StemCell Therapy

GRAND RAPIDS, Mich., April 19, 2012 /PRNewswire/ --Researchers at Lund University in Sweden have discovered a new stem cell in the adult brain. These cells can proliferate and form several different cell types -- most importantly, they can form new brain cells. Scientists hope to take advantage of the finding to develop methods to heal and repair disease and injury in the brain.

Analyzing brain tissue from biopsies, the researchers for the first time found stem cells located around small blood vessels in the brain. The cell's specific function is still unclear, but its plastic properties suggest great potential.

"A similar cell type has been identified in several other organs where it can promote regeneration of muscle, bone, cartilage and adipose tissue," said Patrik Brundin, M.D., Ph.D., Jay Van Andel Endowed Chair in Parkinson's Research at Van Andel Research Institute (VARI), Head of the Neuronal Survival Unit at Lund University and senior author of the study.

In other organs, researchers have shown clear evidence that these types of cells contribute to repair and wound healing. Scientists suggest that the curative properties may also apply to the brain. The next step is to try to control and enhance stem cell self-healing properties with the aim of carrying out targeted therapies to a specific area of the brain.

"Our findings show that the cell capacity is much larger than we originally thought, and that these cells are very versatile," said Gesine Paul-Visse, Ph.D., Associate Professor of Neuroscience at Lund University and the study's primary author. "Most interesting is their ability to form neuronal cells, but they can also be developed for other cell types. The results contribute to better understanding of how brain cell plasticity works and opens up new opportunities to exploit these very features."

The study, published in the journal PLoS ONE, is of interest to a broad spectrum of brain research. Future possible therapeutic targets range from neurodegenerative diseases to stroke.

"We hope that our findings may lead to a new and better understanding of the brain's own repair mechanisms," said Dr. Paul-Visse. "Ultimately the goal is to strengthen these mechanisms and develop new treatments that can repair the diseased brain."

Link to the study here:

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0035577

About the Neuronal Survival Unit, Faculty of Medicine, Lund University

Read the rest here:
New Stem Cell Found in the Brain

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

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of the third patient in its Phase I/II trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The outpatient transplantation surgery was performed successfully, and the patient is recovering uneventfully.

Gary Rabin, chairman and CEO of ACT, commented, The completion of enrollment of the first cohort of patients in our dry AMD clinical trial is a significant step forward in our RPE clinical program. The first six patients in the U.S. trials have all been treated at UCLA, and as we have recently announced, the trials should soon expand to additional sites. As we have built our clinical team, we have been fortunate to have attracted the attention of some of the highest-caliber ophthalmologists and related institutions in the U.S. and Europe and recognize the huge value that their expertise provides us as we plan for the future of our therapeutic programs. With their guidance, we have also worked with the FDA to successfully expand the criteria of eligibility for patients to participate in our dry AMD trial.

The procedures at UCLA were all conducted by the team led by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute.

The six patients treated at UCLA to date have tolerated the surgical procedure well. commented Dr. Schwartz. There have been no complications in the procedure, nor any issues relating to the safety of the injected stem cell-derived RPE cells in any of the patients. We continue to regularly evaluate all patients in the trial, and while still preliminary, I am encouraged by the patients progress and the relative straightforwardness of the surgical procedure.

We are extremely pleased with the progress being made in all three of our clinical trials here in the U.S. and the U.K., commented Robert Lanza, M.D., ACTs chief scientific officer. The data we are reviewing seems to be pointing in the appropriate direction, With the treatment of the latest two dry AMD patients, we look forward to having more significant points of reference to understand the progress of the trial and consider the endpoint design for the next phase. Both Stargardts disease and dry AMD are progressive diseases that result vision loss and blindness due to the thinning of the layer of RPE cells in the patient's macula, the central portion of the retina responsible for central vision. We still have many patients left to treat during the course of these trials, but our team remains hopeful that stem cell-derived RPE cells may someday provide a new therapeutic approach for the treatment of many forms of macular degeneration. We hear from patients who suffer from these diseases on nearly a daily basis, and appreciate the huge responsibility we have to them.

ACT is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration. Each trial will enroll a total of 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 dry-AMD or Stargardt's macular dystrophy (SMD) at 12 months, the studys 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 Companys U.K. clinical trial was treated at Moorfields Eye Hospital in London. The final patient of the first cohort in the companys SMD trial in the U.S. was treated on February 13, 2012.

Further information about patient eligibility for the dry AMD study and the concurrent study on SMD is also available on http://www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 , NCT01469832 and NCT01344993.

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.

Here is the original post:
ACT Announces Third Dry AMD Patient Treated in Clinical Trial

Photo by Allie Garza

Dr. Zannos Grekos, a cardiologist whose practice is in Bonita Springs, speaks with a seminar attendant after one of his educational seminars about stem cell treatment, using one's own stem cells, for treating heart disease and other medical conditions, on Monday, March 14, 2011, at the Collier County Library. Allie Garza/Staff

K.K.Yankopolus

In a case involving a criminal investigation into the recent death of a 77-year-old man after stem cell treatment, state health authorities say Dr. Zannos Grekos extracted tissue from the patient while a second doctor later injected the patient with his own concentrated stem cells.

But when Grekos, a Bonita Springs cardiologist, initially harvested fatty tissue from Richard Poling's stomach on March 2, he unknowingly damaged the patient's abdomen which led to bleeding, according to a state Department of Health complaint.

New documents obtained by the Daily News shed more light on the case of Grekos and Dr. Konstantine Yankopolus, a Fort Myers obstetrician who assisted Grekos. They face potential disciplinary action from the state Board of Medicine for doing a stem cell treatment that the state says was experimental and dangerous.

The state issued separate administrative complaints against them in late March and early April, a few weeks after Poling died the same day of the treatment. He suffered a cardiac arrest in Grekos' practice on Bonita Beach Road and was pronounced dead at NCH North Naples Hospital.

The Lee County Sheriff's Office launched a criminal investigation in early March and it is ongoing, agency spokesman Larry King said.

Grekos also faces potential discipline when the state restricted his license in February, 2011 in connection to the death of a 69-year-old woman who went to him in 2010 for stem cell therapy.

She sought a remedy for neurological damage after chemotherapy for breast cancer. She fell in her home after the treatment, suffered a brain injury and later was taken off life support.

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State: Grekos extracted tissue from stem cell patient who died, damaged patient's abdomen

Public release date: 17-Apr-2012 [ | E-mail | Share ]

Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Tampa, Fla. (April. 17, 2012) Combined, complimentary therapies have the ability to maximize the benefits of neural stem cell (NSC) transplantation for spinal cord repair in rat models, according to a study carried out by a team of Korean researchers who published in a recent issue of Cell Transplantation (20:9), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/.

"When transplanted, neural stem cells have demonstrated their therapeutic potential to reverse complex pathological processes following spinal cord injury," said study corresponding author Dr. Byung G. Kim of the Ajou University School of Medicine's Brain Disease Research Center and Department of Neurology, Republic of Korea. "However, many obstacles cannot be overcome by NSC transplant alone."

Their study demonstrated that a combination of treatment strategies - a polymer scaffold, neurotrophin-3 (NT3) and chondroitinase (an enzyme which helps digest the glial scar that formed after a spinal cord injury) - provided added therapeutic benefits to NSC transplantation. The implantation of a polymer scaffold designed to bridge lesion cavities, created a favorable tissue environment for nerve growth. Incorporating the NT3 gene into the transplanted cells improved cell survival and migration while the addition of chondroitinase positively affected neural activity between the scaffold and the spinal cord.

"The poly (-caprolactone) [PCL] scaffold in our study appeared to function like a reservoir supplying migratory NSCs to the spinal cord," said Dr. Kim. "The NSCs grafted with the scaffolds survived the transplantation and migrated to the host spinal cord."

The study included four animal groups, only one of which received the full combination of therapies. Rats in the full combination therapy group were found to have some restored neuroplasticity and enhanced remyelation of contralateral white matter. All four groups subsequently underwent functional testing for locomotor recovery.

"Rats in the full combination group attained well-coordinated plantar stepping accompanied by improved ankle positioning and toe clearance and reduced paw placement errors," explained Dr. Kim. "Furthermore, animals with the full complement of combination strategies responded to transcranial magnetic stimulation."

The researchers concluded that, given their success, similar treatment for humans should be carried out in a chronic injury setting.

"We believe that our results have important clinical implications regarding the future design of NSC-based therapeutic strategies for human victims of traumatic spinal cord injury," concluded Dr. Kim and co-authors.

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Neural stem cell transplants for spinal cord injury maximized by combined, complimentary therapies

BOSTON--(BUSINESS WIRE)--

Inform Genomics, Inc., a private company focused on developing novel platforms of personalized medicine products for cancer supportive care and inflammatory diseases, today announced the completion of the first phase of product development to predict a patients risk of developing oral mucositis after receiving high dose chemotherapy prior to hematopoietic stem cell transplant. The results of this single center, 153-patient study demonstrated the products ability to discriminate which patients develop oral mucositis with 99.3% accuracy and an area under the Receiver Operator Characteristic (ROC) curve of 99.7%. Further development will include validation of these initial results in a multicenter study. In addition, Inform Genomics announced that it entered into a collaboration agreement with Swedish Orphan Biovitrum AB (Sobi) to further develop and commercialize the product. Sobi is a leading integrated biopharmaceutical company dedicated to bringing innovative therapies and services to improve the health of rare disease patients and their families.

We are very pleased with the exciting results of this study, said Ed Rubenstein, M.D., President & CEO of Inform Genomics, and our agreement with Sobi demonstrates the value our technology can bring to biopharma partners while expanding the market opportunity for both companies products. When commercialized, this product will be available for the hematology oncology stem cell transplant market and will complement the target market of our lead product, OnPART for patients with solid tumors.

The principal investigator for the study, Stephen T. Sonis, D.M.D., D.M.Sc., Chief Scientific Officer of Biomodels, LLC, who also serves as the Chief of the Division of Oral Medicine at the Dana-Farber Cancer Institute and Professor of Oral Medicine at the Harvard School of Dental Medicine, will present the results of the study at the upcoming 2012 American Society of Clinical Oncology (ASCO) Annual Meeting, as part of the educational session titled Mucosal Injury in Patients with Cancer: Targeting the Biology, taking place from 11:30 am to 12:45 pm on Sunday, June 3, 2012 in Chicago, IL.

About OnPART

OnPART, Oncology Preferences And Risk of Toxicity, will be Inform Genomics first platform molecular diagnostic test for personalizing treatment decisions for patients undergoing chemotherapy for colorectal, breast, lung or ovarian cancer. Based upon response rates and survival, more than one chemotherapy regimen may be considered appropriate care for patients with these common solid tumors, yet the regimens vary widely in their toxicity profiles, including nausea & vomiting, diarrhea, oral mucositis, cognitive dysfunction, fatigue and peripheral neuropathy. OnPART is being developed to assess genomic risk for these side effects, and to provide valuable information for patients and medical oncologists to help clarify clinical choices.

About Inform Genomics

Inform Genomics, Inc. is a private company focused on developing novel platforms of personalized medicine products for cancer supportive care and inflammatory diseases, including its lead product, OnPART, designed to predict an individuals risk of six common toxicities of commonly used chemotherapy regimens based on his or her individual genomic profile. The Companys business model leverages existing technology in conjunction with proprietary analytic methods for conducting genome-wide association studies. Product development programs will lead to commercial, single source laboratory tests consisting of single-nucleotide polymorphism (SNP) clusters that determine the likelihood of individual patient clinical outcomes to drug therapies. The U.S. market opportunity for these differentiated products exceeds $2 billion annually. Inform Genomics is headquartered in Boston, Massachusetts. For more information, please visit http://www.informgenomics.com.

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Inform Genomics Announces Results of Study Predicting Risk of Oral Mucositis in Patients Undergoing High Dose ...

CAMBRIDGE, Mass., April 17, 2012 /PRNewswire/ --ETEX Corporation, an advanced biomaterials company, today announced two presentations at the upcoming Global Technology Community 8th Stem Cell Summit, April 19-20, 2012 at the Hyatt Harborside Hotel in Boston, MA. ETEX will highlight their cell carrier development program in two concurrent tracks: Stem Cell Commercialization & Partnering as well as Stem Cell Research & Regenerative Medicine.

(Logo: http://photos.prnewswire.com/prnh/20080424/NETH117LOGO )

Brian Ennis, President and CEO of ETEX Corporation, will deliver an oral presentation entitled "Orthobiologic Market Dynamics, Vision of the Future" during the Stem Cell Commercialization & Partnering session. Mr. Ennis will highlight key elements of a product lifecycle / replacement technology business model, outlining a new approach to skeletal repair and orthopedic innovation. This approach incorporates the combination of biomaterials and hardware, localized bone treatment with systemic therapy and stem cell delivery.

Dr. David Kaplan, Tufts University and Dr. Jerry Chang, ETEX Corporation scientific team will showcase recent advancements in their Stem Cell Carrier program during the Stem Cell Research & Regenerative Medicine session. The poster & power point presentation is entitled "Calcium Phosphate Combination Biomaterials as Human Mesenchymal Stem Cell (hMSC) Delivery Vehicles for Bone Repair".

Brian Ennis comments, "As a pioneer in growth factor and cell delivery technology, ETEX is excited to participate in this important event. We believe a cell carrier/scaffold is a grossly underestimated critical element for the successful execution of cell therapy in skeletal repair and soft tissue regeneration."

Questions regarding ETEX's participation may be directed to Jerry Chang, PhD., jchang@etexcorp.com or 617-577-7270.

About ETEX Corporation Established in 1989, ETEX Corporation develops, manufactures and commercializes calcium phosphate-based biomaterials for improved orthopedic clinical outcomes. A leader in bioresorbable bone substitute materials, ETEX focuses on expanding applications through combinations with cells, biologics, or therapeutic agents delivered in minimally invasive and easy to use systems. For more information, visit http://www.etexcorp.com.

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ETEX Corporation to Present at GTC Stem Cell Summit

WESTON, Fla., April 17, 2012 (GLOBE NEWSWIRE) -- Stemlogix, a regenerative medicine company offering premier in-clinic stem cell therapy solutions to veterinarians, announced today that it has selected Butler Schein Animal Health(TM) to distribute its regenerative medicine system, stem cell therapy kits and other biological therapies. Butler Schein Animal Health(TM) - a Henry Schein Company - is the largest companion animal health distribution company in the U.S.

Based in the U.S., Stemlogix is an innovative leader in the rapidly emerging field of veterinary regenerative medicine. The Company develops and manufactures stem cell therapy kits and platelet rich plasma kits domestically according to FDA cGMP regulations. Stemlogix offers scientifically validated technologies and protocols that will enable veterinarians to provide their patients with affordable, versatile regenerative medicine solutions including adipose (fat) and bone marrow derived stem cells, platelet rich plasma (PRP) and cytokine therapies at the point-of-care, all in less than 90 minutes. The Company also offers stem cell banking and stem cell expansion services to veterinarians around the country.

Butler Schein Animal Health(TM) will now offer the Stemlogix regenerative medicine system to its network of over 26,000 veterinary clinics in the U.S., helping Stemlogix to expand its market presence across North America. "We are excited to be working with Butler Schein to offer the Stemlogix in-clinic regenerative medicine system to their vast network of veterinarians," said Kristin Comella, CEO of Stemlogix. "This partnership will enable Stemlogix to help standardize and advance the field of regenerative medicine."

Clinical research has shown that regenerative stem cell therapies have been safely and effectively used to treat degenerative diseases and acute tissue injuries including arthritis, laminitis, tendon injuries and ligament injuries. Stemlogix has developed an array of convenient, affordable, same-day regenerative therapies designed to achieve reproducible and superior clinical outcomes. Stemlogix also has developed an innovative technique to remove stem cell rich fat tissue from horses in a minimally invasive, scar-free method, called Equine VetLipo(TM).

About Stemlogix, LLC

Stemlogix is an innovative veterinary regenerative medicine company committed to providing veterinarians with the ability to deliver the best possible stem cell therapy to dogs, cats and horses at the point-of-care. Stemlogix provides veterinarians the ability to produce PRP and isolate regenerative stem cells from a patient's own fat tissue or bone marrow in their own clinic. Stemlogix is the first company to provide veterinarians with the ability to produce multiple cellular therapies using the same system and the company offers the most versatile regenerative medicine system available. Stemlogix has a full scale cGMP stem cell manufacturing facility and a scientific team with expertise in developing stem cell products, FDA compliance and clinical research. For more information about veterinary regenerative medicine please visit http://www.stemlogix.com.

About Butler Schein Animal Health(TM)

Butler Schein Animal Health (Butler Schein) -- the veterinary division of Henry Schein (Nasdaq: HSIC - News) is the leading companion animal health distribution company in the United States headquartered in Dublin, Ohio. Butler Schein employs approximately 900 team members including 300 field sales representatives and 200 telesales and customer support representatives. With 15 strategically positioned, state-of-the-art distribution facilities and 10 inside sales centers nationwide, we maintain 98%+ order-fill ratio, accomplishing our mission of providing the right product at the right place and at the right time.

Partnering with over 400 leading animal health manufacturers in the world, Butler Schein is positioned to bring the broadest selection of veterinary products and strategic solutions to veterinary professionals nationwide, including:

1.

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Stemlogix Selects Butler Schein Animal Health to Distribute Versatile In-Clinic Stem Cell Therapy System to ...

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Via Scoop.it – inPharmatics

Biopharmaceutical vendor AstraZeneca has launched a unified communications pilot using Microsoft Lync to improve collaboration among pharmaceutical sales reps, doctors and researchers.
Via mobile.eweek.com

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Michael West, CEO of Biotime, Inc.of Alameda, Ca., has published the text of his prepared remarks to the Institute of Medicine panel examining the performance of the $3 billion California stem cell agency.

Here is one excerpt from the statement by West, who was also CEO at Advanced Cell Technology and founded Geron.

"To put it simply, stem cell research by itself will not lead to cures. Research and DEVELOPMENT leads to cures. In my opinion, if CIRM fails to deliver on its goal to deliver cures, it will not be a result of internal governance issues. Instead, it will be a result of inefficient capital allocation. A graphic way of visualizing my point is to say that CIRM has historically funded primarily research, and little product development, i.e. large “R” little “d”. Approximately 5% of CIRM’s expenditures have been allocated to biotechnology and health science entities whose expertise is product development, and 95% has been allocated to nonprofit institutions in the state for basic research. Human therapeutic product development in the United States requires a very intense and expensive process for approval that is primarily focused on development side of the equation. In this respect, therapeutic approvals differ significantly from the discovery and development of silicon-based technologies that have been so successfully commercialized in California."

Here is a link to the full text of what West posted on the Biotime web site.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

A venture capitalist who said earlier this week that the California stem cell agency rejected 15 grant applications from Advanced Cell Technology this afternoon retracted the statement, which he said was incorrect.

Gregory Bonfiglio, managing partner in Proteus Regenerative Medicine, said in an email,

"Although I believed that number to be true at the time I stated it, I have now determined that the number of CIRM grant applications ACT filed as the principal investigator was substantially below 15."

Bonfiglio made the assertion Tuesday at a meeting of the Institute of Medicine panel looking into the performance of the $3 billion California stem cell agency, which has been criticized for its lack of funding of biotech firms.

Here is more of what Bonfiglio had to say in his email this afternoon,

"Unfortunately, your California Stem Cell Report posting on April 11 contains some inaccurate information, for which I appear to have been the source.  As you will recall, I stated during the IOM Panel that Advanced Cell Technology had submitted multiple applications for funding from CIRM, but had been unsuccessful in obtaining any funding from CIRM.  I also stated that ACT had been involved in “15 grant applications” to CIRM.   You highlighted that number in your April 11 California Stem Cell Report posting.   Unfortunately, that number is not accurate.  Although I believed that number to be true at the time I stated it, I have now determined that the number of CIRM grant applications ACT filed as the Principal Investigator was substantially below 15.   The number I quoted in the IOM Meeting on April 10 included applications in which ACT had some involvement, but was not the lead principal Investigator.  ACT has filed several applications for CIRM funding as the lead PI, but the number of CIRM applications in which ACT was the lead PI was far below 15.   Moreover, some of ACT’s direct applications for CIRM funding were withdrawn by ACT, rather than denied by CIRM.

"I would request that you correct this inaccuracy regarding ACT's applications for CIRM funding as soon as possible.  I'm sure you will agree that the regenerative medicine community, and the general public, have a real and significant interest in obtaining accurate information about developments at CIRM, and that the publication of inaccurate information is a tremendous disservice to all involved.  More importantly, ACT is a publicly traded company and the publication of inaccurate information regarding ACT, its technologies, or its funding could have adverse consequences for the company.   Furthermore, as an active participant in the regenerative medicine community who has spent his professional career developing a reputation for honesty, accuracy, and integrity I am very concerned that I might be the source of inaccurate information regarding developments within the field of regenerative medicine.  For these reasons, I would ask that you retract the statement in your April 11 Blog posting that ACT was 'rejected 15 times for funding' by CIRM, and that you refrain from making any other statements to that effect.

"I appreciate your cooperation in this regard, and I would request that you move quickly to correct the inaccuracy in your April 11 Blog posting.   As I am sure you are aware, information in blog postings is sometimes picked up by more traditional media, and I would not want any republication of this inaccurate information regarding ACT’s grant applications to CIRM."

At the time Bonfiglio made his comments concerning ACT, top officials of the stem cell agency were in the room, but did not make any statement concerning his assertion. On the morning of April 11 prior to publication of the item, the California Stem Cell Report asked ACT for comment .

No response has been received from ACT about the figure. CIRM also has not commented since the item appeared.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

IRVINE, Ca. – The $3 billion California stem cell agency was praised this week for making progress in accountability and transparency during the last year.

The comments came from a representative of California state Controlller John Chiang, the state's top fiscal officer and who also chairs the only state entity specifically charged with financial oversight of the stem cell agency and its board.

Ruth Holton-Hodson, deputy state controller, told the blue-ribbon Institute of Medicine panel examining the performance of the stem cell agency that the controller's office "would like to acknowledge the progress the new leadership has made in the last year towards making CIRM a far more transparent and accountable agency than it has been in the past."

CIRM has a new chairman, J.T. Thomas, a Los Angeles financier, who has been in place since the beginning of last July. He succeeded Bob Klein, who was the initial agency chairman and who took office in 2004.

In her testimony at the IOM hearing here on Tuesday, Holton-Hodson discussed previous problems that CIRM had with the transparency of its budget. She said,

"We are very pleased that CIRM’s new leadership recognized this as a problem and quickly adopted a much more transparent budget format which is broken down by function. To make CIRM’s expenditures as transparent as possible, we have also recommended that they post the annual budget on the website. Again, we’re pleased to say that the new leadership has agreed to do this."

She also said,

"At our most recent meeting (of the Citizens Financial Accountability and Oversight Committee), we also recommended that CIRM post all of its private donations and they have agreed to do this."

Holton-Hodson criticized the dual executive arrangement at CIRM that is written into law by Proposition 71. She said,

"It is difficult to uphold the appearance of accountability and objectivity when the board chair has direct line authority over some CIRM staff positions. In essence under the current model, the chair is responsible for evaluating and approving some of the work of the chair.

"While this issue is still outstanding, it is important to acknowledge that the current leadership has made significant progress in more clearly delineating the responsibilities of the chair and the president."

Here is the full text of Holton-Hodson's remarks.Statement from California state controller's office to IOM-CIRM panel April 10, 2012

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

(Editor's note: The assertion in this item that 15 applications by ACT were rejected by the California stem cell agency is incorrect, according to the venture capitalist who made the statement. He retracted it on the afternoon of April 12. His explanation can be found here. )


IRVINE, Ca. --The only firm in the nation conducting an ongoing hESC clinical trial has been rejected 15 times for funding by California's $3 billion stem cell agency.

The figure was reported yesterday at a hearing by the blue-ribbon Institute of Medicine panel looking into the performance of the stem cell agency, which has been sharply criticized in recent years for its paucity of industry funding.

Gregory Bonfiglio, managing partner in Proteus Regenerative Medicine, a stem cell venture capital firm in Portola Valley, Ca., disclosed the grant attempts by Advanced Cell Technology, whose nominal headquarters are in Santa Monica, Ca. Bonfiglio indicated that it was a high profile example of how CIRM is not taking the necessary steps to fulfill its goal of developing therapies that actually reach the clinic.

He noted that ACT received national attention in January when it posted favorable findings for its clinical trial at UCLA dealing with blindness but that the firm was still unable to win a CIRM grant over the last several years.

ACT had moved much of its operations to California in the wake of passage of Proposition 71, the measure that created the state's stem cell research effort in 2004. It has since re-centered its operations in Massachusetts.

The California Stem Cell Report has queried ACT on its grant efforts and will carry its response verbatim when it is received.

Another firm, which cannot be identified, said privately yesterday that it was rejected 14 times.

According to our calculations based on figures this morning on the CIRM web site, businesses have received only $54.3 million in grants and loans during the last seven years, 4 percent of the $1.3 billion awarded. However, the CIRM list slightly understates the industry total. At least two other firms are sharing in two $20 million grants involving academic institutions, but are not noted on the list.

Yesterday's IOM meeting was the second and final California public session for the CIRM inquiry. Most of the day was occupied by a variety of critiques of the organization. The panel has already heard extensively from the agency itself and beneficiaries of its grants. The IOM report is expected in November.

Harold Shapiro, chairman of the panel and former president of Princeton University, described yesterday afternoon's panel involving stem cell business executives as "one of the more interesting" of the day.

One of the speakers was Michael West, CEO of Biotime in Alameda, which has received $4.7 million from CIRM. West, the founder of Geron, was also head of ACT when it moved it to California. He said CIRM had several "blind spots," including misconceptions about how products are made. For example, West said, CIRM's performance indicates that it does not fully understand that development leads directly to cures -- not research.

West said that if the high tech industry had to rely on CIRM-type funding years ago, laptops and iPads would still be in the lab instead of the marketplace.

The business industry representatives said that creation of CIRM has been beneficial for stem cell  research, but cited a number of deficiencies in connection with industry applications.

In some ways, their comments echoed past remarks by several CIRM board members, who have expressed concern about the lack of funding for industry, as well as those of the agency's own external review panel. One issue raised by those CIRM directors has been the lack of grant reviewers with product development and industry expertise.

At yesterday's hearing, Gabriel Nistor, vice president of research and development at California Stem Cell in Irvine, said, it is "exceedingly rare to find academics (grant reviewers) that understand the complexities" involving industry. Nistor said his firm has applied for a "few" CIRM grants. None have been awarded.

Also speaking was Allan Robins, CEO of Viacyte in San Diego, who said his firm has done well with CIRM funding. It has received $26.2 million, nearly all of it in the form of a loan. But he said companies develop products – not academia.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

IRVINE, Ca. – The Center for Genetics and Society today said it would "wrong" to ask the people of California for more money to continue financing stem cell research at state expense.

Marcy Darnovsky, associate executive director of the Berkeley, Ca., non-profit group, addressed a blue-ribbon Institute of Medicine panel evaluating the performance of the $3 billion California stem cell agency, which is financed by money borrowed by the state. The agency is expected to run out of cash in about five years.

Darnovsky said,

"In structural terms, a key question now is what will happen after CIRM’s public funding is exhausted. According to CIRM’s transition plan, another bond measure for additional public funding 'would be premature at this time,' but is still on the table. In our view, any additional public monies for CIRM would have to be justified in an analysis that emphasized health care priorities and health care disparities. While there is always tension between the allocation of public funds to scientific research and to other public goods, given our state’s economic decline and budgetary crisis, with so many critical social programs being gutted, we believe it would be simply wrong to ask Californians to set aside more money for one avenue of research, however important."

Representatives of the stem cell agency were present at today's hearing on the UC Irvine campus, but did not speak publicly at today's session. CIRM officials, however, have testified before the panel on two other days of public hearings. The agency is paying the IOM $700,000 to conduct the study. Its results and recommendations are expected to be published in November.

Darnovsky and others testifying at the morning session were critical of the agency's lack of accountability, built-in conflicts of interest and immunity from normal government oversight (see here and here).

Darnovsky said, "

The requirement for 70% super-majorities (to change the law regarding CIRM) means that there is still no meaningful oversight of CIRM by elected officials. The ICOC is still tainted by its built-in conflicts of interest. It still includes no representation of the public beyond disease advocates. Members of CIRM’s powerful Working Groups, including the one that reviews grant applications, are still not required to publicly disclose their individual financial interests.

"Given that hundreds of millions of dollars remain to be disbursed, and the widely mooted possibility that CIRM will develop a role that continues beyond the public funding stream that was allocated in 2004, now is the time to clarify and address these issues."

Here is the full text of Darnovsky's comments.
Center for Genetics and Society statement to IOM-CIRM panel, April 10 2012

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

IRVINE, Ca.-- California's unprecedented stem cell research effort faces a tight timetable for making major progress in fulfilling promises to voters seven years ago, complicated by potential conflicts of interest, a blue-ribbon panel was told this morning.

David Jensen, editor of the California Stem Cell Report, made the comments to the Institute of Medicine panel looking into the performance of the $3 billion California Institute of Regenerative Medicine.

The panel's inquiry comes as the agency is re-evaluating its strategies as it faces loss of funding in about 2017.

Here is the full text of Jensen's statement.
Statement to IOM-CIRM Panel by California Stem Cell Report April 9, 2012

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IRVINE, Ca. – The Consumer Watchdog organization says that serious consideration should be given to whether the state should halt borrowing money to finance the $3 billion California stem cell agency.

The statement was prepared for delivery tomorrow here to a blue-ribbon Institute of Medicine panel evaluating the performance of the research effort, which was created by a ballot initiative in 2004. The agency's only real source of cash is bonds issued by the state, which means the agency will cost $6 billion including interest by end of its grant-making life in about 2017.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., said that the political and scientific environment has changed substantially since 2004. The Bush Administration had restricted federal funding of hESC research then, causing an uproar in the scientific community. Funding has since been restored.

Simpson said the stem cell measure "made sense" seven years ago. He said the stem cell agency and its governing board "must recognize that the political, scientific and economic environment have dramatically altered since the passage of Proposition 71."

His statement continued,

"It is also appropriate to consider seriously whether issuing all $3 billion in authorized bonds is the correct policy in light of the new environment and economic realties facing the state."

Simpson was invited make his statement to the IOM panel, which is midway through its public process of looking into CIRM's operations. It is doing so at the behest of CIRM, which is paying the prestigious organization $700,000 to perform the work.

Simpson also made a number of recommendations for changes at CIRM, many of which would require a change in state law or passage of another ballot measure. Proposition 71, which created CIRM and altered the state Constitution, requires a super, super-majority vote (70 percent) by the legislature to make changes at CIRM.

The Consumer Watchdog proposals (full text below) include reducing the size of the 29-member board to 15, including public members on the board, reducing the super-majority requirement on board quorums to a majority, eliminating the controversial dual executive arrangement at CIRM, conducting grant reviews in public and publicly disclosing the financial interests of reviewers.Consumer Watchdog Statement to IOM-CIRM Panel April 9, 2012

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Via Scoop.it – inPharmatics

Biopharmaceutical vendor AstraZeneca has launched a unified communications pilot using Microsoft Lync to improve collaboration among pharmaceutical sales reps, doctors and researchers.
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