, and some anecdotal evidence from humans, sparking hope of a cure for some forms of deafness.

One of those people is two-year-old Finn McGrath, who suffered brain damage after being deprived of oxygen during a prolonged and complicated delivery, according to his mother, Laura.

"His doctors told us he was at high risk for cerebral palsy, vision issues, hearing problems and mental retardation," she said in an interview with AFP.

Finn’s early days were an all-out struggle to survive, so for his parents, learning that he had failed his hearing tests and had damaged hair cells — the sensory receptors in the inner ear that pick up sounds — was almost an afterthought.

He had organ failure, breathing problems, and his cerebral palsy left him unable to roll, crawl or walk, hold his head up, talk or eat.

As his parents searched for ways to help him, they came upon stories online that told of studies using cord blood to help children with cerebral palsy and other disorders.

Prior to his birth, the McGraths had arranged to privately bank his umbilical cord blood, a procedure that costs around $2,000 plus storage fees, and remains controversial among pediatricians.

Private companies such as the Cord Blood Registry, which is funding the Texas study on hearing loss, urge expecting parents to bank their umbilical cord blood and reserve it for personal use as a way to protect their family.

That advice runs counter to the guidelines issues by the American Academy of Pediatrics in 2007, which calls such claims "unsubstantiated" and says banking for personal or family use "should be discouraged" but is "encouraged" if it is to be stored in a bank for public use.

Since Finn’s parents had already banked his, they enrolled him in cord blood trial for cerebral palsy in North Carolina and he received his first transplant in November 2009 when he was about seven weeks old.

A second transfusion followed and by May, his parents began to notice a change.

Nighttime noises, like an alarm on his food pump or the sound of ripping medical tape, would suddenly startle him awake, his mother recalled.

"He started vocalizing sounds and we could tell that he was anticipating things that we would say. Like, if he had heard a story a number of times or a song, he would smile like he recognized the song or the story."

Finn had a third infusion in September 2010, when he was one year old. Four months later, an otoacoustic emissions test (OAE), which plays a sound and picks up vibrations in the cochlea and hair cells, came back normal.

The early hearing tests that showed hearing loss were not exactly the same as the later tests that came back normal, so McGrath is cautious about comparing them directly, but she believes the cord blood transfusions may have helped.

"All I can tell you is anecdotally he was not able to hear for probably the first three or four months of his life, and then when he was about six to eight months old, he started hearing."

The hearing trial in Texas aims to take a first step in testing the safety, and later the efficacy, of transfusing cord blood in children age six weeks to 18 months who have sustained post-birth sensorineural hearing loss.

Some reasons that children lose their hearing at or after birth may include oxygen deprivation, head injury, infection, strong doses of antibiotics or loud noises.

Sensorineural hearing loss affects approximately six per 1,000 children, and there is no available medical treatment. Hearing aids or cochlear implants are typically offered to boost the ability of the damaged tissues.

"Stem cell therapy may potentially repair the damaged structures of the inner ear and restore normal hearing," lead investigator Samer Fakhri told AFP.

"We are at the initial stages of this process and the results are looking promising," Fakhri added.

Research using stem cells in cord blood, known as hematopoietic cells, is already under way on some types of brain injury, cerebral palsy, juvenile diabetes, kidney and lung disease, he said.

The new study at Memorial Hermann-Texas Medical Center is being funded by the Cord Blood Registry, and those eligible must have already banked their own umbilical cord blood with CBR.

But to Stephen Epstein, an otolaryngologist in Maryland, that does not pose a conflict of interest, because separate medical institutions in Texas and Georgia are conducting the Food and Drug Administration-approved research.

"If both of them can reproduce the same results then I would say it has some validity to it," said Epstein, who is not involved in the study.

"This is certainly a welcome, acceptable experiment, but it should be looked at with caution and time will tell."

One patient is already enrolled and the study, which runs for one year, has room for nine more.

While Finn McGrath still faces many challenges due to his cerebral palsy, his mother is grateful for the things he can do.

"I don’t know how much worse off he would have been without the stem cell transfusion," McGrath said, pointing to his normal cognition, lack of seizures, good hearing and vision.

"We remain hopeful that he will continue to improve."

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U.S. begins stem cell trial for hearing loss

Public release date: 10-Feb-2012
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Contact: Vicki Bendure
vicki@bendurepr.com
202-374-9259
Society for Maternal-Fetal Medicine

DALLAS (February 10, 2012) ? In a study to be presented today at the Society for Maternal-Fetal Medicine's annual meeting, The Pregnancy Meeting ?, in Dallas, Texas, researchers will report that early transplantation of human placenta-derived mesenchymal stem cells into the lateral ventricles of neonatal rats with birth-related brain damage is possible, and that the donor cells can survive and migrate in the recipient's brain. The study was designed to have the rat's brain damage mimic brain injury in infants with very low birth weight.

One of the major causes of neonatal brain damage is preterm delivery. Despite enormous efforts to prevent it, brain injury accounts for a major part of the clinical problems experienced by survivors of premature birth. The enormity of this problem is indicated by the occurrence of: cognitive, behavioral, attention related and/or socialization deficits in twenty-five to fifty percent of cases in this group; and major motor deficits in five to ten percent of cases in this group.

The majority of neonatal encephalopathy cases are found in infants with a very low birth weight, and include both hypoxia-ischemia and inflammation, a double-hit. Approximately 63,000 infants are born in the United States with a very low birth weight (one to five percent of all live births). In order to understand the effect of such a double-hit insult in very premature infants, this study, Early Intracranial Mesenchymal Stem Cell Therapy After a Perinatal Rat Brain Damage, was undertaken to investigate the neuroprotective effects of mesenchymal stem cells therapy on postnatal rats, whose injury was designed to mimic brain injury in infants with a very low birth weight.

"Stem cells are a promising source for transplant after a brain injury because they have the ability to divide throughout life and grow into any one of the body's more than 200 cell types, which can contribute to the ability to renew and repair tissues," said Martin M?ller, MD, with the University of Bern, Obstetrics and Gynecology, Bern, Switzerland, and one of the study's authors. "In our study, the donor cells survived, homed and migrated in the recipient brains and neurologic improvement was detected."

Assessment of the post-experiment brain damage indicated a neuroprotective effect of mesenchymal stem cell transplantation and a combination of mesenchymal stem cell and erythropoietin (a modulator substance the subjects received on postnatal days six, seven and eight) therapy.

In addition to M?ller, the study was conducted by Andreina Schoeberlein, Ursula Reinhart, Ruth Sager and Marianne Messerli, University of Bern, Obstetrics and Gynecology, Bern, Switzerland; and Daniel Surbek, University Hospital of Bern, Obstetrics and Gynecology, Bern, Switzerland.

###

A copy of the abstract is available at http://www.smfmnewsroom.org/annual-meeting/2011-meeting-abstracts/. For interviews please contact Vicki Bendure at Vicki@bendurepr.com, 540-687-3360 (office) or 202-374-9259 (cell), or Jacqueline Boggess at jacqueline@bendurepr.com, 540-687-5399 (office) or 202-738-3054 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine. The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed. For more information, visit http://www.smfm.org or http://www.facebook.com/SocietyforMaternalFetalMedicine.

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Neurologic improvement detected in rats receiving stem cell transplant

RED BANK, NJ--(Marketwire -02/08/12)- American CryoStem Corporation (OTCQB: CRYO.OB - News), a commercial developer, manufacturer and marketer of clinical products and services involving adipose tissue and adipose derived adult stem cells, announced its association with the Alliance for Regenerative Medicine (ARM).

ARM is a Washington, DC-based non-profit organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine. American CryoStem's decision to join ARM was based on the alignment of its ongoing mission to offer the highest quality products and services to help accelerate the regenerative medicine industry and ARM's support of policy efforts toward safe and reliable cellular products.

Morrie Ruffin, Managing Director for the Alliance for Regenerative Medicine, commented, "We are delighted to have American CryoStem as part of the Alliance and look forward to working together to advance the field of adipose-derived stem cells for a variety of therapeutic applications."

ARM's membership is diverse, representing leading regenerative medicine companies and investors, university-based and non-profit research institutions, patient advocacy groups, pharmaceutical companies engaged in regenerative medicine research and other organizations supporting regenerative medicine. American CryoStem has created and commercialized core proprietary products and platforms for processing, storing and quality management of adipose tissue and adipose derived adult stem cells that are broadly relevant to ARM's membership.

"American CryoStem is committed to working with industry organizations to develop cutting edge adipose tissue based treatments and therapies. One unique component of our clinical laboratory product and service suite is offering individuals the opportunity to cryogenically store their younger, healthier adult stem cells for their own future use in regenerative medicine," stated John Arnone, American CryoStem CEO. "We are pleased and honored to work with the Alliance for Regenerative Medicine to educate the public and regulators on the safe uses of adult stem cells and their potential life changing applications."

In support of these goals, the Company recently launched ACS Laboratories, thus expanding its clinical processing technology to companies, institutions and medical professionals. ACS Laboratories offers a wide range of adipose tissue specific services. Through ACS laboratories patented ACSelerate™ cell culture media, a ten product suite, American CryoStem can leverage its technology and products to participate in a broad range of clinical application opportunities.

About American CryoStem: American CryoStem Corporation (OTCQB: CRYO.OB - News) markets clinical processing products and services for adipose (fat) tissue and adipose derived adult stem cells. CRYO's clinical processing and preservation platform supports the science and applications being discovered globally by providing the highest quality, clinically processed cells and assuring their sterility, viability and growth cap abilities, while at the same time developing cutting edge application, therapies and laboratory products and services for consumers and physicians.

The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain of the statements contained herein, which are not historical facts, are forward-looking statements with respect to events, the occurrence of which involve risks and uncertainties. These forward-looking statements may be impacted, either positively or negatively, by various factors. Information concerning potential factors that could affect the Company is detailed from time to time in the Company's reports filed with the Securities and Exchange Commission.

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American CryoStem Joins Alliance for Regenerative Medicine

THERE'S a dentist in London who has a picture of Mickey Mouse on the ceiling above where his patients recline.

Long before the drilling started, this was supposed to make children more at ease.

All it did for me was to instil a profound fear of cartoon rodents. And I was in my forties.

Why, I wondered — as Mickey leered down and a grinding vibration reverberated from jaw to spine — can't we simply regrow teeth? After all, we do it in childhood, when the tooth fairy swaps our baby teeth for small coins and adult choppers.

Good news: we very nearly can. Last week, in the Journal of Biological Chemistry, a team from Tokyo, including Professor Satoshi Fukumoto, said they had created cells that could make enamel, the hard outer coating of teeth.

This follows the development of a technique by Dr Jeremy Mao at Columbia University in New York City for encouraging stem cells to move to a scaffolding where they will grow to replace a missing tooth.

"In the future," says Dr Paul Sharpe of King's College London, who has also grown teeth from tooth buds, "we envision a patient who loses a tooth and wants a replacement will be able to choose between current methods and a biological-based implant — a new natural tooth."

All these attempts involve stem cells, first discovered by Canadians James Till and Ernest McCulloch in 1963.

The body's cells all have the same DNA, but depending on the tissue that they belong to — blood, skin or kidney etc — they will have different sets of genes turned on or off. And they pass those characteristics on to their descendants. When a muscle cell divides, its two daughter cells are both muscle.

Stem cells, however, have not decided which tissue they will be. When they divide, their daughters can be either stem cells or any kind of tissue cell.

In the past decade, stem cells have sparked a revolution in biosciences, creating a whole new field called regenerative medicine as scientists learn how to grow spare human parts. While teeth may well be the first, they won't be the last.

Regenerative medicine will address two huge problems faced by transplants. The first is that potential recipients far outnumber donors. Some authorities have tried to solve this by requiring that people actively opt out of organ transplant schemes. If you're in a coma and not expected to wake up, doctors presume they can "harvest" your organs unless you've left clear instructions otherwise.

The second problem is rejection. A transplanted organ has DNA that is different from the recipient's, which can cause the immune system to treat it as an invader. So transplants usually come with drugs that suppress the immune system, leaving the patient vulnerable to other infections. If we were able to grow new organs to order, from cells with the patient's own DNA, it would solve both these problems.

But stem cells have political problems, particularly in the US, where president George W Bush severely limited research funding because the main source for stem cells were embryos, usually those left over after in-vitro fertilisation but potentially from abortions. Those restrictions have been gradually eased, but more than a dozen states also have strict rules in place.

The stem cells used by the Japanese team, however, have a different source. Called "induced pluripotent stem" cells, they are made from tissue cells that have been treated to return them to a state similar to that of stem cells. No embryo, no political problem.

But real stem cells would be better. And one of the best places to find them in adults, it turns out, is in teeth. Some companies are even harvesting people's dental pulp stem cells and storing them in case they're needed in future. Soon it may be possible not only to regrow teeth, but to regrow other organs from teeth.

Originally posted here:
Losing your teeth?