StemCell Therapy

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

"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."

"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."

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

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
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 stem 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.”

"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."

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

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.

See more here:
Stem cell therapy gives dog new lease on life

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.

Go here to read the rest:
Stem cell therapy in Hawaii going to the dogs

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.

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

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.

Follow this link:
Sixteenth Patient Dosed In Neuralstem ALS Stem Cell Trial

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

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).

Read the rest here:
Another Nod for Osiris' Prochymal

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

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

See the original post here:
Sistemic to Moderate Regenerative Medicine Panel at 2012 Bio International Convention

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).

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

The California stem cell agency is
considering adding more cash to its upcoming $30 million award round
aimed at aiding projects that can complete – within the next four
years – a clinical trial for a therapy.

“The Strategic Partnership Funding
Program represents a new era for CIRM, one that is increasingly
focused on moving therapies from the lab to the clinic, while still
recognizing the importance of maintaining investments in early stage
science,”

"We received 37 letters of intent
(LOIs), including 8 from non-profits and 29 from biotech companies.
 Based on the information in the LOIs, and on discussions with
applicants, we were able to determine that some of the proposals were
for projects that were outside the scientific scope of the RFA and
that some of the applicants did not meet the minimum specified
criteria in the RFA for 'Commercial Validation.' We currently expect
to receive 10-15 applications for projects that appear to be
eligible."

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

Jill Helms, Stanford photo

Zhenyu Tang (at microscope) examines vascular stem cells in culture along with Aijun Wang (left) and Song Li. UC Berkeley/Zoey Huang photo

"Even though he works just across
the (San Francisco) Bay from me - I met him at a meeting in Japan
that was sponsored by the California Institute for Regenerative
Medicine, or CIRM, and they fund a lot of stem cell research in
California."

"I will tell you that cancer is
certainly a disease that looks very much like a stem cell gone out of
control. And so if we understand what normally regulates a stem
cell's behavior, then we gain some crucial insights into what
regulates maybe a cancer cell's behavior. It's that kind of approach
that I think that CIRM is largely funding initiatives to try to
target human diseases, the big ones, and the ones that make us all
sort of quake in our shoes, and attempt to come up with new
therapies."

"Most basic scientists that work
in stem cells and in the area of stem cell are trying as hard as
possible to move this into translational therapies, things that can
be used in humans. And, of course, CIRM, our funding institution, is
very adamant about this being the trajectory. So, you know, I'll be
taking a stab at it about five to seven years. I think that the
ability to rapidly screen existing drugs for their ability to target
this cell population is why we think that it might have a shorter
course to getting into humans."

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

The California stem cell agency is
considering adding more cash to its upcoming $30 million award round
aimed at aiding projects that can complete – within the next four
years – a clinical trial for a therapy.

“The Strategic Partnership Funding
Program represents a new era for CIRM, one that is increasingly
focused on moving therapies from the lab to the clinic, while still
recognizing the importance of maintaining investments in early stage
science,”

"We received 37 letters of intent
(LOIs), including 8 from non-profits and 29 from biotech companies.
 Based on the information in the LOIs, and on discussions with
applicants, we were able to determine that some of the proposals were
for projects that were outside the scientific scope of the RFA and
that some of the applicants did not meet the minimum specified
criteria in the RFA for 'Commercial Validation.' We currently expect
to receive 10-15 applications for projects that appear to be
eligible."

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

Jill Helms, Stanford photo

Zhenyu Tang (at microscope) examines vascular stem cells in culture along with Aijun Wang (left) and Song Li. UC Berkeley/Zoey Huang photo

"Even though he works just across
the (San Francisco) Bay from me - I met him at a meeting in Japan
that was sponsored by the California Institute for Regenerative
Medicine, or CIRM, and they fund a lot of stem cell research in
California."

"I will tell you that cancer is
certainly a disease that looks very much like a stem cell gone out of
control. And so if we understand what normally regulates a stem
cell's behavior, then we gain some crucial insights into what
regulates maybe a cancer cell's behavior. It's that kind of approach
that I think that CIRM is largely funding initiatives to try to
target human diseases, the big ones, and the ones that make us all
sort of quake in our shoes, and attempt to come up with new
therapies."

"Most basic scientists that work
in stem cells and in the area of stem cell are trying as hard as
possible to move this into translational therapies, things that can
be used in humans. And, of course, CIRM, our funding institution, is
very adamant about this being the trajectory. So, you know, I'll be
taking a stab at it about five to seven years. I think that the
ability to rapidly screen existing drugs for their ability to target
this cell population is why we think that it might have a shorter
course to getting into humans."

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

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Posted June 14, 2012

COLUMBIA, Md. --Osiris Therapeutics, Inc.(NASDAQ: OSIR) has received consent from New Zealand to market its first-in-class stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. New Zealand joins Canada, which last month became the world's first internationally recognized regulatory authority to grant approval to a stem cell drug. Prochymal is also the first therapy approved for GvHD - a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.

"With each of our approvals it becomes clearer that the time for life-saving stem cell therapies in the practice of medicine has arrived, and we are humbled to have a leading role," saidC. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. "I would like to thank the professionals at Medsafe for their thoughtful and expeditious review of this complex application. I would also like to thank the team at Osiris that continues to do an outstanding job of making Prochymal available to children around the world suffering from the devastating effects of GvHD."

Osiris submitted a New Medicine Application to Medsafe (New Zealand's medical regulatory agency) in May of 2011, and was granted Priority Review in June of 2011. Priority review provides expedited review for new drugs which offer a significant clinical advantage over current treatment options. Prochymal was granted provisional consent under Section 23 of the Medicines Act 1981.

"The incidence of GvHD is likely to rise as the demographic profile of our transplant population evolves," saidHans Klingemann,M.D., Ph.D., a Professor of Medicine and the Director of the Bone Marrow & Hematopoietic Stem Cell Transplant Program at Tufts University School of Medicine. "Effective strategies to manage the often lethal consequences of GvHD reduce the overall risk to transplantation and provide the transplant physician with better options when approaching their most difficult cases."

Clinical trials have shown that Prochymal is able to induce an objective, clinically meaningful response in 61-64 percent of children with GvHD that is otherwise refractory to treatment. Furthermore, treatment response with Prochymal resulted in a statistically significant improvement in survival.

"As a mother who watched my son Christian suffer and die from the horrifying effects of GvHD, while waiting for the regulatory approvals necessary to allow him access to Prochymal, words cannot express how happy I am that significant progress is finally being made," saidSandy Barker,President and Co-founder of the Gold Rush Cure Foundation. "We are proud to stand side-by-side with Osiris in this historic battle for our children around the world. Our motto is 'not one more child, not one more family' and when it comes to GvHD mortality, zero is the only acceptable number."

Prochymal is now approved in Canada and New Zealand, and is currently available in seven other countries including the United States under an Expanded Access Program (EAP). It is expected that Prochymal will be commercially available in New Zealand later this year.

Osiris Therapeutics, Inc. is a stem cell company, having developed the world's first approved stem cell drug, Prochymal. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 48 U.S. and 144 foreign issued patents.

Read the original post:
Osiris Receives Second Approval for Stem Cell Drug

ReNeuron Group (Berlin: RQE.BE - news) plc

(the "Company")

Interim data from clinical trial of ReNeuron's stem cell therapy for stroke to be presented at leading scientific conference

Data show no safety concerns and evidence of sustained reductions in neurological impairment and spasticity

Guildford, UK, 14 June 2012: ReNeuron Group plc (the "Company") (LSE: RENE.L) is pleased to announce the presentation of interim data from the PISCES (Pilot Investigation of Stem Cells in Stroke) clinical trial of its ReN001 stem cell therapy for disabled stroke patients. In this open label, dose-ranging Phase I safety study, ReNeuron's ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.

The primary aim of the study is to test the safety and tolerability of the treatment in ascending doses of the ReN001 cells, in patients with moderate to severe functional neurological impairments resulting from their stroke. The secondary aim of the study is to evaluate efficacy measures for the design of future clinical trials with ReN001, including imaging measures as well as a number of tests of sensory, motor and cognitive functions.

To date, six patients have been treated in the PISCES stroke study, representing the first two of four dose cohorts. The interim data being presented are from the first five patients treated, at 2 x 12 month, 1 x six month and 2 x three month follow-up points.

No cell-related adverse events or adverse immune-related responses were reported in any of the patients treated to date. A number of the patients experienced minor procedure-related adverse events such as asymptomatic bleeds or superficial scalp infections at the implantation wound site.

Reductions in neurological impairment and spasticity were observed in all five patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.

Neurological deficits were measured using the National Institutes of Health Stroke Scale (NIHSS), a higher score representing a worse deficit. Patients are required to have a NIHSS score of at least 6 to participate in the study. The pre-treatment median score for the first five patients was 8 (range 6 to 10) and the three month post-treatment median score was 4 (range 3 to 9).

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ReNeuron Group plc - PISCES Trial Interim Data

14 June 2012 Last updated at 07:25 ET By Eleanor Bradford BBC Scotland Health Correspondent

The first patients to take part in a clinical trial of a stem cell treatment for stroke have seen reductions in their disability, according to doctors.

Six patients in the west of Scotland had human stem cells inserted close to the damaged part of their brain.

After receiving the treatment, they saw improvements in the limb weakness they suffered as a result of their stroke.

Howeve, doctors have cautioned against reading too much into the early results of the clinical trial.

It is the world's first trial of a neural stem cell therapy for stroke.

Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.

The trial is being conducted at the Institute of Neurological Sciences at the Southern General Hospital in Glasgow, and is being led by Glasgow University neurologist Professor Keith Muir.

He said: "So far we've seen no evidence of any harmful effects. We're dealing with a group of people a long time after a stroke with significant disability and we don't really expect these patients to show any change over time.

"So it's interesting to see that in all the patients so far they have improved slightly over the course of their involvement in the study."

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Stem cells 'help' stroke patients

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (OSIR), announced today it has received consent from New Zealand to market its first-in-class stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. With this decision New Zealand joins Canada, which last month became the worlds first internationally recognized regulatory authority to grant approval to a stem cell drug. Prochymal is also the first therapy approved for GvHD - a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.

"With each of our approvals it becomes clearer that the time for life-saving stem cell therapies in the practice of medicine has arrived, and we are humbled to have a leading role, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. I would like to thank the professionals at Medsafe for their thoughtful and expeditious review of this complex application. I would also like to thank the team at Osiris that continues to do an outstanding job of making Prochymal available to children around the world suffering from the devastating effects of GvHD."

Osiris submitted a New Medicine Application (NMA) to Medsafe(New Zealand's medical regulatory agency) in May of 2011, and was granted Priority Review in June of 2011. Priority review provides expedited review for new drugs which offer a significant clinical advantage over current treatment options. Prochymal was granted provisional consent under Section 23 of the Medicines Act 1981.

"The incidence of GvHD is likely to rise as the demographic profile of our transplant population evolves," said Hans Klingemann, M.D., Ph.D., a Professor of Medicine and the Director of the Bone Marrow & Hematopoietic Stem Cell Transplant Program at Tufts University School of Medicine. "Effective strategies to manage the often lethal consequences of GvHD reduce the overall risk to transplantation and provide the transplant physician with better options when approaching their most difficult cases.

Clinical trials have shown that Prochymal is able to induce an objective, clinically meaningful response in 61-64 percent of children with GvHD that is otherwise refractory to treatment. Furthermore, treatment response with Prochymal resulted in a statistically significant improvement in survival.

As a mother who watched my son Christian suffer and die from the horrifying effects of GvHD, while waiting for the regulatory approvals necessary to allow him access to Prochymal, words cannot express how happy I am that significant progress is finally being made, said Sandy Barker, President and Co-founder of the Gold Rush Cure Foundation. We are proud to stand side-by-side with Osiris in this historic battle for our children around the world. Our motto is 'not one more child, not one more family' and when it comes to GvHD mortality, zero is the only acceptable number.

Prochymal is now approved in Canada and New Zealand, and is currently available in seven other countries including the United States under an Expanded Access Program (EAP). It is expected that Prochymal will be commercially available in New Zealand later this year.

About GvHD

GvHD represents a major unmet medical need with no approved treatment until Prochymal. GvHD is the leading cause of transplant related mortality, in which immune cells contained within the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Severe GvHD can cause blistering of the skin, intestinal hemorrhage and liver failure. Severe GvHD is extremely painful and fatal in up to 80 percent of cases. Currently, steroids are used as first-line therapy with a success rate of only 30-50 percent. When steroids fail, treatment options are limited to immunosuppressive agents used off-label with little benefit and significant toxicities.

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Osiris Receives Second Approval for Life-Saving Stem Cell Drug; Prochymal Granted Marketing Consent by New Zealand

MANILA, Philippines -- "The Buzz" host Boy Abunda is going to Europe this weekend with his mother, who is suffering from dementia and Alzeimers disease.

In an interview with ABS-CBN News on Tuesday afternoon, Abunda said he will bring his mother to Germany to try stem cell therapy.

"Ako ay pupunta sa Europe hindi para magbakasyon. Dadalhin ko po ang aking ina para magpagamot sa Germany. Ito po 'yung fresh stem cell therapy. Maganda 'yung dini-diretso na dahil napag-uusapan ito," Abunda said.

While Abunda is in Germany, Kris Aquino will take his place on ABS-CBN's entertainment talk show "The Buzz."

In the interview, Abunda also said he's proud of Aquino, who's now open to doing extreme adventures, while continuing to be a good mother to her two sons.

"Ang daming nagbago kay Kris. May mga bagay na hindi ko inakala na gagawin ni Kris like 'yung diving, zipline at marami pang iba. Natutuwa ako that she has become more open to many things. She has become more adventurous. She has retained being the doting mother that she is pero mas malalim ang halakhak niya ngayon sa buhay. She's just so joyful. Natutuwa ako habang pinapanood ko ang kanyang adventure sa 'KrisTV,'" Abunda said.

Abunda said he's also hoping to do a new project with Aquino.

"I'm hoping na someday ay muli kaming magtagpo sa isang palabas dahil marami ang humihiling na kami ay magsama sa isang palabas. Sigurado ako sa puso ko na kami ay gagawa at gagawa dahil magkadugtong ang aming pusod," he said.

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Abunda to try stem cell therapy for mom