Stem cell pioneer sets sights on Japan – Japan Times features Neil Riordan, PhD of Medistem Panama

Japan Times Article Medistem

“We enjoy the advantage of having a large amount of clinical data on 2,000 patients. So we analyzed who received which cells and which cells worked best in different conditions. This allowed us to create our selection process through molecular profiling,” explained Medistem (Panama) Founder and CEO Dr. Neil Riordan.

Operating what is arguably the country’s most advanced laboratory, an 8,000-sq-ft facility in the City of Knowledge science and technology cluster, Medistem has raised its profile in recent years as it develops stem cell-based products for clinical trials for treatment of autism, asthma, multiple sclerosis, osteoarthritis, rheumatoid arthritis and spinal cord injuries.

Utilizing its patented technologies, Medistem harvests human adult stem cells from umbilical cords, tissues and blood as well as from bone marrow and adipose tissue. “We have intellectual property on a methodology for basically defining which are good cells, which are mediocre and which are the useless ones. The U.S. Food and Drug Administration has approved our cells for compassionate use in the United States. This is a big step,” Riordan said.

Compassionate use, also known as expanded access, refers to the use of investigational new drugs outside of a clinical trial by patients with serious, life-threatening conditions. After finishing its first prospective clinical trial, and with six others in the pipeline, the company is considering the favorable regulatory conditions for cell therapy in Japan, now a promising market for its products.

“Japan has a law on the books that allows a company of our size to commercialize such products. That makes it our number one priority. We are gearing up to present our data to regulators, as well holding talks with potential partners over there,” Riordan added.

New article concludes US FDA restrictions hampering stem cell therapy progress

FDA-NotApprovedStampAn article published this month in Thieme Journal of Knee Surgery entitled, “The Use of Biologic Agents in Athletes with Knee Injuries” concluded that “Biologic agents… are becoming the mainstay of nonoperative therapy in the high-demand athletic population.” but “…Unfortunately, strict regulations by the FDA continue to restrict their application in clinical practice.”

The good news is they also believe, “As the volume and quality of evidence continue to grow, biologic agents are poised to become an integral component of comprehensive patient care throughout all orthopedic specialties.”

The article is authored by Michaela Kopka and James P. Bradley from the Department of Orthopaedic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.

Abstract

Biologic agents are gaining popularity in the management of bony and soft tissue conditions about the knee. They are becoming the mainstay of nonoperative therapy in the high-demand athletic population.

The most well-studied agents include platelet-rich plasma (PRP) and stem cells—both of which have shown promise in the treatment of various conditions. Animal and clinical studies have demonstrated improved outcomes following PRP treatment in early osteoarthritis of the knee, as well as in chronic patellar tendinopathy. Early clinical evidence also lends support for PRP in the augmentation of anterior cruciate ligament (ACL) reconstruction. Research investigating the role of biologic agents in collateral ligament and meniscal injuries is ongoing.

Studies assessing the utility of stem cells have shown encouraging results in the setting of osteoarthritis.

Unfortunately, strict regulations by the FDA continue to restrict their application in clinical practice. A major limitation in the interpretation of current data is the significant variability in the harvesting and preparation of both PRP and stem cells.

As the volume and quality of evidence continue to grow, biologic agents are poised to become an integral component of comprehensive patient care throughout all orthopedic specialties.

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Cutting edge: Surgeon uses stem cell surgery on stem cell researcher Neil Riordan PhD

Wise County Messenger
By Bob Buckel | Published Wednesday, July 31, 2013

A middle-aged man named Neil got his knee “scoped” in a Decatur operating room recently.

That’s not unusual. Wise Regional Health System’s OR is a busy place, and arthroscopic knee surgery is a common procedure.

But this particular knee had an interesting twist.

Wade McKenna MD and Neil Riordan PhD in OR

IN THE OR – Dr. Wade McKenna performs stem cell surgery on stem cell researcher Neil Riordan PhD.

The physician doing the surgery, Dr. Wade McKenna, met his patient when they shared a podium at a medical conference in February. The patient, Neil Riordan, has a Ph.D. in molecular biology and is one of the leading stem cell researchers in the world.

Riordan’s surgery, a fairly routine cleanout, ended with the insertion of a concentrate of his own stem cells back into the knee, to promote healing, foster cartilage regeneration, and reduce inflammation and the possibility of infection.

It’s a procedure Dr. McKenna has done more than 1,500 times, right here in Decatur, for a variety of fractures, cartilage and tendon injuries. Last year he operated on patients from four countries.

“It’s been mostly in the last three years, and really, the bulk of those in the last year,” he said. “It’s not like I have a newspaper ad that says ‘Stem Cell Surgeon.’ It’s just, you do a patient whose doctor calls you, and that doctor has a family member that he calls you about. Almost all these patients know someone I’ve already taken care of.”

He cited a doctor in Oklahoma who flew his wife down for knee surgery, and a radiologist who reviewed before and after MRIs of one of his procedures and saw actual cartilage growth.

“He calls me on the phone and says, “How did you do that? I’ve never seen condromilatia going the other direction. I’ve only seen it get worse.’” McKenna said. “He ends up sending his father-in-law, who’s from Canada, down to have the surgery. And that guy from Canada goes back and tells… so that’s how it’s happened.”

The surgeries are mostly routine – but the addition of bone marrow-derived stem cells afterward is a game-changer.

“Stem cells change the environment for healing in the joint,” Dr. McKenna said. “It’s like finding the light switch in a dark room. It looks like stem cells are the sentinel cells, the messenger cell – the light switch.

“It makes a substantial difference,” he added.

The journey that brought Neil Riordan to an operating table in Decatur started in Florida.

In February, at the International Stem Cell Society Conference in Fort Lauderdale, he spoke about research he’s doing in Panama that involves taking stem cells from a patient’s own fat, drying them, multiplying them and re-injecting them into the patient to promote healing.

McKenna spoke later about the technique he’s using. His method caught the researcher’s interest in part because it’s one of the few stem cell applications that’s legal in the U.S.

After he presented his results – broken clavicles to ankles to shoulders to arthritic knees – Riordan was interested enough to invite McKenna to dinner.

“He said he wanted to talk to me about some of the clinical experience I’ve had,” McKenna said. “He had not, to that point, been exposed to anyone who had that much experience with bone marrow-derived stem cells.”

Since then, they’ve gotten together several times – Riordan lives in Dallas and has a lab in Farmer’s Branch – and have “gone through a lot of research together,” McKenna said.

And somewhere in there, Riordan decided he might be a candidate for McKenna’s procedure.

CLEANING IT UP

“Neil saw all these films I’d taken and thought, ‘I’m ignoring a bunch of loose stuff floating around in my knee.’” McKenna said.

“It was only a couple of weeks ago – we’d been looking at a lot of cell cultures, and spending a lot of time in the lab in Dallas, and he finally just said, ‘Examine me. Put your hand here.’”

It was quickly obvious to the experienced surgeon that his research partner needed some work.

“I thought, ‘What are you doing?’” McKenna said. “He’s got locking, catching, giving way. I tell people all the time, you can ignore pain and swelling, but you can’t ignore mechanical symptoms. If something’s getting caught in your knee, it makes pretty intuitive sense to take that out, and your knee will feel better.”

To that point, Riordan’s focus had been simply on the application of stem cells – not combining it with surgery to clean out the joint and improve its mechanical function. Visiting with the surgeon, it made sense to combine the procedures.

Riordan himself explained it in an interview prior to his surgery.

“I still have stem cells in my bone marrow,” he said. “He’s going to pull some of those out and put them in the knee, the place where they’re needed.”

Riordan said the idea is to help the knee heal like it would have when he was much younger.

“When you’re young, you have a whole bunch of stem cells,” he said. “All we’re doing is just putting more of them in the right place at the right time to help people get over stuff. That’s what it boils down to.”

Riordan’s torn ACL, meniscus damage, adhesions and other knee problems were the result of an injury in 2002 where his knee swelled up, then “kind of” got better, McKenna said.

In surgery, to the constant beeping of the heart monitor and the ree-ree-ree of the pedal-operated instrument shaving off debris and vacuuming it out, the surgeon narrated while he operated.

“Just getting all the junk out of your knee, while it doesn’t give you a new knee, it certainly turns back the hands of time a little bit,” McKenna said. “He was just walking around, doing everything on this without seeking treatment.”

Fluid circulated through the knee and everyone watched the instruments on multiple big-screen television monitors in the OR.

“It didn’t make a lot of sense to start squirting stem cells into his knee until you clean it out a little bit,” McKenna said. “Even with the greatest stem cells in the world, if you just squirt it into that crummy knee with all that loose junk – none of that was going away.

“At least now, you see the difference in the joint. This has a chance of healing.”

After trimming for over an hour, removing frayed cartilage, bone spurs and adhesions, McKenna was ready to inject the bone-marrow aspirate that had been spinning just a few feet away.

THE KEY INGREDIENT

Prior to going into the knee, McKenna harvested bone marrow from Riordan’s left hip-bone and delivered it to a technician who put it into a specially-designed centrifuge.

Using the patient’s own stem cells makes the surgery legal in the U.S. Concentrating the bone marrow with a centrifuge makes it much more effective, based on the results McKenna has observed.

“A lot of doctors, when I say we’re doing bone marrow draws, they say there’s no stem cells in an adult,” he said. “That’s just not true. We’ve done the cell counts. I get over a million cells out of this harvest.”

He said the injection of stem cells accomplishes the same thing as microfracture – cracking the joint surface to bring bone marrow to the surface. It just does it better.

“In my mind, it’s not a big leap of faith to think that if a couple of drops of bone marrow from a worn-out knee help it heal, what would the equivalent of 110 ccs of spun-down, concentrated bone marrow with only the best parts do?

“That’s how we invented this surgery. No one had ever done microfracture surgery with bone marrow spread, and we did that in Decatur about five years ago.”

McKenna said the bone marrow from the ileac crest – the hip-bone – has more stem cells and growth factors than what’s in the knee – or on the market.

“There’s a patch that has about 60,000 donor stem cells and you can use that to help tendons heal,” he said. “But would you rather have 60,000 donor stem cells from someone else, that only have a viability of about 75 to 80 percent, or would you rather have 1 to 2 or 3 million of your own stem cells, with a viability of over 90 percent, that were taken at the time?

“They haven’t been freeze-dried, they haven’t been processed, they’re not from someone else – they’re yours. It’s a no brainer.”

“And the stem cells are delivered in a ‘slurry’ of concentrated growth factor,” he said.

“Now we’re on the right track, because the trophic factors are how you heal anyway. It’s how tendon heals, muscle heals, it’s how the body grows cartilage, grows tissue. It’s what stimulates growth and healing.

“We’re not doing anything abnormal,” he added. “This is the body’s normal physiology and reaction to disease. All we’re doing is adding a little gas to the engine.”

STEM CELL PIONEERS

Riordan, who has written more than 60 articles and chapters in two textbooks, speaks all over the world about stem cell therapy.

His research in Panama focuses on amniotic stem cells, taken from the “afterbirth” – the umbilical cord and amniotic sac – which would normally be disposed of after a baby is born.

“The amniotic membrane is actually what covers the baby in the womb, and that is what we use,” Riordan said. “There are 120-200 million stem cells inside of an amniotic membrane. They help in healing, decrease inflammation, decreasing adhesion formations, which is a real problem in surgery, particularly spine surgery. They promote and stimulate regeneration.”

Riordan’s clinic, Medistem Panama, is in an area just outside of Panama City called the City of Knowledge. Several major universities and research labs have located facilities there because of tax incentives and relaxed regulation.

Both stressed that the research in Panama uses amniotic tissue – not fetal tissue. Most stem-cell researchers reject the use of fetal tissue both for ethical reasons and because they’re simply not needed.

“The big political uproar about stem cell research is misguided,” he said. “Nobody is using fetal tissue. The only tissue that’s used is either the patient’s own tissue, or, better, amniotic tissue. That amniotic membrane is a very rich source of mesenchymal stem cells. That’s where a lot of Neil’s research is now.”

Riordan believes the FDA’s regulation of stem cells is misguided.

Speaking at a conference last July in Arizona, he said the FDA needs to view stem cells as what they are – human tissue – not a drug. He pointed out that hearts, lungs, kidneys, corneas, skin and other organs are transplanted in the U.S. every day, all without FDA approval.

“The drugs that suppress your immune system so you can receive that heart and survive – those are FDA approved, but the transplant isn’t,” he said. “It’s a procedure. It’s exempt.”

“I think ultimately these (stem cells) should be exempt as well, and should fall under the practice of medicine. That’s my opinion.”

For now, McKenna’s groundbreaking use of stem cells continues to pile up impressive results, providing clinical backup for the research done by people like Riordan.

And every day, it becomes more obvious that the use of stem cells holds the potential for healing across the entire spectrum of human suffering.

“Now, it’s not only about keeping your cartilage from wearing out, it’s about, ‘Can we grow cartilage and help you heal the joint?’” McKenna said. “The answer to that right now is yes-ish. In the not-too-distant future, the answer is yes.”

“It’s an exciting field,” Riordan said.

Mesenchymal Stem Cells Stop Arthritis in its Tracks – Duke University

Researchers at Duke University announced a promising new stem cell therapy aimed at osteoarthritis prevention after a joint injury.

The probability of developing arthritis after injury (post-traumatic arthritis – PTA) greatly increases after injury. Currently, the US FDA has not approved any drugs that slow or eliminate the progression of PTA.

However, at Duke researchers are beginning to confirm mesenchmal stem cell (MSCs) therapy in arthritis treatment. The treatment is similar to that which professional athletes and others have been seeking abroad in places like Panama and Germany for the past few years.

Ref: Pro/Am Dancer is “Dancing with the Stars” Again After Stem Cell Therapy in Panama

In the study, mice sustaining fractures that commonly lead to arthritis were treated with MSCs. “The stem cells were able to prevent post-traumatic arthritis,” said Farshid Guilak, Ph.D., director of orthopaedic research at Duke and senior author of the study.

The study was published on August 10 in Cell Transplantation.

Lead author Brian Diekman, Ph.D said the scientists observed markers of inflammation and noted that the stem cells affected the joint’s inflammatory environment following injury.

“The stem cells changed the levels of certain immune factors, called cytokines, and altered the bone healing response,” stated Diekman.

The Duke team used mesenchymal stem cells isolated from bone marrow. Bone marrow stem cells are very rare; making isolation difficult and requiring that the isolated cells be cultured in the lab under low-oxygen conditions.

“We found that by placing the stem cells into low-oxygen conditions, they would grow more rapidly in culture so that we could deliver enough of them to make a difference therapeutically,” Diekman said.

A richer source of mesenchymal cells is adipose (fat) tissue. Therapeutic doses of MSCs are routinely harvested from fat tissue and do not require culturing in the lab. However, it does takes 5 five days to thoroughly test the adipose cell samples for aerobic bacteria, anaerobic bacteria and endotoxins.

Ref: Stem Cell Therapy for Osteoarthritis

2012-08-10T17:45:51+00:00 August 10th, 2012|Adult Stem Cells, News, Osteoarthritis, Stem Cell Research|

Why does fat (adipose) stem cell therapy take more than one week?

Intravenously administered adipose-derived stem cells will tend to migrate back to the fresh wound site if it is not given an adequate time to heal. Therefore, it is essential to allow about one week after the mini-liposuction before administering any stem cells intravenously. Otherwise, there is a likelihood that the treatment will not be as effective. Additionally, it takes 5 five days to thoroughly test the adipose cell samples for aerobic and anaerobic bacteria as well as endotoxins.

In order to ensure that no patient receives an infected sample, at least 5 days must transpire before the cells can be confirmed safe and injected back into the patient.

Lastly, this 5-day waiting period enables our scientists to culture a small sample of each patient’s stem cells in the lab to observe how they are likely to proliferate once they are inside the body. If a patient’s cells show low viability, Stem Cell Institute doctors will supplement the treatment with additional cord-derived cells to compensate. The same can be done in cases of low cell yield.

Adult Stem Cells Continue Going to the Dogs

Zack was suffering from a number of degenerative osteoarthritis conditions, despite the fact that he is only 14 years old. Of course, for a dog, 14 is not young. Fortunately for Zack, however, his owner decided to allow him to try stem cell therapy.

According to Deanna Winter, Zack’s owner who is also a doctor for people, "His main problem is arthritis. Trouble walking, trouble sitting and going upstairs." Furthermore, she adds, "His belly was almost touching the ground because he couldn’t hold his hips up. His quality of life was going down. He couldn’t make it around the block anymore."

Dr. Benjamin Ealing at Broad Ripple Animal Clinic in Indianapolis, not far from Zack’s home, has already used autologous adult stem cell treatment on 13 other dogs, successfully in each case. Dr. Ealing surgically removes abdominal fat from the dog, "which about fits in the palm of your hand and fills up two tubes", he describes. The adipose tissue is then shipped to the Vet-Stem laboratories in California where the stem cells are isolated, purified, expanded and returned to Dr. Ealing within 48 hours, already in syringes and ready to be injected into the site of the afflicted joints – which in Zack’s case were a hip and a shoulder. Although results are usually noticeable immediately, the greatest results take about 2 weeks to manifest. Now, two months later, Zack "can walk and he can sit and he can jump and he can go up stairs", as Deanna describes.

As Dr. Ealing adds, "The stem cells are the body’s own natural healing cells. Those cells then recruit the body’s own natural healing cells to come to that area, reduce inflammation, potentially to regenerate damaged tissue."

By now, Zack’s story is becoming an increasingly familiar one. As previously reported a number of times on this website, the company Vet-Stem continues to see consistently high success rates in both canine and equine clinical applications, with an 80% efficacy rate and a 100% safety rate in the animals that are treated with Vet-Stem’s autologous adult stem cell procedure. In other words, 80% of the animals treated are found to experience improvement in their condition with a reduction and often a full elimination of the need for medication, while adverse side effects have not been reported in any of the treated animals.

Since Vet-Stem first began marketing their services, they have now treated more than 2,000 dogs and more than 3,000 horses with autologous adult stem cells, extracted from each animal’s own fat. The procedure is quick, simple, minimally invasive, safe, highly effective, and while it is not cheap, it is less expensive than conventional surgical and pharmaceutical therapies which may not be effective at all. The first stem cell extraction and transplant for a dog typically run between $2,500 and $3,500, although the second transplant will often cost much less since extraction is only necessary once. The entire stem cell extraction procedure consists of the approximate equivalent of 2 to 3 tablespoons of the animal’s own adipose (fat) tissue which is surgically removed under anesthesia and shipped overnight to Vet-Stem’s laboratories in southern California where the stem cells are processed and returned two days later to the veterinarian who injects the stem cells back into the animal. Not only do the stem cells automatically target the injured tissue, but they also stimulate other endogenous stem cells which in turn are mobilized into action and participate in the healing and repair process. Although improvements are usually dramatic and immediate, even after the first injection, additional injections may be necessary, depending upon the age and condition of the animal. Very few animals ever need more than a total or 2 or 3 treatments, however, before they are fully restored to their natural, pain-free state of mobility – which contrasts sharply with conventional therapies such as most prescription medications which may need to be taken indefinitely, without ever producing any tangible signs of improvement and while even possibly causing further damage to the animal through dangerous side effects and other associated risks.

Vet-Stem uses exclusively adult stem cells, derived from each animal’s own tissue. Since the cells are autologous (in which the donor and recipient are the same animal), there is no risk of immune rejection. More specifically, the stem cells that are harvested in Vet-Stem’s procedure are mesenchymal stem cells, which are highly potent adult stem cells that are also found in bone marrow and umbilical cord blood. Numerous scientific and clinical studies have been published in the peer-reviewed medical literature detailing the regenerative properties of mesenchymal stem cells. No embryonic stem cells are ever used in Vet-Stem’s therapies, since embryonic stem cells are highly problematic in the laboratory, whether they are of human or non-human origin. Among other problems, the risk of teratoma (tumor) formation disqualifies embryonic stem cells for use as a clinical therapy, even in animals. Adult stem cells, however, do not pose such risks and are therefore rapidly accumulating a consistent history of successful clinical treatments in veterinary, as well as in human, medicine.

A number of companies throughout the world are replicating the procedure pioneered by Vet-Stem. It is fortunate – not only for Zack but also for his 2-legged friends who learn from his example – that such companies are able to conduct their business without the same burdensome federal legislation that continues to impede progress in human medical adult stem cell therapies in the United States.

(Please see a number of other related news article on this website, which include but are not limited to the most recent one entitled, "Veterinary Stem Cell Therapies Translate into Human Therapies", dated July 14, 2009).

2009-07-15T00:00:00+00:00 July 15th, 2009|News, Osteoarthritis, Stem Cell Research, Stem Cells, Uncategorized|

Adult Stem Cells Treat Diabetes

Prochymal, the adult stem cell product derived from bone marrow and developed by Osiris Therapeutics, is currently in clinical trials for the treatment of type I diabetes. The double-blind, placebo-controlled, multi-site Phase II clinical trials have a target enrollment of 60 patients, each one of whom will receive 3 infusions over a period of 2 months.

Prochymal has been shown to protect the pancreas from the type of autoimmune attack that characterizes type I diabetes, thereby allowing the natural production of insulin. Patients in the trial have been able to reduce the amount of externally administered and prescribed insulin as their pancreas begin producing its own insulin.

According to Dr. Aaron Vinik of the U.S., "This is a very exciting discovery. When people get told they have diabetes, it comes as a tremendous shock. They have to live with having to take insulin injections for the rest of their lives. In the future, we will have a cure that will stop the disease in its tracks."

Prochymal is a proprietary adult stem cell product, the active ingredient in which is mesenchymal stem cells (MSCs) that are derived from healthy adult volunteer donors and formulated for intravenous infusion. Embryonic, fetal, and animal tissue are not involved. Prochymal has already been tested in over 1,000 patients in previous clinical trials with no adverse side effects.

In addition to these Phase II clinical trials for type I diabetes, Prochymal is also currently in Phase III clinical trials for graft-versus-host disease (GvHD), Crohn’s disease, and it is being developed for the repair of cardiac tissue following a heart attack as well as for the repair of lung tissue in patients with chronic obstructive pulmonary disease (COPD). Prochymal is the only stem cell therapeutic product currently designated both by the FDA and by the European Medicines Agency as both an Orphan Drug and as a Fast Track product. Osiris is also developing another adult stem cell product, Chondrogen, which is currently in clinical trials for the treatment of osteoarthritis of the knee.

A leader in adult stem cell therapies, Osiris Therapeutics is focused on the development of products for the treatment of inflammatory, orthopedic and cardiovascular diseases. In November of last year, Osiris formed a strategic alliance with the biotech company Genzyme that was valued at over $1.3 billion. In 2007, the two companies were awarded a $224.7 million contract from the U.S. Department of Defense for the development of Prochymal in the treatment of radiation sickness. (Please see the related news article on this website, entitled, "Genzyme and Osiris Form Adult Stem Cell Mega-Partnership", dated November 5, 2008).

2009-06-29T00:00:00+00:00 June 29th, 2009|News, Osteoarthritis, Stem Cell Research, Stem Cells, Uncategorized|

Cornell Conducts Adult Stem Cell Study on Horses

Researchers at the College of Veterinary Medicine at Cornell University in Ithaca, New York have reported the effective treatment with an autolgous adult stem cell therapy of tendonitis in horses.

Led by Dr. Alan J. Nixon, the study was not so much a "clinical trial" in the ordinary sense of the term, but was perhaps more correctly an "experimental study", since the researchers sacrificed the horses at the end of the evaluation period in order to conduct thorough histological and mechanical analysis of the tendons.

In the study, the researchers artificially induced tendonitis in the superficial digital flexor tendons (SDFT) of both forelimbs of an undisclosed number of horses. Six days later, autologous mesenchymal stem cells (MSCs) were then derived from the bone marrow of each horse, expanded and injected into one of the SDFT lesions, while the other untreated, "control" limb received an injection of 1 milliliter of saline. The MSCs were also gene-enhanced with IGF-1 (insulin-like growth factor 1), which has been demonstrated to stimulate cellular proliferation and tendon fiber deposition in the core lesion of tendonitis. Ultrasound examination of the tendons was performed at the start of the trial as well as at 2, 4, 6 and 8 weeks after administration of the therapy. According to an online abstract, "the horses were euthanized at 8 weeks and SDFTs were mechanically tested to failure and evaluated for biochemical composition and histologic characteristics."

As Dr. Nixon explains, "The biochemical composition of the treated and untreated tendons were similar 8 weeks after treatment. However, tendons injected with the stem cells had significantly improved histology scores, indicating a more normal microscopic appearance in treated tendons than untreated tendons. Nonetheless, more research is needed regarding the optimal dose of stem cells and the use of gene enhancement techniques to augment the observed benefit before making this technology clinically available."

The researchers conclude, "These findings indicate a benefit to the use of MSCs and AdIGF-MSCs for the treatment of tendonitis."

The results of the trial will be published in an upcoming edition of the Journal of Orthopedic Research in an article entitled, "Mesenchymal stem cells and insulin-like growth factor-1 gene-enhanced mesenchymal stem cells improve structural aspects of healing in equine flexor digitorum superficialis tendons."

Tendon injuries are often catastrophic and fatal in horses, while even minor tendon injuries can end the career of a race horse. According to Dr. Nixon, "At present, few successful treatment options exist for horses with tendon injuries. While stem cell therapy has become a hot topic in equine medicine, there are few controlled studies clearly documenting the safety or efficacy of this treatment modality for tendonitis in horses."

If killing the horse is a requirement for conducting a "controlled" study, then most people would probably conclude it’s a good thing that there aren’t many controlled studies that have been conducted.

In fact, a number of companies throughout the world are already treating horses, as well as other animals, with autolgous adult stem cell therapies, and not only do the animals improve as a result of the therapy but the animals are also allowed to continue living and enjoy the remainder of their lives. Perhaps the most renowned of these companies is the U.S.-based Vet-Stem, which has treated over 3,000 horses and 2,000 dogs with autologous adult stem cell therapy for a variety of joint injuries and degenerative conditions that include tendonitis as well as ligament injuries and age-related osteoarthritis. None of the animals treated by Vet-Stem’s autolgous adult stem cell therapy ever had to be euthanized, but instead were allowed to live out their natural lives.

Additrionally, in September of 2007 Vet-Stem licensed their proprietary adult stem cell technology to the Central Veterinary Research Laboratory (CVRL) of Dubai in the United Arab Emirates, thereby allowing the CVRL to offer the same adipose-derived adult stem cell animal therapies throughout the Middle East. Sheik Mohammed bin Rashid al-Maktoum, the ruler of Dubai and the Prime Minister of the UAE, is an avid thoroughbred owner and a sponsor of the Dubai World Cup, the world’s most highly-prized horse race. As Vet-Stem founding CEO Dr. Harman described in 2007, "The Central Veterinary Research Laboratory will be an excellent partner in bringing this technology from the U.S. to the Middle East as they are already the most respected reference lab in the region." CVRL now provides stem cell services for the treatment of injuries not only in thoroughbred race horses and Arabian endurance horses, but also in racing camels, among other species, throughout the Middle East.

It is actually incorrect, therefore, to claim that "there are few controlled studies clearly documenting the safety or efficacy of this treatment modality for tendonitis in horses", since more than 3,000 case studies have been documented by Vet-Stem alone, not counting the other case studies conducted around the world by other companies that are performing similar therapies in other countries. It is also incorrect to claim that "more research is needed regarding the optimal dose of stem cells and the use of gene enhancement techniques to augment the observed benefit before making this technology clinically available", since, actually, such technology is, in fact, already clinicallly available.

Given the consistent success of such therapies as those used by Vet-Stem, one might seriously question the wisdom and necessity of conducting "controlled studies" in which the horses must be killed at the end of the study in order to determine the efficacy of the medical therapy. Horses are not generally bred and maintained in the same manner as laboratory mice, although in this Cornell study, one might easily get the impression that the two animals are interchangeable.

Ordinarily, veterinarians, like all physicians, measure the efficacy of a therapy by the ability of the patient to recover – not by killing the patient in order to examine the mechanical, biochemical and histological properties of the tissue that was treated. Such an approach to medical therapy would be considered entirely unacceptable in humans, and even in horses the concept seems to lack basic horse sense.

2009-04-25T00:00:00+00:00 April 25th, 2009|News, Osteoarthritis, Stem Cell Research, Stem Cells, Uncategorized|

Osiris Begins Phase II Clinical Trial With Adult Stem Cell Therapy for the Treatment of Heart Attack

Deep in the heart of Texas, the Heart Hospital of Austin is one of approximately 40 hospitals throughout the United States and Canada that have been chosen to participate in an FDA-approved clinical trial for the use of adult stem cells in the treatment of heart attack patients.

Specifically, the double-blind, placebo controlled Phase II clinical trial will evaluate the efficacy of an allogeneic adult stem cell product developed by the biotech company Osiris Therapeutics. Known as Prochymal, this proprietary adult stem cell therapy has already demonstrated exceptionally strong safety results in the Phase I clinical trial, during which time Prochymal was found to be even safer than a placebo. The current Phase II clinical trial will evaluate the ability of Prochymal to regenerate damaged heart tissue following a heart attack. The first patient to be enrolled in the clinical trial, a 58-year-old male, was already treated on Monday, within days of his heart attack. Approximately 20 patients will be enrolled in the study over the next 6 to 8 months, all of whom will receive the Prochymal treatment within 7 days of having suffered a heart attack. Prochymal is administered intravenously, and the entire therapy takes less than an hour to complete. Of the 40 hospitals that are participating in the clinical trial, only the Heart Hospital of Austin and one other hospital, in Kansas, have already begun treating patients.

According to 74-year-old Miles Simmons, who is also enrolled in the study in Austin and is scheduled to receive the Prochymal therapy, “I have a lot of grandchildren and I love them and I would like to spend more time with them. I think it’s wonderful. If you have technology, then use it.” As Dr. Roger Gammon, a cardiologist with the Heart Hospital of Austin and the director of the clinical trial, explains, “It would change everything for people with heart attacks. Research in this area has just exploded, and a lot of funding is going to have to come from the government to really push it forward. What’s kind of unique and new is it’s given intravenously. The cells are drawn to the heart and they implant there. If it works, it will be fantastic.”

Prochymal is composed strictly of adult stem cells, not embryonic stem cells. More specifically, Prochymal is composed of mesenchymal stem cells that are derived from the bone marrow of healthy adult donors. As such, not only is Prochymal entirely removed from the ethical controversies surrounding embryonic stem cells, but Prochymal is also free of the numerous medical risks posed by embryonic stem cells, not the least of which is the strong natural tendency of embryonic stem cells to form teratomas (tumors), which all pluripotent stem cells must, by definition, be able to form. By sharp contrast, since adult stem cells are not pluripotent, they are incapable of forming teratomas and do not pose such risks. Even though Prochymal is composed of non-autologous, allogeneic (in which the donor and the recipient are not the same person) adult stem cells, there is no risk of immune rejection since mesenchymal stem cells have been proven in multiple studies to be “immune privileged”, “universal donor” cells.

Nevertheless, embryonic stem cells remain a contentious issue, and on Friday of this week the Texas State Senate is scheduled to debate the topic of funding for embryonic stem cell research. According to Republican Senator Tommy Williams, “I think people agree that there’s the potential for moral hazard here, and so I think it’s important to give our state agencies and research institutions guidance.” The Texas state budget was passed on Wednesday, but no state funds will be used for embryonic stem cell research until the Legislature sets a policy.

Meanwhile, adult stem cell products such as Prochymal eliminate any need for debate. In a similar type of clinical trial, a hospital in Houston is also using adult stem cells for the repair of neurological tissue in stroke patients.

As Dr. Gammon adds, “We are excited to be the first to treat a patient in this groundbreaking study and to lead the way in this important research. Austin Heart and the Heart Hospital of Austin were selected because of their proven history of excellence in cardiovascular research and strong performance in the earlier Phase I trial. There’s a lot of enthusiasm in the cardiovascular community about the potential of stem cell therapies for treating heart disease. Earlier studies have established confidence in the safety of the therapy, but more research is needed to study its effectiveness.”

Osiris Therapeutics is the leading stem cell therapeutic company in the world, involved in the research and development of therapeutic products that are based exclusively upon adult stem cells, not embryonic stem cells. Osiris was founded in 1992 and went public in 2006. Its products focus on the treatment of inflammatory, orthopedic and cardiovascular conditions. The company’s proprietary adult stem cell product Prochymal is the only stem cell therapeutic product currently designated by the FDA as both an Orphan Drug and as a Fast Track product. In addition to the current Phase II clinical trial for the regeneration of cardiac tissue following myocardial infarction, Prochymal is also in Phase II clinical trials for the regeneration of pancreatic beta islet cells in patients with Type I diabetes and for the repair and regeneration of damaged lung tissue in patients with chronic obstructive pulmonary disease. Prochymal is also currently being evaluated in three separate Phase III clinical trials, two of which are for graft vs. host disease (GvHD) and the third of which is for Crohn’s disease, both of which are potentially fatal conditions. Additionallly, the company’s adult stem cell product Chondrogen has also been approved to begin Phase II and III clinical trials for osteoarthritis of the knee. Osiris currently has 47 U.S. patents, each with one or more foreign counterparts. In 2008 Osiris formed a strategic alliance with Genzyme worth approximately $1.3 billion, and that same year the U.S. Department of Defense awarded Osiris a contract to develop Prochymal as a treatment for acute radiation syndrome.

The Heart Hospital of Austin has been ranked the number one leading hospital in Texas for overall cardiac services for 6 years in a row, since 2004, during which time it has also ranked among the top 5% of hospitals in the nation for overall cardiac services, and in 2009 it was also chosen as number one among hospitals in Texas for cardiac surgery.

2009-04-01T00:00:00+00:00 April 1st, 2009|News, Osteoarthritis, Stem Cell Research, Stem Cells, Uncategorized|

Stem Cell Therapies Go to the Dogs, Horses and Camels

In his profession, job-related injuries are common. So when Buzz, a 3-year-old male Border Collie, was recently injured in his job, it looked as though his career was over. Responsible for the herding of sheep on a 40-acre working farm near Ramona, California, Buzz was faced with surgery and a recovery period of at least 6 months after rupturing a kneecap tendon. According to his owner, John Doyle, “His career was over. He was through.”

However, after undergoing the surgery to repair his tendon, Buzz then also received 3 rounds of autologous adult canine stem cell therapy. Instead of having to endure a 6-month recovery period, Buzz returned to work a mere 6 weeks after receiving the stem cell treatment. As Mr. Doyle explains, “In 2 weeks, you could see that he was healing very quickly. He was able to do a lot more.”

As previously reported a number of times on this website, the California-based company Vet-Stem is demonstrating consistent veterinary success in the treatment of animals with autologous adult stem cell therapy. Although Vet-Stem was the first company to commercialize the process, a number of other companies throughout the world are now also utilizing the same type of technology, in which adult stem cells are derived from each animal’s own adipose (fat) tissue and readministered to the animal as a clinical therapy for the particular medical condition from which the animal suffers. This type of autologous adult stem cell therapy has proven to be a highly preferable alternative treatment for many animals, especially those whose conditions require surgery or anti-inflammatory drugs, both of which can often be avoided with the stem cell therapy.

Vet-Stem was founded in 2002 as the result of stem cell research conducted at the University of Pittsburgh and UCLA in the late 1990s, when Dr. Bob Harman saw the commercial potential for veterinary applications of such stem cell technology. A veterinarian himself, as well as a statistician and former biotech entrepreneur who had already held the top executive title at 3 biotechnology companies prior to Vet-Stem, Dr. Harman is now the CEO of Vet-Stem as well as one of its founders. Based in San Diego, Vet-Stem patterned its initial clinical model upon the example of other companies that were already involved in human adult stem cell therapies, such as Cytori Therapeutics which had developed a proprietary separation apparatus that harvests human adult stem cells from adipose tissue at the patient’s bedside during reconstructive or cosmetic surgery. In a similar procedure, veterinarians extract approximately 2 tablespoons of adipose tissue from each animal, which are then sent to Vet-Stem where the adult stem cells are isolated, purified, expanded and returned within 48 hours to the veterinarian who then administers the stem cells to the animal.

Dogs are not the only animals to benefit from Vet-Stem’s veterinary technology, as horses and other larger animals have also been found to respond very well to adult stem cell therapies. In fact, among other partnerships, in September of 2007 Vet-Stem licensed their proprietary adult stem cell technology to the Central Veterinary Research Laboratory (CVRL) of Dubai in the United Arab Emirates, thereby allowing the CVRL to offer the same adipose-derived adult stem cell animal therapies throughout the Middle East. Sheik Mohammed bin Rashid al-Maktoum, the ruler of Dubai and the Prime Minister of the UAE, is an avid thoroughbred owner and a sponsor of the Dubai World Cup, the world’s most highly-prized horse race. As Dr. Harman described in 2007, “The Central Veterinary Research Laboratory will be an excellent partner in bringing this technology from the U.S. to the Middle East as they are already the most respected reference lab in the region.” CVRL now provides stem cell services for the treatment of injuries not only in thoroughbred race horses and Arabian endurance horses, but also in racing camels, among other species, throughout the Middle East. In the United States Vet-Stem has already treated over 3,000 horses and over 2,000 dogs with joint injuries and degenerative conditions that include tendon and ligament injuries as well as age-related osteoarthritis. Vet-Stem’s overall success rate is around 80% in the number of animals who are able to return to normal performance, a rate that is significantly above that of conventional surgical and pharmaceutical therapies.

Ordinarily, injuries of the bones, joints, tendons and ligaments result in scarring of the tissue, which not only prevents full healing but also often leads to further injuries at a later time. Conventional medical therapies do nothing to address the problem of scar tissue directly, and surgical procedures actually make the problem worse by increasing the severity of tissue scarring which in turn merely exacerbates later complications that will inevitably result from the scar tissue, since such tissue can never be fully rehabilitated. Stem cell therapy, however, allows for the full and complete healing of tissue without scarring, which not only reduces the risk of re-injury of the same tissue at a later date but also restores full physical performance and function, usually very quickly and dramatically. Such is the case in humans as well as in animals.

In fact, as Dr. Harman explains, “Our success in animals is directly translatable to humans, and we wish to share our evidence that stem cells are safe and effective.”

Vet-Stem uses exclusively adult stem cells, derived from each animal’s own tissue. Since the cells are autologous (in which the donor and recipient are the same animal), there is no risk of immune rejection. More specifically, the stem cells that are harvested in Vet-Stem’s procedure are mesenchymal stem cells, which are highly potent adult stem cells that are also found in bone marrow and umbilical cord blood. Numerous scientific and clinical studies have been published in the peer-reviewed medical literature detailing the regenerative properties of mesenchymal stem cells.

No embryonic stem cells are ever used in Vet-Stem’s therapies, since embryonic stem cells are highly problematic in the laboratory, whether they are of human or non-human origin. Among other problems, the risk of teratoma (tumor) formation disqualifies embryonic stem cells for use as a clinical therapy, even in animals. Adult stem cells, however, do not pose such risks and are therefore rapidly accumulating a consistent history of successful clinical treatments in veterinary, as well as in human, medicine.

Vet-Stem was initially funded by Toucan Capital of Maryland, which invests in early-stage life sciences companies and which provided an initial one million dollars in seed funding to Vet-Stem as well as an additional five million dollars to date. As with the other biotech companies that Dr. Harman has directed, Vet-Stem promises to be a highly profitable and sound investment, not only for its financial investors but also for its four-legged patients.

2009-03-30T00:00:00+00:00 March 30th, 2009|News, Osteoarthritis, Stem Cell Research, Stem Cells, Uncategorized|