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Archive for the ‘Stem Cell Therapy’ Category

Ireland could be stem cell research hub

Wednesday, July 4th, 2012

Tuesday, July 03 16:25:12

Ireland has the capacity to be an international centre for commercialisation in the field of regenerative medicine, delegates at an international stem cell conference in NUI Galway heard today.

Reflecting this potential, new Irish company Orbsen Therapeutics is developing proprietary technologies designed to isolate stem cells. The NUI Galway spin-out is targeting the rapidly maturing and expanding regenerative medicine market, which is expected to grow to $118 billion next year.

Frank Barry is Professor of Cellular Therapy at NUI Galway, Director of Orbsen Therapeutics, and organiser of the Mesenchymal Stem Cell Conference, which opened yesterday.

Mesenchymal stem cells (MSCs) are a type of adult stem cell, and this event brings together the world's leading scientists in the field to discuss their latest ideas and findings. This is the first major stem cell conference to take place in Ireland, and is looking at all aspects of adult stem cells, from basic biology to manufacturing to clinical trials and therapeutics.

Stem cells hold great promise as an alternative to drugs and surgical procedures for treating a wide range of medical conditions including heart disease, arterial disease of the limbs, diabetes complications, arthritis and other inflammatory conditions. The treatment potential of stem cells is linked to their natural capacity to dampen inflammation and promote healing, repair and regeneration of damaged tissues.

According to Professor Barry: "Ireland has a strong research base in adult stem cell therapy and has the capcacity for advanced stem cell bioprocessing. There is huge potential in this market and we anticipate that there will be extraordinary growth over the next 5-10 years. There are currently over 400 regenerative medicine products on the market with many more in development." Orbsen Therapeutics has developed a clear pipeline of clinical indications which they hope, using their proprietary technologies, to bring through to clinical trial over the coming years. These include osteoarthritis, acute lung injury syndrome, diabetic foot ulcer, critical limb ischemia and others."

"Combining the utility, novelty and the value of its technologies, Orbsen is well placed to take advantage of the many opportunities in this fast moving and important emerging market", said Brian Molloy, CEO of Orbsen Theraepeutics."

Orbsen Therapeutics Limited was formed as a spin out company to develop and commercialise new intellectual property built up by researchers at the SFI-funded Regenerative Medicine Institute (REMEDI) at NUI Galway.

Scientists at NUI Galway are investigating how adult stems cells might be used to develop new treatments for vascular disease, osteoarthritis and lung injury. The University has become a leading centre of translational research in adult stem cells involving its National Centre for Biomedical Engineering Science (NCBES) and REMEDI.

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Ireland could be stem cell research hub

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Stem Cell Therapy Shown to be Effective in Treating Liver Cirrhosis

Wednesday, July 4th, 2012

SHENZHEN, China, July 3, 2012 /PRNewswire-Asia/-- A study conducted by Beike Biotechnology Company (http://www.beikebiotech.com) in conjunction with physicians and researchers at two Chinese hospitals, documents the effectiveness of cord blood-derived stem cells in treating primary biliary cirrhosis (PBC). The study, which was published in the April 2012 issue of the Stem Cell Discovery, was the first of its kind. Researchers noted that additional clinical trials would be required before stem cells can become an accepted therapy for liver cirrhosis.

Prof. Jin-hui Yang, Director of the Department of Hepatology in the 2nd Affiliated Hospital of Kunming Medical College stated, "Given the severity of liver cirrhosis and its related conditions, and the limited number of options available to treat those who suffer from it, this finding represents an important, potentially significant breakthrough."

PBC is a chronic, progressive liver disease that leads eventually to fibrosis and cirrhosis of the liver. It affects 1 in 1,000 women over the age of 40.Approximately one-third of those who suffer from PBC and its related conditions do not respond well to Ursodeoxycholic acid (UDCA) treatment, which is the only currently FDA-approved standard medical treatment for the condition. Many of those patients ultimately require liver transplantation.

Beike Chairman, Dr. Sean Hu, commented, "With a growing body of research that demonstrates the effectiveness of cord blood-derived stem cell therapies in treating a broad range of chronic conditions, this latest study is a milestone in the continuing effort to gain broad acceptance and recognition of regenerative medicine as a mainstream treatment option.We look forward to conducting more comprehensive clinical trials to attempt to validate the positive outcomes we have already observed."

The case study reported in the Stem Cell Discovery involved a 58 year old woman suffering from PBC who developed an incarcerated hernia and uncontrolled hydrothorax after undergoing UDCA treatment.One week after completing two stem cell transplantations with no observed adverse effects, the patient showed improvement in both liver function and in her general condition. She was released from the hospital but continued to receive twice-daily UDCA treatments. Six months after her discharge, doctors observed continued improvements in her liver function and overall condition.

To review the full text of the published study, please visit: http://www.scirp.org/journal/PaperInformation.aspx?paperID=18710. Study authors included physicians and researchers from the 2nd Affiliated Hospital of Kunming Medical College, Beike Biotechnology Company, and the Yunnan Provincial 1st People's Hospital in Kunming, China.

About Beike Biotechnology Company

Shenzhen Beike Biotechnology Co., Ltd. is China's leading biotechnology company focusing on the production of adult stem cells for use in medical therapies. Headquartered in Shenzhen (near Hong Kong) with a flagship regenerative medicine facility at the China Medical City in Jiangsu province, Beike produces a full line of stem cell products derived from umbilical cord, cord blood and autologous bone marrow.

For any questions regarding this release, please call:

Contact Person: T. Gutmann Phone Number: +86-532-6677-6659

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Stem Cell Therapy Shown to be Effective in Treating Liver Cirrhosis

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Former Auburn coach getting stem cell treatments for Lou Gehrig's disease

Saturday, June 30th, 2012

MOBILE, Alabama -- The Baldwin County doctor that treated former Alabama football players with adult stem cells also has treated at least two people diagnosed with amyotrophic lateral sclerosis, also known as Lou Gehrigs disease.

One of the ALS patients, former NFL football player and college coach Frank Orgel, recently underwent a new stem cell reprogramming technique performed by Dr. Jason R. Williams at Precision StemCell in Gulf Shores.

Before the injections, Orgels health had declined. He could not move his left arm or leg. He couldnt walk or stand on his own, he said.

Within a few days of having the stem cell treatment, Orgels constant muscle twitching diminished, said Bob Hubbard, director of stem cell therapy at the practice. Within weeks, he was able to walk in a pool of water and stand unassisted.

I think its helped me, said Orgel, who was a defensive coordinator at Auburn under former head coach Pat Dye. Im walking in the pool and I used to drag my feet. Now my left leg is picking up.

ALS is a progressive neuro-degenerative disease that affects nerve cells in the brain and the spinal cord. The progressive degeneration of the motor neurons in ALS eventually leads to death, according to the ALS Association.

Stem cells, sometimes called the bodys master cells, are precursor cells that develop into blood, bones and organs, according to the U.S. Food and Drug Administration, which regulates their use. Their promise in medicine, according to many scientists and doctors, is that the cells have the potential to help and regenerate other cells.

While Williams treatments are considered investigational, he has said, they meet FDA guidelines because the stem cells are collected from a patients fat tissue and administered back to that patient during the same procedure.

Orgel, 74, said Williams told him it would take between eight months to a year for his nerves to regrow. He is traveling to Gulf Shores from his home in Albany, Ga., this weekend for another stem cell treatment, Orgel said: I need to get to where I can walk.

In recent years, Orgel has gone to Mexico at least three times for different types of treatments, not sanctioned in the U.S. At least once, he said, he had placenta cells injected into his body. That didnt work, Orgel said. I didnt feel any better.

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Former Auburn coach getting stem cell treatments for Lou Gehrig's disease

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Medistem Receives Notice of Patent Allowance Covering Fat Stem Cell Therapy of Autoimmune Diseases

Friday, June 29th, 2012

SAN DIEGO CA--(Marketwire -06/29/12)- Medistem Inc. (MEDS) announced today notice of allowance from the United States Patent and Trademark Office (USPTO) for a patent covering the use of fat stem cells, and cells associated with fat stem cells for treatment of diseases related to a dysfunctional immune system. Such diseases include multiple sclerosis, Type 1 diabetes, rheumatoid arthritis and lupus. The allowed patent, entitled "Stem Cell Mediated Treg Activation/Expansion for Therapeutic Immune Modulation" has the earliest priority date of December 2006.

"We have previously published that giving multiple sclerosis patients cells extracted from their own fat tissue, which contains stem cells, appears to confer clinical benefit in a pilot study," said Thomas Ichim, CEO of Medistem. "The current patent that has been allowed, in the broadest interpretation of the claims, gives us exclusive rights to the use of specific types of fat stem cell therapy for autoimmune diseases such as multiple sclerosis."

Subsequent to the filing of the patent application, Medistem together with collaborators at the Lawson Health Sciences Research Institute, Canada, reported data that fat tissue contains high numbers of T regulatory cells, a type of immune cell that is capable of controlling autoimmunity.

This finding was independently confirmed by Dr. Diane Mathis' laboratory at Harvard University, who published a paper in the prestigious journal, Nature Medicine, in which detailed experimental evidence was provided supporting the initial finding that adipose tissue contains high numbers of T regulatory cells. A video describing the paper can be accessed at http://www.youtube.com/watch?v=rEJfGu29Rg8.

The current patent discloses the use of T regulatory cells from fat, combinations with stem cells, and use of fat-derived mononuclear cells. Given that there are currently several groups utilizing this technology in the USA in treating patients, Medistem believes revenue can be generated through enforcement of patent rights.

"Our corporate philosophy has been to remain highly focused on our ongoing clinical stage programs using Medistem's universal donor stem cell, the Endometrial Regenerative Cell (ERC), in the treatment of critical limb ischemia and congestive heart failure," said Dr. Vladimir Bogin, Chairman and President of Medistem. "However, due to the ease of implementation of our fat stem cell technology, combined with the major burden that autoimmune diseases have on our health care system, we are highly incentivized to explore partnering, co-development and licensing opportunities."

Autoimmune conditions occur as a result of the body's immune system "turning on itself" and attacking its own organs or cells. Current treatments for autoimmune conditions are based on "globally" suppressing the immune system by administration of immunosuppressive drugs. This is associated with an increased predisposition to infections and significant side effects. The utilization of stem cells and T regulatory cells offers the potential to selectively suppress pathological immunity while preserving the ability of the body to fight bacteria and viruses. According to the NIH there are approximately 23 million victims of autoimmune conditions.

Links to Documents:

Link to peer-reviewed publication: http://www.translational-medicine.com/content/pdf/1479-5876-7-29.pdf

Link: http://www.marketwire.com/press-release/medistem-files-patent-application-on-therapeutic-cell-population-found-in-fat-tissue-frankfurt-s2u-812298.htm

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Medistem Receives Notice of Patent Allowance Covering Fat Stem Cell Therapy of Autoimmune Diseases

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Global Collaboration Enables Stem Cell Therapy to Rehabilitate Tragically Burned 3-Year-Old

Wednesday, June 27th, 2012

Johannesburg, South Africa (PRWEB) June 27, 2012

After three-year-old Isabella Pippie Kruger was burned on over 80% of her body in a tragic accident, her mother was left searching for a viable option to repair her extremely damaged skin and save her life.

The solution came from across the globe in the form of a company called Genzyme in Boston, MA. Genzyme has developed a protocol for cultivating autologous epidural stem cells in order to generate new skin for patients who have suffered extreme skin trauma.

Genzyme was able to graft 41 sheets of new skin that was made of Pippies own genetic material. This was then flown across the world to South Africa, where the procedure of grafting her new skin took place. It was the first time this type of procedure was administered in South Africa.

Global collaboration in the administration of stem cell therapies to treat previously untreatable conditions is accelerating the paradigm shift in the medical community for the treatment of disease, trauma and injury; a shift that is spearheaded by the utilization of autologous stem cells. The use of the patients own stem cells in emerging regenerative therapies eliminates the chance of rejection of the transplanted tissue and the need for immuno-suppression drugs leading to more favorable outcomes.

To learn more about how families can bank their own, valuable stem cells to ensure access to a variety of emerging regenerative treatments and therapies, visit http://www.stemsave.com or call 877-783-6728 (877-StemSave) today.

The future of Regenerative Medicine is now.

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Global Collaboration Enables Stem Cell Therapy to Rehabilitate Tragically Burned 3-Year-Old

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Magnet helps target transplanted iron-loaded cells to key areas of heart

Wednesday, June 27th, 2012

Optimal stem cell therapy delivery to damaged areas of the heart after myocardial infarction has been hampered by inefficient homing of cells to the damaged site. However, using rat models, researchers in France have used a magnet to guide cells loaded with iron oxide nanoparticles to key sites, enhancing the myocardial retention of intravascularly delivered endothelial progenitor cells.

The study is published in a recent issue of Cell Transplantation (21:4), now freely available online.

"Cell therapy is a promising approach to myocardial regeneration and neovascularization, but currently suffers from the inefficient homing of cells after intracavitary infusion," said Dr. Philippe Menasche of the INSERM U633 Laboratory of Surgical Research in Paris. "Our study was aimed at improving and controlling homing by loading human cord-blood-derived endothelial progenitor cells (EPCs) for transplant with iron oxide nanoparticles in order to better position and retain them in the hearts of myocardial-injured test rats by using a subcutaneously implanted magnet."

The researchers found that the cells were sufficiently magnetic to be able to be remotely manipulated by a magnet subsequent to implantation.

According to the researchers, an objective assessment of the technique to enhance the homing of circulating stem cells is the ability to track their fate in vivo. This was accomplished by visualization with MRI.

"We found a good correlation between MRI non-invasive follow-up of the injected cells and immunofluoresence or quantitative PCR data," said Dr. Menasche. The researchers concluded that further studies were needed to follow cell homing at later time points. They noted that the magnitude of homing they experienced may have been reduced by the relatively small number of cells used, owing to their large size and the subsequent risk of coronary thrombosis.

"In a rat model of myocardial infarction, this pilot study suggested homing of circulating stem cells can be improved by magnetic targeting and warrants additional benchwork to confirm the validity of concept," said Dr. Menasche. "There is also a need to optimize the parameters of targeting and assess the relevance of this approach in a clinically relevant large animal model."

"This study highlights the use of magnets to target transplanted cells to specific sites which could increase their regenerative impact. Factors to still be extensively tested include confirming the safety of the cells containing the magnetic particles and whether this process alters the cell's abilities" said Dr. Amit N. Patel, director of cardiovascular regenerative medicine at the University of Utah and section editor for Cell Transplantation.

More information: Chaudeurge, A.; Wilhelm, C.; Chen-Tournoux, A.; Farahmand, P.; Bellamy, V.; Autret, G.; Mnager, C.; Hagge, A.; Larghro, J.; Gazeau, F.; Clment, O.; Menasch, P. Can Magnetic Targeting of Magnetically Labeled Circulating Cells Optimize Intramyocardial Cell Retention? Cell Transplant. 21 (4):679-691; 2012.

Journal reference: Cell Transplantation

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Magnet helps target transplanted iron-loaded cells to key areas of heart

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NeoStem Awarded NIAID Research Grant for the Development of VSEL Technology for Radiation Exposure

Monday, June 25th, 2012

NEW YORK, June 25, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a cell therapy company, today announced that it has been awarded a two year grant totaling $595,252 for the "Development of Human, Autologous, Pluripotent Very Small Embryonic Like (VSELs) Stem Cells as a Countermeasure to Radiation Threat" from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). This peer reviewed grant was awarded to support research to be headed by Denis O. Rodgerson, Ph.D., Director of Stem Cell Science for NeoStem and Mariusz Ratajczak, M.D., Ph.D., who is the head of the Stem Cell Biology Program at the James Graham Brown Cancer Center at the University of Louisville and co-inventor of VSELTM Technology.

This award will fund studies to investigate the potential of very small embryonic-like stem cells as a countermeasure to radiological and nuclear threat. The product candidate, which is an autologous stem cell therapy derived from the patient's own stem cells, will be developed to rescue patients who have been exposed to radiation due to nuclear accident or terrorist threat and to treat cancer patients who have undergone radiation therapy and who consequently have compromised immune systems. The award includes $295,252 for the first year and $300,000 for the second year of the project.

Dr. Denis O. Rodgerson, Director of Stem Cell Science for NeoStem, said, "We are very excited to add radiation treatment to the growing list of indications for which our VSELTM Technology is being evaluated. Those exposed to acute high-dose radiation have compromised immune systems such that the virulence and infectivity of biological agents is dramatically increased. Death can occur within 1-6 weeks following radiation exposure. Currently there is only one intervention that saves a fatally irradiated person -- a rescue through stem cell transplantation. VSELs might be an ideal cell therapy to regenerate the body's immune system and repair other tissues damaged by radiation exposure. Most importantly, early studies show VSELs are resistant to lethal radiation which destroys other immune system restoring stem cells in the body, making autologous treatment post-exposure possible."

Dr. Robin L. Smith, Chairman and CEO of NeoStem, added, "NeoStem is pleased that the NIAID is funding this cutting edge technology that we hope will reinvent the treatment landscape for acute radiation syndrome. We plan to continue to pursue NIH SBIR grants to fund our VSEL technology platform development with non-dilutive capital."

About VSELTM Technology

NeoStem has a worldwide exclusive license to VSELTM Technology. Research by Dr. Mariusz Ratajczak, M.D., Ph.D., and others at the University of Louisville provides compelling evidence that bone marrow contains a heterogeneous population of stem cells that have properties similar to those of an embryonic stem cell. These cells are referred to as very small embryonic-like stem cells. This finding opens the possibility of capturing some of the key advantages associated with embryonic stem cells without the ethical or moral dilemmas and without some of the potential negative biological effects associated with stem cells of embryonic derivation. The possibility of autologous VSEL treatments is yet another important potential benefit to this unique population of adult stem cells. VSELTM Technology offers the potential to go beyond the paracrine effect, yielding cells that actually differentiate into the target tissue creating true cellular regeneration.

About NeoStem, Inc.

NeoStem, Inc. ("we," "NeoStem" or the "Company") continues to develop and build on its core capabilities in cell therapy to capitalize on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a large role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. Our January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") provides NeoStem with a foundation in both manufacturing and regulatory affairs expertise. We believe this expertise, coupled with our existing research capabilities and collaborations, will allow us to achieve our mission of becoming a premier cell therapy company. Our PCT subsidiary's manufacturing base is one of the few current Good Manufacturing Practices ("cGMP") facilities available for contracting in the burgeoning cell therapy industry. Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and Amorcyte is enrolling patients for a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. We also expect to begin a Phase 1 clinical trial by 2012/2013 to investigate AMR-001's utility in arresting the progression of congestive heart failure and the associated comorbidities of that disease. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is engaged in collaboration with Becton-Dickinson that is exploring the earlier stage clinical development of a T-cell therapy for autoimmune conditions. In addition, our pre-clinical assets include our VSELTM Technology platform as well as our MSC (mesenchymal stem cells) product candidate for regenerative medicine.

For more information on NeoStem, please visit http://www.neostem.com.

Forward-Looking Statements

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NeoStem Awarded NIAID Research Grant for the Development of VSEL Technology for Radiation Exposure

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Parsing Geron’s Stem Cell Foray: A Nature Journal Commentary

Sunday, June 24th, 2012


Why did Geron "fail" in its
much ballyhooed pursuit of the first-ever human embryonic stem cell
therapy?

Christopher Scott, senior
research scholar at Stanford, and Brady Huggett,
business editor of the journal Nature, took a crack at
answering that question in a commentary in the June edition of
Nature.
Following the sudden abandonment last
fall by Geron of its hESC business and the first-ever clinical trial
of an hESC therapy, Scott and Huggett scrutinized the history of the
company. The financial numbers were impressive. They wrote,

"How did Geron’s R&D program
meet such a demise? After all, the company raised more than $583
million through 23 financings, including two venture rounds, and
plowed more than half a billion dollars into R&D (about half of
that into hESC work) through 2010. 

"There are problems with being at
the forefront of unknown territory. Of Geron’s development efforts,
the hESC trial was the most prominent, and fraught. Therapies based
on hESCs were new territory for the US Food and Drug
Administration
(FDA), and it eyed Geron warily. The
investigational new drug application (IND), filed in 2008, was twice
put on clinical hold while more animal data were collected among
fears that nonmalignant tumors would result from stray hESCs that
escaped the purification process. Geron says it spent $45 million on
the application, and at 22,000 pages, it was reportedly the largest
the agency had ever received."

The California stem cell agency also
bet $25 million on the company just a few months before it pulled the
plug. Geron repaid all the CIRM money that it had used up to that point.
Geron suffered from a lack of revenue
despite its vaunted stem cell patent portfolio. Scott and Huggett
reported that Geron received only $69 million from 1992 to 2010 from
collaborations, license and royalties. At the same time losses were
huge – $111 million in 2010.
The Nature article noted all of that
was occurring while other biotech companies – such as Isis
and Alnylam – found ample financial support, revenue and
success.
Scott's and Huggett's directed their
final comment to Advanced Cell Technology, now the only
company in the United States with a clinical trial involving a human
embryonic stem cell therapy.

"Your technology may be
revolutionary, your team may be dedicated and you may believe. But it
does not matter if no one else will stand at your side."

Our take: The California stem cell
agency obviously has learned something from its dealings with Geron.
The company's hESC announcement was an unpleasant surprise, to put it
mildly, coming only about three months after CIRM signed the Geron
loan agreement. Today, however, the agency has embarked on more,
equally risky ventures with other biotech enterprises. Indeed, CIRM
is forging into areas that conventional investment shuns. It is all
part of mission approved by California voters in 2004.
The dream of cures from human embryonic
stem cells or even adult stem cells is alluring. And CIRM is feeling
much justifiable pressure to engage industry more closely. All the
more reason for CIRM's executives and directors to maintain a steely
determination to terminate research programs that are spinning their
wheels and instead pursue efforts that are making significant
progress in commercializing research and attracting other investors.  

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

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The California Stem Cell Agency and an HIV Cure: Pushing for a Clinical Trial in 2014

Sunday, June 24th, 2012


The California stem cell agency's
leading efforts to find a cure for HIV – one tied to the famous "Berlin Patient" – received a plug today in a piece in the
state capital's largest circulation newspaper, The Sacramento Bee.

The article by David Lesher focused on
a $14 million CIRM grant to the City of Hope in Los Angeles that also
involves Sangamo BioSciences of Richmond, Ca. The team hopes to
launch a clinical trial by the end of next year.
The Berlin Patient is Timothy Brown,
now of San Francisco, who is the only person in the world known to
have been cured of HIV/AIDs. It came about as a side effect of a
blood transfusion carrying a rare mutation of a gene found almost
entirely among northern Europeans. Lesher, director of governmental
affairs for the Public Policy Institute in Sacramento, wrote,

"The
possibility of curing a global pandemic like AIDS with funding from
the California bond is exactly the kind of exciting potential that
inspired voters to approve Proposition 71
 by
a wide margin. But the HIV research is also a good example of the
challenge facing the state's s
tem cell agency
as it tries to show voters that they made a good investment.
 

None
of the research under way will reach patients until long after the 10
years of funding by the ballot measure runs out. With the HIV
project, researchers hope to be in human trials by 2014, but it is
likely to be at least 10 years before they can show it might work in
humans. And in the case of a stem cell
 cure
for AIDS, it would be many years after that before a treatment is
widely available.”

Jeff
Sheehy
, a prominent AIDS activist and a board member at the 
stem
cell
 agency,
described the effort as "the global home run. That's not in 10
years. … But this could be the beginning of something really
amazing."
Lesher also wrote,

"Nobody
thought stem cells 
might
be used to cure HIV when the bond (funding for the stem cell agency)
passed. Far from the embryonic stem cell 
treatments
that inspired the ballot measure, the HIV research involves a new and
growing integration of stem cell 
and
genetic science."

Indeed,
the ballot initiative that created the $3 billion California stem
cell agency trumpeted its devotion to human embryonic stem cell
research, which had been throttled by the Bush Administration. The
agency has veered away from hESC research, which now amounts
to less than $450 million out of the $1.4 billion in grants approved
since 2004. 

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

Read More...

Parsing Geron’s Stem Cell Foray: A Nature Journal Commentary

Sunday, June 24th, 2012


Why did Geron "fail" in its
much ballyhooed pursuit of the first-ever human embryonic stem cell
therapy?

Christopher Scott, senior
research scholar at Stanford, and Brady Huggett,
business editor of the journal Nature, took a crack at
answering that question in a commentary in the June edition of
Nature.
Following the sudden abandonment last
fall by Geron of its hESC business and the first-ever clinical trial
of an hESC therapy, Scott and Huggett scrutinized the history of the
company. The financial numbers were impressive. They wrote,

"How did Geron’s R&D program
meet such a demise? After all, the company raised more than $583
million through 23 financings, including two venture rounds, and
plowed more than half a billion dollars into R&D (about half of
that into hESC work) through 2010. 

"There are problems with being at
the forefront of unknown territory. Of Geron’s development efforts,
the hESC trial was the most prominent, and fraught. Therapies based
on hESCs were new territory for the US Food and Drug
Administration
(FDA), and it eyed Geron warily. The
investigational new drug application (IND), filed in 2008, was twice
put on clinical hold while more animal data were collected among
fears that nonmalignant tumors would result from stray hESCs that
escaped the purification process. Geron says it spent $45 million on
the application, and at 22,000 pages, it was reportedly the largest
the agency had ever received."

The California stem cell agency also
bet $25 million on the company just a few months before it pulled the
plug. Geron repaid all the CIRM money that it had used up to that point.
Geron suffered from a lack of revenue
despite its vaunted stem cell patent portfolio. Scott and Huggett
reported that Geron received only $69 million from 1992 to 2010 from
collaborations, license and royalties. At the same time losses were
huge – $111 million in 2010.
The Nature article noted all of that
was occurring while other biotech companies – such as Isis
and Alnylam – found ample financial support, revenue and
success.
Scott's and Huggett's directed their
final comment to Advanced Cell Technology, now the only
company in the United States with a clinical trial involving a human
embryonic stem cell therapy.

"Your technology may be
revolutionary, your team may be dedicated and you may believe. But it
does not matter if no one else will stand at your side."

Our take: The California stem cell
agency obviously has learned something from its dealings with Geron.
The company's hESC announcement was an unpleasant surprise, to put it
mildly, coming only about three months after CIRM signed the Geron
loan agreement. Today, however, the agency has embarked on more,
equally risky ventures with other biotech enterprises. Indeed, CIRM
is forging into areas that conventional investment shuns. It is all
part of mission approved by California voters in 2004.
The dream of cures from human embryonic
stem cells or even adult stem cells is alluring. And CIRM is feeling
much justifiable pressure to engage industry more closely. All the
more reason for CIRM's executives and directors to maintain a steely
determination to terminate research programs that are spinning their
wheels and instead pursue efforts that are making significant
progress in commercializing research and attracting other investors.  

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

Read More...

The California Stem Cell Agency and an HIV Cure: Pushing for a Clinical Trial in 2014

Sunday, June 24th, 2012


The California stem cell agency's
leading efforts to find a cure for HIV – one tied to the famous "Berlin Patient" – received a plug today in a piece in the
state capital's largest circulation newspaper, The Sacramento Bee.

The article by David Lesher focused on
a $14 million CIRM grant to the City of Hope in Los Angeles that also
involves Sangamo BioSciences of Richmond, Ca. The team hopes to
launch a clinical trial by the end of next year.
The Berlin Patient is Timothy Brown,
now of San Francisco, who is the only person in the world known to
have been cured of HIV/AIDs. It came about as a side effect of a
blood transfusion carrying a rare mutation of a gene found almost
entirely among northern Europeans. Lesher, director of governmental
affairs for the Public Policy Institute in Sacramento, wrote,

"The
possibility of curing a global pandemic like AIDS with funding from
the California bond is exactly the kind of exciting potential that
inspired voters to approve Proposition 71
 by
a wide margin. But the HIV research is also a good example of the
challenge facing the state's s
tem cell agency
as it tries to show voters that they made a good investment.
 

None
of the research under way will reach patients until long after the 10
years of funding by the ballot measure runs out. With the HIV
project, researchers hope to be in human trials by 2014, but it is
likely to be at least 10 years before they can show it might work in
humans. And in the case of a stem cell
 cure
for AIDS, it would be many years after that before a treatment is
widely available.”

Jeff
Sheehy
, a prominent AIDS activist and a board member at the 
stem
cell
 agency,
described the effort as "the global home run. That's not in 10
years. … But this could be the beginning of something really
amazing."
Lesher also wrote,

"Nobody
thought stem cells 
might
be used to cure HIV when the bond (funding for the stem cell agency)
passed. Far from the embryonic stem cell 
treatments
that inspired the ballot measure, the HIV research involves a new and
growing integration of stem cell 
and
genetic science."

Indeed,
the ballot initiative that created the $3 billion California stem
cell agency trumpeted its devotion to human embryonic stem cell
research, which had been throttled by the Bush Administration. The
agency has veered away from hESC research, which now amounts
to less than $450 million out of the $1.4 billion in grants approved
since 2004. 

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

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Stem cell therapy gives dog new lease on life

Friday, June 22nd, 2012

Stem cell therapy has gone to the dogs. The technology aimed at giving ailing pets a new lease on life has arrived in Hawaii.

13-year-old Kumba is still a bit dazed, coming out of general anesthesia. The veterinarian at Surf Paws Animal Hospital just extracted about two tablespoons of fat tissue from the dog. Stem cells from that fat tissue will then be used to help him with his arthritis.

"Once we get the stem cells then we do some extra processing steps to wake them up so that they're very active. At the end of that, the veterinarian will inject the stem cells into the areas of damage," says Carol Spangler Vaughn of Medivet America.

A company called MediVet America is bringing the technology to animal hospitals in Hawaii. This is a first for Oahu. The company says the procedure works on other animals with different types of ailments.

"So the nice thing about this we're not gonna give you a puppy back but we'll give you some nice quality time with your animal. You won't have to put them down because of their arthritis," Vaughn said.

Kumba's arthritis had gotten worse in the past five years, and his owners were wondering whether it was best to end his life to stop him from suffering.

'When we start saying things like oh we don't know how much longer, poor Kumba, he must be in a lot of pain. That kind of stuff really hits home especially since he's been with us for so long," said Rumi Hospodar Kumba's owner.

But with this new procedure, they're counting on Kumba to be pain free in a few weeks and are looking forward to get backdoing some of the things Kumba enjoyed, like swimming.

"He can't do that now since his joints are so bad, and he's getting so old so that's one of the many things I'm looking forward to," Kelsea Hopsodar, his other owner said.

The cost of the procedure runs from 24 to 28 hundred dollars, and it's covered by most pet insurance policies.

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Stem cell therapy gives dog new lease on life

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Stem cell therapy in Hawaii going to the dogs

Friday, June 22nd, 2012

HAWAII KAI (HawaiiNewsNow) -

Cutting-edge technology is helping Hawaii's pets live better lives for months, even years. We were there as a beloved dog named Kumba received one of the first-ever, in-clinic stem cell therapy surgeries in the islands.

13 year old Kumba doesn't know he's a guinea pig. The Rottweiler-Lab mix is one of the first in Hawaii to undergo the stem cell procedure at Surf Paws in Hawaii Kai.

Kumba suffers severe arthritis in his hips and knees, doesn't eat much, and is even a bit depressed. "It's an effort for him to get up off the floor, and when he gets up and crosses the room, you can see the stiffness," says his owner, Rumi Hospodar.

Kumba's kids learn some of details of his surgery. Then, he's moved to a table and nods off from anesthesia. Once he's prepped, the procedure begins. The vet removes about two tablespoons of fat tissue from Kumba's shoulder. From there, the stem cells are separated from the fat and activated. Then, they're injected back into the affected areas.

The entire process takes four hours, but the dog is actually only under for about 20 minutes. Surf Paws used to send the tissue to the mainland for processing, but with technology from Medi-Vet America, they can do it all here.

"The patient had to be, you know, go home and come back a few days later and the timing was a little bit difficult. Now, everything is same day," says Surf Paws veterinarian Dr. Cristina Miliaresis.

Cost depends on the size of animal but can run up to $2,800. It's mainly done on dogs, cats, and horses who suffer osteoarthritis, hip dysplasia, ligament and cartilage damage, and other degenerative diseases. Their quality of life can improve within a couple of weeks.

Dr. Miliaresis says, "Some people might say, 'Oh, the dog's 13. Why are you doing this for a 13 year old dog? But even 6 months, pain-free, after a very, it's not simple, but it's a pretty straightforward procedure, to me (would be) just amazing."

The techs move all 97 pounds of Kumba to post-op - while his anxious owner looks on.

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Stem cell therapy in Hawaii going to the dogs

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Cryo-Save Group N.V. awards researcher at grand opening of its new headquarters

Thursday, June 21st, 2012

The leading international family stem cell bank, Cryo-Save, celebrates the grand opening of its brand new headquarters office in Zutphen, the Netherlands, by honoring PhD. T.H.J. Nijhuis with the Young Investigator Award on June 22nd.

Cryo-Save`s headquarters, located in Zutphen, the Netherlands, is celebrating the grand opening of its brand new, fully-renovated headquarters. On June 22nd, Arnoud van Tulder, CEO of Cryo-Save, and attorney-at-law C. Bieze, deputy in the province of Gelderland, will officially open the company`s new global headquarters office.

To mark the occasion, the company will grant PhD. T.H.J. Nijhuis, winner of the Cryo-Save Young Investigator Award, a prize of 5,000 euros. Mr. Nijhuis has focused his most recent research on umbilical cord mesenchymal stem cells and pursues his work at the Erasmus Medical Center, part of the Erasmus University of Rotterdam, the Netherlands.

Arnoud van Tulder, CEO of Cryo-Save, says "We are proud to name Mr. T.H.J. Nijhuis, as the winner of the Cryo-Save Young Investigator Award. Research is a cornerstone of the stem cell industry, and it`s advancements like that of Mr. T.H.J. Nijhuis that makes us so optimistic for the future."

As part of Cryo-Save`s educational and community outreach efforts, the Cryo-Save Young Investigator Award is yet another example of how the company supports the advancement of stem cell use in the medical field. Cryo-Save seeks to improve and expand stem cell knowledge among the general public and professional health community, as they see in stem cell therapy a huge potential in the treatment of various diseases.

More information:

Ccile Kastler - Communications Manager

cecile.kastler@cryo-save.com - tel. +41-(0) 79 827 80 98

Cryo-Save: http://www.cryo-save.com/group

Cryo-Save, the leading international family stem cell bank, stores more than 200,000 samples from umbilical cord blood, cord tissue and adipose tissue. There are already many diseases treatable by the use of stem cells, and the number of treatments will only increase. Driven by its international business strategy, Cryo-Save is now represented in over 40 countries on 3 continents, with ultra-modern processing and storage facilities in Belgium, Germany, Dubai, India and South Africa.

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Cryo-Save Group N.V. awards researcher at grand opening of its new headquarters

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Sixteenth Patient Dosed In Neuralstem ALS Stem Cell Trial

Tuesday, June 19th, 2012

ROCKVILLE, Md., June 19, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that the first patient to receive stem cell transplantation in both regions of the spinal cord has been treated in the ongoing Phase I trial of its spinal cord neural stem cells in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). This is also the 16th patient to be treated in the trial altogether and the first patient returning to the trial for a second treatment. In this treatment, the patient received five injections in the cervical (upper back) region of the spinal cord, in addition to the ten he received previously in the lumbar (lower back) region of the spine, for a total of 15 injections. This is the highest number of injections in the trial so far. Patient 16 is also the first patient in the world to receive stem cell transplants in both the lumbar and cervical regions of the spinal cord in an FDA-approved trial. Two additional previously-treated patients are expected to return to the trial this summer in this cohort, provided they continue to meet the inclusion requirements. The trial is taking place at Emory University Hospital in Atlanta, Georgia.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

"Transplanting the first of the returning patients represents a major milestone in the trial," said Dr. Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer. "The ability to safely administer multiple dosings to these patients is a key enabling step in administering the maximum safe dose. Not only are we dosing patients for a second time in this cohort, we are now dosing in both the lumbar and cervical regions of the spinal cord for the first time, where the stem cell therapy could support both walking and breathing."

About the Trial

The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The trial is designed to enroll up to 18 patients. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts.

The trial then advanced to transplantation in the cervical (upper back) region of the spine. The first cohort of three was treated in the cervical region only. The current cohort of three will receive injections in both the cervical and lumbar regions of the spinal cord. In an amendment to the trial design, The Food and Drug Administration (FDA) approved the return of previously-treated patients to this cohort. The first of these returning patients was just treated. The entire 18-patient trial concludes six months after the final surgery.

About Neuralstem

Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has received approval from the FDA to conduct a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include CTE (chronic traumatic encephalopathy), Alzheimer's disease, anxiety, and memory disorders.

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Sixteenth Patient Dosed In Neuralstem ALS Stem Cell Trial

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Animal Stem Cell Therapy

Tuesday, June 19th, 2012

BYRON, MN--It's a dream for many in the medical field, to use a person's own stem cells to help them heal. And it's a reality already happening in our area.

But it's not humans who are being treated. In this case, dogs are the ones being treated.

Animal Stem Cell Regenerative Therapy has been performed a few thousand times now across the U.S. Doctors harvest stem cells and re-enter them where the animal is having problems.

Both Marley and Vinnie have bad ligaments in their legs, and like many dogs suffering from arthritis, they are subject to monthly doses of expensive drugs.

That is until today.

Dr. Garren Kelly, D.V.M. at Meadow View Veterinary Clinic just outside Rochester says, "If you'd of asked me 5 years ago if I would be doing anything like this, I would have said no. But then as soon as I saw it i'm like 'Yeah that's for me'. I kind of like staying on the cutting edge of technology and surgeries".

The two are undergoing a first of its kind surgery in minnesota, using regenerative stem cells.

Blood is taken from the dogs, as well as fat tissue.

Then stem cells are separated out from the fat, activated with an led light, and injected back into the affected area. All in the same day.

MediVet America trainer Jordan Smith says, "It's a better quality of life, we're not promising to give them 10 years or 5 years but we are promising that the years that they do have remaining are a lot more enjoyable".

More:
Animal Stem Cell Therapy

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Another Nod for Osiris' Prochymal

Tuesday, June 19th, 2012

Just a few weeks after gaining approval in Canada, Osiris Therapeutics, Inc.s (OSIR) stem cell therapy, Prochymal, gained approval in New Zealand. Prochymal gained approval for the treatment of acute graft-vs-host disease (GvHD) in children.

Osiris had submitted its marketing application to Medsafe, the medical regulatory agency in New Zealand, in May 2011. Prochymal was granted priority review status.

Prochymal is the first manufactured stem cell product to gain approval and the first treatment to gain approval for GvHD.

Besides being approved in Canada and New Zealand, we note that Prochymal is available under an Expanded Access Program (:EAP) in seven countries including the US.

Our Take

Prochymals approval in New Zealand is a boost for Osiris. Shares were up 13.75% on the news. Prochymal is the lead candidate at Osiris and represents significant commercial potential. Prochymal is currently being evaluated for other indications as well including refractory Crohns disease (phase III), type I diabetes, and myocardial infarction (heart attack phase II).

We currently have low visibility on the status of Osiris development and commercialization agreement with Genzyme, a Sanofi (SNY) company, for Prochymal. Earlier this year, Sanofi, in its fourth quarter press release, had said that it has discontinued the development of Prochymal for GvHD.

Osiris said that the announcement was made without its knowledge or advice and clarified that Prochymals development has not been discontinued. Although Osiris had not received any communication from Sanofi regarding the termination of their agreement, Osiris notified Sanofi that it is treating Sanofis statement as an intention to terminate the agreement.

According to Osiris, all rights to Prochymal will return to Osiris without the company being required to compensate Sanofi. Osiris believes it can now pursue commercialization agreements for Prochymal with other parties.

We currently have a Neutral recommendation on Osiris, which carries a Zacks #3 Rank (short-term Hold rating).

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Another Nod for Osiris' Prochymal

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Another Nod for Osiris' Prochymal – Analyst Blog

Tuesday, June 19th, 2012

Referenced Stocks: OSIR, SNY

Just a few weeks after gaining approval in Canada, Osiris Therapeutics, Inc.'s ( OSIR ) stem cell therapy, Prochymal, gained approval in New Zealand. Prochymal gained approval for the treatment of acute graft-vs-host disease (GvHD) in children.

Osiris had submitted its marketing application to Medsafe, the medical regulatory agency in New Zealand, in May 2011. Prochymal was granted priority review status.

Prochymal is the first manufactured stem cell product to gain approval and the first treatment to gain approval for GvHD.

Besides being approved in Canada and New Zealand, we note that Prochymal is available under an Expanded Access Program (EAP) in seven countries including the US.

Our Take

Prochymal's approval in New Zealand is a boost for Osiris. Shares were up 13.75% on the news. Prochymal is the lead candidate at Osiris and represents significant commercial potential. Prochymal is currently being evaluated for other indications as well including refractory Crohn's disease (phase III), type I diabetes, and myocardial infarction (heart attack - phase II).

We currently have low visibility on the status of Osiris' development and commercialization agreement with Genzyme, a Sanofi ( SNY ) company, for Prochymal. Earlier this year, Sanofi, in its fourth quarter press release, had said that it has discontinued the development of Prochymal for GvHD.

Osiris said that the announcement was made without its knowledge or advice and clarified that Prochymal's development has not been discontinued. Although Osiris had not received any communication from Sanofi regarding the termination of their agreement, Osiris notified Sanofi that it is treating Sanofi's statement as an intention to terminate the agreement.

According to Osiris, all rights to Prochymal will return to Osiris without the company being required to compensate Sanofi. Osiris believes it can now pursue commercialization agreements for Prochymal with other parties.

Follow this link:
Another Nod for Osiris' Prochymal - Analyst Blog

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Sistemic to Moderate Regenerative Medicine Panel at 2012 Bio International Convention

Monday, June 18th, 2012

BOSTON--(BUSINESS WIRE)--

Sistemic Ltd., a leading provider of microRNA-based problem-solving services and kit-based products to the Cell Therapy community, announced today that chairman and CEO Jim Reid is moderating a panel discussion at the 2012 Bio International Convention on Wednesday, June 20, in Boston. Featuring leaders from the regenerative medicine space, the panel is titled Stem Cell Therapies Fact or Fiction, and will share the lessons learned to-date from Scottish, European and American perspectives on the path to successfulcommercialization of stem cell therapies.

Jim Reid, Sistemic CEO, commented, "Sistemic is very active in the CellTherapyarena and aremembersof Alliance for Advanced Therapies (AAT) and the Alliance for Regenerative Medicine (ARM). We see the ability to raise this topic at the leading world event, BIO 2012, as animportantstep on the path to commercialization of these products which will be transformational in healthcare, and bring hope and cures to many people around the globe."

More information on the panel at BIO 2012:

What: Panel Discussion Featuring Leaders in the Regenerative Medicine Space

When: Wednesday, June 20, 3:00PM EDT

Where: Boston Convention Center, Room 254A

Who: Leaders of the Regenerative Medicine space:

Panel objectives include evaluating lessons learned and best practice including from the Scotland Roadmap for the commercialization of stem cell therapies; identifying global (US and EU) examples of progress in stem cell therapy commercialization; and facilitating a debate on the need for a global, multi-disciplinary approach to successful commercialization of stem cell therapies.

About Sistemic Ltd

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Sistemic to Moderate Regenerative Medicine Panel at 2012 Bio International Convention

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Royal Oak Veterinarian Dr. Simon First in Michigan to Offer In-House Adult Pet Stem Cell Therapy

Monday, June 18th, 2012

ROYAL OAK, Mich., June 17, 2012 (GLOBE NEWSWIRE) -- Woodside Animal Hospital announced they have added both stem cell therapy and cold laser therapy to their suite of services. These two cutting edge treatments are done entirely in-house, no third-party lab work is required. Royal Oak veterinarian Dr. John Simon is the first Michigan veterinarian to provide pets with in-house adult stem cell therapy. The stem cells are derived from the pet's fat deposits and absolutely no embryonic tissue is used.

"As a holistic veterinarian, I am committed to providing high quality, cutting-edge care that combines traditional veterinary care with advanced holistic treatments," said Dr. Simon. "Our in-house stem cell therapy and cold laser therapy procedures alleviate pain in limping dogs and promote internal healing following an injury. I also recommend these procedures for pets with osteoarthritis."

Cold laser therapy is a non-surgical approach to pain management. Holistic equine veterinarians have used the procedure for over 20 years to treat injuries and joint pain. Today, veterinarians are using cold laser therapy to provide natural pain relief for injured pets.

According to Dr. Simon, cold laser therapy works by using a low-level energy beam to penetrate just below the skin's surface. Injured cells use the laser's energy to repair cellular damage. This provides relief for pain and swelling following a soft tissue injury, such as a ligament, tendon or muscle strain.

"Cold laser therapy is a revolutionary treatment for natural pain management in animals," said the Royal Oak veterinarian. "Laser therapy allows for advanced pain management, especially for pets suffering from chronic conditions or soft tissue injuries."

Woodside Animal Hospital also provides in-house pet stem cell therapy. This treatment uses adult stem cells collected from a dog's fat deposits to promote the growth of new soft tissue and cartilage. By performing the whole procedure in the clinic, the stem cells can be harvested and re-injected on the same day.

"Our in-house pet stem cell therapy is an affordable, same-day treatment that helps dogs suffering from joint pain, osteoarthritis, soft tissue injuries and hip dysplasia," said Dr. Simon. "As pets age, it's natural that their range of movement becomes restricted. While oral joint care supplements and prescription painkillers can help, medication alone cannot restore a full range of movement. Our treatments help restore activity and movement."

In addition to cold laser therapy and stem cell therapy, Dr. Simon also provides holistic treatments for cancer in dogs, cat and dog rashes, and dietary needs. The Royal Oak practice is a full-service animal hospital with wellness care, vaccinations and surgical procedures.

Dr. Simon is active in the greater Detroit veterinary community, serving as the past president of the Oakland County Veterinary Medical Association and as a board member for the Southeastern Michigan Veterinary Medical Association (SEMVMA).

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Royal Oak Veterinarian Dr. Simon First in Michigan to Offer In-House Adult Pet Stem Cell Therapy

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