Archive for July, 2010|Monthly archive page

FDA OKs First Embryonic Stem Cell Research Trial on Humans, Despite Concerns

In STEM CELLS IN THE NEWS on July 31, 2010 at 3:09 pm

Admiral Horatio Nelson was blinded in one eye early in his Royal Navy career. In 1801, during the Battle of Copenhagen cautious Admiral Sir Hyde Parker, in overall command of the British forces, sent a signal to Nelsons forces giving him discretion to withdraw. Naval orders were transmitted via a system of signal flags at that time. When this order was given to the more aggressive Nelson’s attention, he lifted his telescope up to his blind eye, said “I really do not see the signal”, and his forces continued to press home the attack.

The idiom,

“turning a blind eye,”

is used to describe the process of ignoring unpopular orders or inconvenient facts or activities.




1.  Most of the standard preclinical trial process

  • Preclinical testing – When a drug is discovered that seems to have medical potential, a drug company will test it exhaustively in animals, looking for signs it may be poisonous, cause cancer, or cause birth defects. Animal studies will also be used to estimate the initial drug doses to be tested in humans.When animal experiments are finished, the company asks the FDA for permission to begin clinical trials. The FDA only grants approval once they are satisfied that the animal experiments are sound and that clinical trials are likely to be safe. from

2.  Adult stem cells have successfully treated spinal cord injuryfor years (successfully!

3.  Embryonic stem cell treatments often cause cysts and tumors.  All embryonic scientists and even Geron have openly admitted this.

4.  Embryonic stem cell treatment rejection problems and the immunosuppressive drugs required tooffset them

  • Oh, well…What do spinal cord injury patients need with a healthy immune system when they are trying to get better anyway?

P.S. And by the way, please note that every single one of these issues is scientific; not moral, ethical or religious.

FDA OKs First Embryonic Stem Cell Research Trial on Humans, Despite Concerns

by Steven Ertelt
LifeNews.com Editor
July 30
, 2010

// Washington, DC (LifeNews.com) — The Obama administration has approved the bid by cloning company Geron to undertake the first trial involving the use of embryonic stem cells in humans. They have never been used before in people because the cells cause tumors and have been plagued by immune system rejection issues when tried in animals.

Scientists and pro-life advocates say human embryonic stem cells are not ready for trial because problems associated with the cells in animals haven’t been solved.

The Food and Drug Administration had initially placed the trial on hold but Geron indicated today that the agency is now allowing it to proceed with an early stage trial on a stem cell therapy for acute spinal cord injury.

The FDA placed a hold on the trial last August, when evidence showed Geron’s GRNOPC1 encountered safety issues when used in animal studies. Geron’s own data showed higher frequency of small cysts within the injury site in the spinal cord of animals injected with the embryonic cells.

“We are pleased with the FDA’s decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed,” said Thomas B. Okarma, Geron’s president, in a public statement today. The company’s stock rose in value following the announcement.

Previously, Dr. John A. Kessler, chairman of neurology and director of the stem cell institute at Northwestern University, said the first application from Geron for the embryonic stem cell trial was flawed.

“We really want the best trial to be done for this first trial, and this might not be it,’’ he said at the time.

Responding to the news today, Dr. David Prentice, a former biology professor at Indiana State University who is now a fellow at the Family Research Council, tells LifeNews.com those concerns should still exist.

“It’s unfortunate that the FDA has released Geron from the safety hold on their embryonic stem cell trial,” he said. “Even many pro-embryonic stem cell scientists have expressed reservations about Geron’s trial, that it is not proven even in rats. The concern for many of us is that Geron is endangering patient’s health and very lives, to make a political point and increase their stock price.”

Prentice also said the trial’s approval makes it so the use of adult stem cells, which are safely helping patients battling more than 100 diseases and conditions already, continue to be ignored.

“In the meantime, adult stem cells have already shown published scientific evidence for safety and successful repair of spinal cord injury in patients. Only adult stem cells offer both an ethical and successful path to healing,” he said.

Prentice also explained that the trial isn’t precisely the first one involving embryonic stem cells — making it so media outlets need to fully explain what Geron is doing.

“They inject cells derived from embryonic stem cells; in this case a cell type called an oligodendrocyte, which is a cell that forms a sheath, like insulation, around nerve fibers,” he said. “So they don’t inject growing embryonic stem cells, but the cells are indeed directly derived from embryonic stem cells, and actually are not completely differentiated, but only part-way (“precursors”).”

“The theory is that once inside the body, the cells will finish specializing to the final cell type, and form an insulative covering over exposed nerves in the spinal cord,” he told LifeNews.com.

Last August, Evan Snyder, a neuroscientist who heads up the stem cell research center at the Burnham Institute for Medical Research in San Diego, warned the research may not be ready for humans.

“There’s a lot of debate among spinal cord researchers that the pre-clinical data itself doesn’t justify the clinical trial,” Snyder, who is working on using neural stem cells himself, says.

Snyder says the mice Geron used to conduct pre-human trial research had more excessive injuries [than] scientists would normally prefer to see prior to trying the procedure on human patients.

He suggests that Geron should have done experiments involving larger animals before seeking FDA permission to use the controversial embryonic stem cells in humans.

Those concerns existed as early as 2005 and may not have been addressed.

Snyder said then that Geron should do more animal testing first to make sure the tests would be on the same injuries humans have.

“I’m not convinced they have done that yet,” Snyder said.

Jerry Silver, a neuroscience professor and stem-cell researcher at Case Western Reserve University in Cleveland, told Knight Ridder back in November 2005 that Geron was moving too fast and needed to do more tests on animals before seeking human patients.

“Frankly, I cannot conceive of a human trial with the use of human embryonic stem cells following immediately from experiments in rodents only,” he said then. “Many treatments that work in rodents to alleviate disease fail miserably in humans.”

Geron came under criticism earlier this year when news surfaced that the application Geron Corporation submitted to the FDA to become the first to engage in human trials of embryonic stem cells was timed with a trigger to make it so it would be considered during the Obama administration. The cloning company worried it would not be approved during the administration of President George W. Bush.

Just days after Obama took office, the FDA suddenly decided to approve Geron’s application for the controversial study.


“There’s stupidity and then there’s just “dumbassedness”. The Obama Administration and FDA okays using embryonic stem cells in humans when every scientist in the field knows they cause tumors and other deadly side effects.” -Boonie



In ALL ARTICLES on July 29, 2010 at 9:24 pm
(PRE) Addendum (there is also a post addendum!):

In the past, I have seen stories pulled from the net that were “too positive” on adult stem cells…I have seen stories re-written 2 and 3 times with no mention of retraction or revision and the re-writing all went in the direction of “more negative on adult stem cells, more promoting of embryonic.”  Perhaps I jumped the gun on this one.  I apologize. I only want to convey accurate info.

I know I am guilty of being jaded by a media (most of the US sources) that bought into the exaggerated promise and potential of embryonic stem cells and the over looked and undervalued status of adult stem cells.  I hope the tides are changing.  The world is backing adult, the Vatican is backing adult, the US Army/Veterans admin is backing adult…only the USA biotech, pharma, government and media has resisted backing adult.

Perhaps that time is coming to an end and the incredible power of adult stem cell treatments can one day be seen in this land originally  built on freedom.  We can only hope.

This story is now up and available.


Adult Stem Cell Research Far Ahead Of Embryonic



“A few months ago, Dr. Thomas Einhorn was treating a patient with a broken ankle that wouldn’t heal, even with multiple surgeries. So he sought help from the man’s own body. Einhorn drew bone marrow from the man’s pelvic bone with a needle, condensed it to about four teaspoons of rich red liquid, and injected that into his ankle. Four months later the ankle was healed…”

[Read the full article here]


Page Not Found


It appears you have come across a page we do not have. This page may have been removed, changed or is temporarily unavailable but don’t go away.

Here are some helpful options to help you find what you’re looking for.


POST ADDENDUM – And now as a follow up, Bradley Fikes of the North County Times shared his personal opinion with me and was gracious enough to allow me to print it (this is his opinion and does not necessarily reflect that of the paper he works for)…

Hello David,

BF here, a reporter in San Diego with the XXX newspaper. Here’s my educated guess as to what happened with the story, “Adult Stem Cell Research Far Ahead Of Embryonic,” which you are free to publish.

The story, from Associated Press writer Malcolm Ritter, was supposed to run on Aug. 2, and was sent to AP subscribers such as us on that basis. A number of sites jumped the gun. I am guessing those sites yanked the story after AP complained.

AP embargoes are often broken, either intentionally or because the editors just forgot to check for an embargo. There’s a temptation to assume that just because something appears in the AP feed, it can be used immediately.

I’m localizing this story for my own paper, because San Diego does a lot with stem cells, both adult and embryonic. On a hunch, I Googled the first few words of the lead, and saw the story appearing in a plethora of places.

Like you, I think Ritter’s story is unusually good. It’s especially good for AP, which often does a lot of sub-standard or biased reporting. AP’s reporters are mainly responsible for that, but also its editors, who don’t do enough quality control.



In ALL ARTICLES on July 29, 2010 at 12:11 pm

This video shows the Health Minister of Scotland discussing current stem clinical trials in Scotland for stroke and for eye repair.  It’s significant that they are in the stem cell game.  One more country recognizing the power of stem cells.

p.s.  It’s a short video and armed with my explanation above, you probably know everything you need to know without even watching it – http://video.forbes.com/fvn/tech/scotland-stem-cell-edge


And now for your viewing pleasure…a pic of Cuillin Mountains in Scotland


Other STROKE articles:

  1. https://repairstemcell.wordpress.com/2010/09/21/autologous-neural-stem-cells-benefit-parkinson%e2%80%99s-patients-adultstemcell-com/
  2. https://repairstemcell.wordpress.com/2010/09/20/stem-cell-treatment-for-stroke-and-traumatic-brain-injury-wholewellness-net/
  3. http://www.scientificamerican.com/article.cfm?id=can-stem-cells-block-stroke-damage
  4. http://www.sciencedaily.com/releases/2011/08/110831160216.htm

LUPUS! Stem Cell Transplant Benefits Severe Lupus

In ALL ARTICLES on July 29, 2010 at 11:43 am

I can’t believe it! I was talking with not one, not 2, but 3 separate people yesterday about the treatment of Lupus and Severe Lupus.  I relayed some general information and this article from June 7th – https://repairstemcell.wordpress.com/2010/06/07/lupus-study-shows-promising-results-using-umbilical-cord-mesenchymal-stem-cells-scimitar-equity-blog/

My final point to each was: check back with me often, things change all the time…

So as I was swilling my coffee this morning and rubbing my eyes; what article do I see at the top of my reading list?

Stem Cell Transplant Benefits Severe Lupus!!

Wow, I can’t believe it!  SO…how much benefit was there?A little, a lot?

SLE disease activity index – 1 year after treatment

  • 12 patients fell to 3.2 from a baseline score of 12.1 and 4 of them showed “remarkable improvement” with scores of zero!!
  • All patients experienced a reduction in 24-hour proteinuria, which decreased significantly by one week from 2,538 mg to 1,430 mg (P<0.01).
  • 8 of 11 patients no longer had fatigue, weight loss, or low-grade fever, three months after transplantation.
  • 4 of 8 patients with cutaneous manifestations had their severe lesions healed completely.
  • 4 of 8 patients with cutaneous manifestations had their severe lesions healed partially.
  • Arthritis improved in four of six patients who had musculoskeletal involvement, serositis resolved in two, neurologic manifestations cleared in one, and refractory hypertension became controllable in five.
  • Antibody levels also fell, with serum titers of anti-double stranded DNA antibodies reaching a statistically significant difference from baseline at one and three months (P<0.05).
  • Two patients relapsed, one at six months and the other at 24 months.
  • No serious adverse events were seen during followup.

I’m so excited to share this information with my friends.  Enjoy everyone and when you finish reading below, you can click here to read the technical data of the study

CONTACT ME directly for information on where to get LUPUS and SEVERE LUPUS treated TODAY – dsgrano@gmail.com

Stem Cell Transplant Benefits Severe Lupus

By Nancy Walsh, Staff Writer, MedPage Today
Published: July 29, 2010
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.

Allogeneic mesenchymal stem cell transplantation resulted in improvements in disease activity, serologic markers, and renal function in patients with refractory systemic lupus erythematosus (SLE), a pilot study conducted in China found.

Twelve months after stem cell transplantation, scores on the SLE disease activity index among 12 patients fell to 3.2 from a baseline score of 12.1 (P<0.05), according to Jun Liang, MD, of Nanjing University, and colleagues.

Four of those patients showed “remarkable improvement” at one year, with scores of zero, the researchers reported online in the Annals of the Rheumatic Diseases.

Action Points <!— –>

  • Explain to interested patients that a small study found improvements in severe refractory lupus with stem cell transplantation.
  • But caution them that larger, randomized studies will be needed to confirm these findings and to provide longer follow-up.

Some patients with refractory SLE remain symptomatic and at risk for progressive organ damage, including lupus nephritis, even with highly potent immunosuppressive regimens.

Hematopoietic stem cell transplantation has been tried in a few cases and led to some improvement, but was associated with mucositis, infections, and pulmonary injury.

Mesenchymal stem cells are less immunogenic then hematopoietic stem cells, because they lack the expression of costimulatory molecules and can escape alloantigen recognition.

Recent studies have suggested that mesenchymal stem cells from patients with SLE are defective in several ways, including their cytokine secretion, phenotype, growth, and immunomodulatory activities.

Liang and colleagues therefore hypothesized that SLE is a mesenchymal stem cell-mediated disease, and suggested that allogenic, rather than autologous, bone marrow mesenchymal stem cell transplantation might be an effective treatment.

So between March 2007 and November 2008 they enrolled 15 patients (14 women) with refractory disease along with healthy family member donors. The patients’ average age was 28.3 years, and average disease duration was 91.1 months.

Maintenance treatment one month after the transplantation included prednisone, 5 to 10 mg/day, and cyclophosphamide, 0.4 to 0.6 g every two to three months.

No other immunosuppressive medications were permitted unless a patient relapsed.

Mean follow-up was 17.2 months, and 13 of the patients had been followed for at least one year.

All patients experienced a reduction in 24-hour proteinuria, which decreased significantly by one week from 2,538 mg to 1,430 mg (P<0.01).

Among 11 patients who had longstanding fatigue, weight loss, or low-grade fever, eight no longer had these symptoms three months after transplantation.

Additionally, in eight patients who had cutaneous manifestations, severe lesions healed completely in four and at least partially in the other four.

Arthritis improved in four of six patients who had musculoskeletal involvement, serositis resolved in two, neurologic manifestations cleared in one, and refractory hypertension became controllable in five.

Antibody levels also fell, with serum titers of anti-double stranded DNA antibodies reaching a statistically significant difference from baseline at one and three months (P<0.05).

Two patients relapsed, one at six months and the other at 24 months.

No serious adverse events were seen during followup.

Possible mechanisms by which allogeneic mesenchymal stem cell transplantation might improve lupus include altering the cytokine profile toward a Th1 phenotype and expansion of regulatory T cells, which suppress the activity of autoreactive T cells, according to the researchers.

In this study, the effect of transplantation on regulatory T cells was assessed by flow cytometric analysis of the Foxp3+ CD4 T-cell subset, determining that the percentage of these cells increased to 4.58 from 2.56 (P<0.05) at baseline.

Another possible mechanism involves the ability of mesenchymal stem cells to differentiate into endothelial cells. Patients with lupus exhibit excessive endothelial cell apoptosis by serum IgG, and alterations in endothelial cells are thought to contribute to nephron damage.

“We hypothesize that, to some extent, differentiation of [mesenchymal stem cells] to endothelial cells reconstructs the structure of the nephron and improves renal function,” Liang and colleagues wrote.

However, they added, there are as yet no data to confirm or refute this hypothesis.

They noted that their follow-up was short, and that randomized trials will be needed to test this approach against more conventional therapies and to clarify clinical response criteria, post-transplant immunotherapy, and treatment of relapses.

The study was supported by the National Natural Science Foundation of China, Jiangsu Province Talent Foundation, and Jiangsu Province Natural Science Foundation.

No other disclosures were provided.

Medical Marijuana For Staph; Other Ailments (GFON)

In ALL ARTICLES, SCIENCE & STEM CELLS on July 28, 2010 at 11:38 pm

Also from April, 2009…

Medical Marijuana reduces the spread of drug-resistant bacteria, including methicillin-resistant Staphyloccus aureus (MRSA).  Just one more use for medical marijuana…

marijuana hemp uses weed grass

From BioHealth Investor – Biotech and Medical Business Blog – April 23, 2009

It is hard to imagine that there are now two medical-related marijuana companies that are public stocks. But that is the new world for you. Cannabis Science, Inc. (OTCBB: GFON) has a report on the current state of research into the use of natural plant cannabinoids to reduce the spread of drug-resistant bacteria, including methicillin-resistant Staphyloccus aureus (MRSA), and the prospects for development of topical whole-cannabis treatments.

The company noted a Journal of the American Medical Association and a Center for Disease Control in 2007 report, showing that MRSA is responsible for more than 18,500 hospital-stay related deaths each year, and increased direct healthcare costs of as much as $9.7 billion.

Dr. Melamede, chief scientist and director at Cannabis Science, Inc., noted that research into use of whole cannabis extracts and multi-cannabinoid compounds has provided the scientific rationale for medical marijuana’s efficacy in treating some of the most troubling diseases mankind now faces. What is interesting is that the reference was made to infectious diseases such as the flu and HIV, autoimmune diseases such as ALS, multiple sclerosis, arthritis, diabetes, neurological conditions such as Alzheimer’s, stroke and brain injury, and numerous forms of cancer.

via Medical Marijuana For Staph & Other Ailments (GFON) : BioHealth Investor – Biotech and Medical Business Blog.


In VICTORIES & SUCCESS STORIES on July 27, 2010 at 6:43 pm

Robot Assisted Stem Cell Therapy a First in Thailand


Bangkok, Thailand (PRWEB) November 9, 2005 – In a historic operation, surgeons at Bangkok Heart Hospital performed Thailand’s first robot-assisted cardiac stem cell implantation on October 27, 2005. Utilizing Intuitive Surgical’s da Vinci Surgical System and VesCell™ adult stem cell therapy for heart disease from TheraVitae Ltd., surgeons treated a no-option, ischemic cardiomyopathy patient from Fayetteville, Arkansas, USA.

Dr. Kitipan V. Arom and Sujit Banyatpiyaphod utilized the da Vinci system to make the initial pericardial incision. They then implanted the stem cells directly into the patient’s heart using the minimally invasive stem cell injection technique pioneered by Dr. Amit Patel, Director of Cardiac Stem Cell Therapies at The McGowan Institute for Regenerative Medicine, University of Pittsburgh Medical Center (UPMC) and Dr. Arom, who is the Chief Cardiac Surgeon at Bangkok Heart Hospital.



Robotically assisted surgery requires only three small holes be made between the ribs. Through these holes, two robotic arms and a videoscope gain access to the heart, making surgery possible without opening the chest.

“We are proud to be associated with hospitals like Bangkok Heart Hospital,” said TheraVitae’s Founder, Don Margolis. “They are merging the latest medical technology and surgical techniques to improve the lives of seriously ill heart patients who cannot be treated by conventional means and would otherwise have no hope,” he added.


About VesCell™
VesCell™ uses a patient’s own adult stem cells to treat Heart Disease and is a viable alternative for patients who either cannot undergo or choose not to undergo the standard treatment such as Coronary Artery Bypass Grafting (CABG).

VesCell™ uses adult stem cells harvested from approximately ½ pint of the patients own blood to treat several heart conditions. Once harvested, the cells are differentiated and expanded in vitro at TheraVitae’s Labs in Israel. They are ready for implantation in about one week.

VesCell Web Site – http://www.vescell.com
Stem Cell Therapy Blog – http://www.stem-cell-therapy.vescell.com

About TheraVitae
TheraVitae is a private, multinational company focused on using stem cells from the patient’s own blood in order to treat a variety of disorders, especially cardiovascular diseases. The company has developed a proprietary stem cell technology called VesCell™ that is currently being used by hospitals in Thailand to treat patients with heart disease. TheraVitae is based in Bangkok, Thailand, Kiryat Weizmann, Israel, and Hong Kong.

TheraVitae Corporate Web Site – http://www.theravitae.com

About Bangkok Heart Hospital
Bangkok Heart Hospital (BHH) – the first private heart hospital in Thailand – is a leading institution in the treatment of cardiac-related disease using adult stem cells. The hospital is currently using TheraVitae’s VesCell™ adult stem cell product to treat cardiomyopathy in no-option heart patients. Additionally, BHH has initiated a clinical trial using VesCell™ in conjunction with Coronary Artery Bypass Surgery (CABG) to treat congestive heart failure.

BHH is comprised of experienced adult & pediatric cardiologists, cardiac surgeons, cardiac anesthesiologists, cardiac rehabilitation physicians and radiologists who have trained and worked overseas in countries such as the United States, Australia and Japan. Their well-trained and experienced nurses, technicians and paramedical personnel provide 24-hour care for all cardiac conditions.

Bangkok Heart Hospital Web Site – http://www.bangkokheart.com

Author Information:
Jay D. Lenner Jr.
TheraVitae Ltd.

via Robot Assisted Stem Cell Therapy a First in Thailand.

“Stem Cell Awareness Seminar”

In STEM CELLS IN THE NEWS on July 27, 2010 at 5:36 pm

“Stem Cell Awareness Seminar”

  • Tampa, Florida
  • August 28,2010 1:00pm – 5:00pm
  • Free Admission – open to the public

Learn the Truth regarding the differences between embryonic and adult stem cell treatments. Doctors, patients and others will share their knowledge and experiences with you and answer any questions you may have on stem cells.

Regenerative stem cell therapies for diseases, disorders and injuries will be discussed: ALS, Alzheimer’s disease, Ataxia, Autism, Cerebral Palsy, Diabetes, Heart disease, Lupus, Multiple Sclerosis, Muscular Dystrophy, ONH & optic disorders, Parkinson’s disease, Spinal Cord Injury and Stroke patients have shown significant improvements after treatment.

Several doctors will speak about the progress they have noted in their patients. They will share information with you both pre and post stem cell therapies. You will also hear from several stem cell patients who will share their personal experiences and views of this regenerative therapy. You can also read documented case studies of adult stem cell patients.

David Granovsky, author of “The Stem Cell Blog” and the 1st children’s book on stem cells  “Super Stemmys Doris and the Super Cells” will begin the discussions.

We look forward to meeting you!


Marriott Tampa Airport Hotel
Tampa International Airport
4200 George J. Bean Pkwy.
Tampa, Florida 33607

Hotel Reservations 800-564-3440, ask for Stem Cell awareness room block or Http://www.marriott.com/hotels/travel/tpaap? group Code= STCSTCA


Please RSVP by filling out the following survey:



Carol Petersen
Stem Cell Advocate
Ph: 1-941-235-0088


Osiris – FLASHBACK to Sept, 2009

In BUSINESS OF STEM CELLS on July 26, 2010 at 6:07 pm

I think this paragraph from Sept 2009 is as true today as it was almost a year ago -dg

Certainly major pharma companies are tracking the news flow from Osiris closely. Keenly aware that they got into the biologics game too late, but nonetheless wary of the incredibly complicated biology involved, Big Pharma is in a state of cognitive dissonance when it comes to stem cells. “They’d like to see a true product,” Giebel says, noting that the preference is for allogeneic therapies, “because one size fits all.” The problem with creating an allogeneic therapy, which arguably could be treated as a product in the traditional pharma sense, is that the stem cells are derived from someone other than the ultimate recipient, bringing into play the challenge of immune response. (Mesenchymal stem cells are unique in that they are not “seen” by the immune system and in fact have the effect of down-regulating T-cells, making them potentially effective in autoimmune indications, like GvHD.)

Osiris Hiccup In COPD Barely Registers In Stem Cell Sector

…Lazard analyst Joel Sendek, for example, advised investors to wash their hands of the company, based on the COPD slip and earlier troubles with a clinical trial in Crohn’s disease that resulted in a high placebo response. But for the most part, investors and analysts shrugged off the data, choosing to view it as a learning experience in a secondary indication, while keeping their eyes focused on the pending GvHD results.

It would have been nice to see Prochymal succeed in COPD because that’s a very large market, “but is it a major setback? I don’t think so,” says Lutz Giebel, PhD, a managing partner at SV Life Sciences. Giebel co-founded the embryonic stem cell company CyThera Inc. in 1999; the biotech merged with another SC company, BresaGen Inc., in 2004 to form Novocell Inc.

Certainly major pharma companies are tracking the news flow from Osiris closely. Keenly aware that they got into the biologics game too late, but nonetheless wary of the incredibly complicated biology involved, Big Pharma is in a state of cognitive dissonance when it comes to stem cells. “They’d like to see a true product,” Giebel says, noting that the preference is for allogeneic therapies, “because one size fits all.” The problem with creating an allogeneic therapy, which arguably could be treated as a product in the traditional pharma sense, is that the stem cells are derived from someone other than the ultimate recipient, bringing into play the challenge of immune response. (Mesenchymal stem cells are unique in that they are not “seen” by the immune system and in fact have the effect of down-regulating T-cells, making them potentially effective in autoimmune indications, like GvHD.)

Meanwhile, autologous therapies, in which the patient’s own cells are collected, treated, and put back in, are more transplant than therapy, and not an appealing acquisition for pharma in Giebel’s opinion. But given the nascent state of the field and as yet no clear clinical success stories, there are many others with divergent views.

via BioPharma Today: Osiris Hiccup In COPD Barely Registers In Maturing Stem Cell Sector.

Eyes on the Road; Hands on the Wheel: OSIR, EFII, HEV : Small Cap Stock Analysis : Small Cap Stocks and Penny Stocks For Big Returns – SmallCap Network

In BUSINESS OF STEM CELLS on July 26, 2010 at 5:58 pm

What’s it all about?

Osiris is utilizing smart marketing technique and business strategy by first dipping their foot into the shallow end of the stem cell therapy pool.

They want to treat Heart, Diabetes, GI and joints with their stem cell product “Prochymal” so they are wisely starting by treating graft versue host disease (GVHD) in bone marrow transplant (BMT) recipients.

[Standard treatment for GVHD is corticosteroids (used to suppress the T-cell mediated immune onslaught on the host tissues).] 

This really won’t ruffle too many pharma feathers and BMT’s and GVHD have a ~40 year history.  Then they piggy back diabetes, heart, crohn’s, etc on top of the approval for the GVHD treatment .  Wise move.  I hope it works! – dg]



Osiris Therapeutics (OSIR) Climbs on Regulatory Milestone

By Dennis Askew – Published: July 26, 2010 9:06:08 AM PDT

OSIR: Health Canada Grants Priority Review for Stem Cell Therapy

First up this morning we have Osiris Therapeutics Inc., (OSIR) http://www.osiristx.com/ currently trading in the $7.79 range on a 3-Month average daily trading volume of 108,303 shares. OSIR has a 52-week high of $15.20 set on 08-27-09 with current trailing twelve month revenues of $43+ million and a positive, corresponding diluted EPS of +$0.07. I like those earnings.

Last week the Biologics and Genetic Therapies Directorate of Health Canada completed its initial evaluation and accepted for full review OSIR’s New Drug Submission of Prochymal, an adult stem cell therapy for the treatment of graft vs. host disease.

[Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as “foreign” and mount an immunologic attack. It can also take place in a blood transfusion under certain circumstances. – wiki

Side note: GVHD is virtually eliminated when using autologous (from the patient’s own body) stem cells for treatments. -dg]

Based on a separate review of summary clinical data, Health Canada notified OSIR that the application has been granted Priority Review, shortening the examination period from 300 to 180 days. If successful, Prochymal would become the world’s first approved stem cell therapy.

[“the world’s first approved stem cell therapy” Not quite right:

  1. There are already dozens if not hundreds of approved THERAPIES in the world going back over half a decade….
  2. What is Prochymal, then? Prochymal is an allogenic (from a donor) , ex vivo (outside the organism) cultured  batch of mesenchymal (bone marrow) stem cells implanted into the patient who has received a bone marrow transplant in the interest of suppressing his immune response so the new/foreign bone marrow can take seed.
  3. So…Prochymal may become the first stem cells derived from (allogenic) outside sources and cultured (ex vivo) in a dish to be approved for use in a human patients with GVHD…IN THE USA.
  4. In related news; in September of 2009, Stemedica (a different company) was granted a license to manufacture stem cells for therapiesStemedica Licensed to Manufacture Clinical Grade Stem Cells

– dg]

Prochymal, which is in Phase III clinical trials for the treatment of acute and steroid refractory graft versus host disease and Crohn’s disease, as well as for the repair of gastrointestinal injury resulting from radiation exposure. OSIR is also developing its Prochymal drug candidate for the repair of heart tissue following a heart attack, and for the protection of pancreatic islet cells in patients with type 1 diabetes.

OSIR is also developing Chondrogen, a biologic drug candidate for the treatment of osteoarthritis and the reduction of pain in the knee. At nearly 50% off its high, returning ttm earnings, and making product-to-market strides, OSIR is a long-term (1 Yr) ‘Buy’ consideration for me.

via Eyes on the Road; Hands on the Wheel: OSIR, EFII, HEV : Small Cap Stock Analysis : Small Cap Stocks and Penny Stocks For Big Returns – SmallCap Network.

Oman: Stem cell bank ‘to open soon’

In STEM CELLS IN THE NEWS on July 26, 2010 at 4:00 am

The World Health Organization’s “health system ranking” puts the Arab country of Oman at 8th in the world, way ahead of the USA at 37th.  It’s a shame…

but I guess it makes sense that they are moving forward on autologous/adult stem cell research and stem cell banking faster than the US is. -dg

Oman: Stem cell bank ‘to open soon’

26 July 2010

MUSCAT: Stem cell therapy has the potential to radically change the treatment of human disease. Stem cells are the natural repair kit of the human body.

Considering the absorption of such a revolutionary method by advanced countries the Sultanate of Oman is almost on the verge of operating the Stem Cell Bank and establishing a stem cell transplantation unit. According to Dr Muhanna Al Muslahi, senior consultant haematologist and head of directorate of pathology and laboratory medicine, the Royal Hospital, ‘The stem cell bank has been established – tested and connected. Reagents and certain consumables required for harvesting and storing stem cells have been ordered and are on the way. Once they are received stem cell bank will start functioning any time now.’

He said, ‘To begin with, sick patients will be given priority and later when we expand we will store stem cells from all those who want to store them for future treatment. For transplantation unit to be established, special treatment rooms have been made available within the extension of National Oncology Centre. In Oman, the inherited blood disorder disease is not uncommon and so the facility will be a boon to the people of Oman. But the transplantation unit is the second step as first we need the stem cell bank to function which can happen any time now.’

Two staff have been trained at the King Hussein Medical Centre, Jordan – one in stem cell collection and the other in processing and storage. Two other staff have been trained at the Royal Free Hospital in London for six weeks recently. They include Mohammed Ali Al Rawahi, Zahra Al Mahrazi, Fakhra Al Farsi and Suhila.

The department has two doctors under training in Canada and Saudi Arabia and expect them back after two years.

Says Dr Muhanna, ‘Autologous stem cell collection (The autologous stem cell transplant involves relocation of cells from the patient’s own blood) and transplantation unit will also be initiated by the year-end or beginning of 2011 once the expansion of the National Oncology Centre has been completed.’

// He adds, ‘Cold blood storage is also feasible, but it will not be offered at the moment.

It can be considered in the future once the current transplant centres in the country are expanded and the need for cord blood transplants are established justifying the cost of storage and ethical issues behind it.

“In the long term allogenic bone marrow will also be needed to be considered after assessing the projected workload, costs and budgeting requirements and availability of other related services.”By Aftab H Kola

© Times of Oman 2010

via Oman: Stem cell bank ‘to open soon’.

%d bloggers like this: