International Stem Cell Corporation (OTCBB:ISCO), and Sankara Nethralaya Eye Hospital, a nonprofit medical facility, announced commencement of a collaboration to develop ISCO’s ‘CytoCor™’ stem cell-derived corneal tissue. The goal is to use CytoCor to treat corneal blindness and vision impairment.

CytoCor consists of transparent human tissue derived from pluripotent human stem cells. These structures are produced in the laboratory and recent testing at Sankara Nethralaya and laboratories in the US has demonstrated a range of structural, biochemical and refractory properties characteristic of human cornea.
‘This is one more step in ISCO’s stated plan of building its portfolio of therapeutic agents through strategic alliances throughout the world,” said Chairman, Ken Aldrich.

CytoCor may offer a first-in-class opportunity for high-quality, cost-efficient transplantation tissue for the 10 million people world-wide suffering from corneal vision impairment, particularly in India and the rest of Asia, as well as in Europe. Standardized tissues derived from pluripotent stem cells, such as the CytoCor tissue, could eliminate the current problem that corneal tissue derived from donors may harbor diseases that could be transferred from the donor to the recipient. It may also provide a much needed alternative to the use of live and extracted animal eyes in the $500+million market for safety testing of drugs, chemicals and consumer products.

According to Professor Dr. S. Krishnakumar, “Sankara Nethralaya is dedicated to the development and application of new state-of-the-art ophthalmic technologies. The need for high-volume, high-quality human corneal tissue is substantial, not only in India but across Asia and much of Europe. We appreciate the opportunity to join ISCO in their pursuit to create a new standard of care for the treatment of human corneal disease.” Initially, Dr. Krishnakumar and his team will be using the CytoCor tissue in preclinical studies to explore the ability of the tissue to withstand sutures and bio-compatible glues in order to validate the potential of the tissue for use in animal or human clinical trials.

According to Dr. Geetha Krishnan Iyer, who is involved in the management of ocular surface disease at Sankara Nethralaya, ‘The team at Sankara Nethralaya is pleased to collaborate with ISCO on stem cell-derived corneal tissue. In vitro studies to evaluate safety and efficacy of the tissue, as well as surgical feasibility tests will be carried out, following which there could be clinical application in lamellar keratoplasty using the above mentioned tissue. With improvements in surgical techniques over the past few years, the indications for anterior lamellar keratoplasty have expanded significantly. With high demand for donor corneal tissue for the same but limited availability, there is definitely scope for utilizing ISCO’s corneal tissue following relevant tests.”

Jeffrey Janus, Senior VP of Operations at ISCO, states: ‘This collaboration with the excellent team of scientists and clinicians at Sankara Nethralaya has already proven to be productive. Sankara’s ophthalmology expertise and ISCO’s cell culture capabilities constitute a perfect match to perfect and advance CytoCor tissue towards future use in treating corneal disease and injuries.”

About International Stem Cell Corporation (ISCO.Ob):
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike all other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals across racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology and is developing a line of cosmeceutical products via its subsidiary Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available at ISCO’s website.

About Sankara Nethralaya
Sankara Nethralaya was founded as a not-for-profit eye hospital in Chennai, India, in 1978. This mission of “non-commercial medicine” has continued until today when the organization has expanded its clinical practice to many regions of India and grown into a superior specialty institution for ophthalmic care and world-leading eye research. Sankara Nethralaya’s hospitals see 1,600 eye patients and do over 100 eye surgeries each day, often free to the patients.

For example, in its main Chennai operating center, about 15,000 cataract surgeries are performed free of cost each year, amounting to 50% of all cataract surgeries done in Chennai the complex. On the research side, Sankara Nethralaya employs sixty scientists and clinicians dedicated to the basic and applied research and development and application of new state-of-the-art ophthalmic technologies. Sankara Nethralaya is serious about both reach and quality, e.g. they have trained over 300 ophthalmologists all over India and they were the first ISO 9002 certified Eye Hospital in Asia.

FORWARD-LOOKING STATEMENTS
Statements pertaining to anticipated technological developments and therapeutic applications, the potential benefits of collaborations, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.

Imogen James

Little Imogen James’s parents hope their daughter will finally be able to see them after the two-year-old almost died at birth and was left almost totally blind.

Nick, 30, and Lauren, 25, James are raising thousands of pounds which will allow Imogen to undergo pioneering stem-cell surgery at a clinic in China.

Imogen almost died at birth and spent 10 days in the special-care unit at Yeovil District Hospital. She survived against the odds but was diagnosed with optic nerve hypoplasia, which prevents this nerve from forming completely while the baby’s in the womb. She is almost entirely blind and also has reduced mobility as a result of low muscle tone.

Imogen’s parents, of Yeovil, have been told by doctors in the UK there was no treatment that could help. However, Mr and Mrs James found hope for a brighter future for their daughter after learning about a clinic in China that is pioneering stem-cell treatment.

Inspired by the case of Northern Ireland toddler Dakota Clarke, who they visited in April and who is showing signs of improved faculties after surgery at the Chinese centre, they have launched a campaign to raise the nearly £30,000 needed for the treatment.

They are already nearly halfway towards their target and this week booked their flights to China for December. They will spend a month with medical firm Beike Biotechnology, whose treatment centre is at Zhejiang Xiaoshan Hospital in Hangzhou. During six treatments, stem cells extracted from donated umbilical cord blood will be inserted into Imogen’s head. The surgery may allow her to see and make it possible for her to walk and to stand on her own.

Mr James said: “This has given us hope, because even a one per cent increase in her vision would improve her standard of life tremendously. The authorities in the UK say it does not fully cure the condition, but we went to see Dakota in Northern Ireland and she now has some vision, and there is a teenager in America that has now passed her driving test after receiving the treatment.”

As the world leader in stem-cell techniques, China has been mired in controversy over claims of lax ethical standards regulating research. But the family said they were prepared to do whatever it took to improve Imogen’s quality of life.

Mr James, an aircraft engineer with the Royal Navy, said: “When we first found out about the possibility of stem-cell treatment, we wanted to find out more but were still undecided. But after seeing the improvements in Dakota we knew this was definitely the way ahead and we made our decision at the end of April.”

About six months ago the family moved to Scotland, but they are returning to Yeovil to live in Houndstone in a couple of weeks’ time.

Mr James, who will again be based at RNAS Yeovilton, said the main motivation for the family’s return was the care available for Imogen and that it was likely he would remain at the airbase for the rest of his career. He said: “Imogen used to attend the Balidon centre in Yeovil for special-needs children, but there is no provision like that here. She came on so much when she attended and has really missed it, and we know we are doing the right thing in coming back,” he said.

Their first fundraising event locally will see local band Storm in a gig at the Crown & Victoria in Tintinhull on Sunday, September 20. Collection tubs will be around the town, and Mr James is planning to run the half-marathon at the Eden Project in October. Several other events are in the pipeline.

“We have come up with a few different ideas to raise the money and have had a lot of support for our fundraising campaign in Scotland, and hope to be able to continue this when we return to Yeovil,” he said.

The couple also have a son called Dylan, who is eight months old and was born healthy. He has already developed well beyond his elder sister’s capabilities, as she finds it impossible to crawl without assistance. Imogen will celebrate her third birthday on Friday, July 28.

Mrs James, who left her job in the navy to look after Imogen, said: “Although the operation is not some miracle cure, it could be the difference between Imogen reading Braille or large print.

“It will cost a huge amount of money, so any donation, large or small, will make a massive difference to Imogen’s life.”

For more information, visit www.helpimogensee.org. Donations can also be made through the Royal Bank of Scotland fundraising account, sort code 83-15-15 and account number 00315310.

DENVER – He was given a hero’s welcome at DIA Wednesday after being wounded in Iraq two years ago. Today, he sat down for a one on one with us, in the hotel where his family is staying.

Marine Lance Corporal John T. Doody with his mother and stepfather. (July 16, 2009)

26 -year-old Marine Lance Corporal John Doody, J.T. to friends and family, was given little chance to live by military doctors.

“To get up out of my bed is hard…because I got shot…I have a disability,” JT told us in short sentences.

His mother and stepfather abandoned their jobs and have dedicated their lives to see him fully recover.

“He is a miracle. He’s defied all of the medical odds so far,” said his mother Chris Ott. “And it’s due to faith it’s due to a positive attitude.”

A blood infection from three gunshot wounds suffered in Iraq in 2007 left Doody’s brain severely damaged; his body racked with spasms. Now, besides giving around-the-clock care and rehab, his mother is fighting for other vets like him on several fronts.

“The media thrives on other things and these guys get put on the back pages,” said Chris. “And then nobody sees them, nobody remembers them. We’ve still got casualties every day,” Ott told us.

“The most important thing that I want the people of Colorado and the nation to know is that we can’t forget about these guys,” she said.

“They forgot about us. They shouldn’t have,” said J.T.

J.T. is often in pain and during our interview he had several episodes, but he keeps his since of humor. “It’s hard work living up to this Purple Heart. (It) means I got shot,” he half-joked. He says he’d like to be a lawyer some day.

J.T.’s mom wants more funding for better rehabilitation equipment for injured veterans. She even took J.T. out of country for stem cell therapy.

“There’s no doubt in mind that those stem cells helped,” she said, “We definitely need to step up the research and get these folks the help that they need. ”

She says many wounded vets are not as lucky as her son, and wants to share his continued recovery to get them more help.

“I do believe that in a lot of ways that the people have forgotten our young men are out there,” Chris told us with resignation in her voice.

“You guys can’t forget about us….because we haven’t forgot about you,” J.T. added, after a long pause.

The family has started a website where you can follow his story and find out where you can help him and other veterans.

http://www.helpjt.com/

A public reception for Doody for will being held this Saturday at the Hampton Inn in Brighton, from 2 to 6pm.

Adult stem cell therapy, with roots tracing back to bone marrow transplants in the ’50s, is coming into its own. Available outside the USA for several years now, an ever-growing body of US residents travel to abroad to receive these treatments.

Feel free to browse this site to learn, connect and explore.

Last Updated on Friday, 17 April 2009 09:36

The Colorado Stem Cell Awareness Rally has been scheduled for June 13th, 2009 in Denver Colorado!

Location: Denver Colorado
Place: Stella’s Coffee House/Platt Park Center
Date: June 13, 2009
Time: 2pm
Contact: Shel Morse

Contact Shel Morse to register or for more information.

All are welcome! Click “Read More” for more details.

The event will be held at Stella’s Coffee House which is located at:  

1476 S. Pearl St.
Denver, CO 80210
p: 303.777.1031

A map can be found on Mapquest by clicking here.

Attending Physicians:

Dr.Klein
Dr. Hakim
Dr. Schultz (from Regenexx)
Representatives from Colorado Stem Cell Clinic www.regenexx.com

Guest Speakers:

Katie Corkern – Cerebral Palsy                                                                               
Tami Cosby – ONH
Don Margolis

Govender together with the staff of The Rising Sun Newspaper hosted a fundraising drive last year during which funds were raised to send baby Shirdesh, who was blind at the time, for stem cell treatment in China. Now baby Shirdeshhas signs of vision. Govender is seen  together with Bruce Sturgeon, CEO of the Caxton Group of Newspapers and Vijay Maharaj, CEO of The Rising Sun Newspaper Group.

“The Safe Stem Cells NOW movement was started by the American Stem Cell Therapy Association. The goal is to let patients know that their ability to access safe stem cell treatment is being heavily restricted by the big pharmaceutical giants and the FDA.”

Visit Safe Stem Cells NOW’s webpage to learn more.

Within the next five years, it’s quite possible that physicians will come into routine possession of a remarkable set of tools — a brand new way of dealing with the frailty and disabilities of aging. The tool kit is autologous stem cells derived from the patients themselves, amplified in culture, and infused back into the patient according to a precise protocol. It would be such a leap from today’s medical diagnostics and treatments; it could only be called revolutionary.

The purpose of employing autologous cells is to prevent rejection of histo-incompatible cells by the patient’s immune system. But it’s also possible that these new therapies could slip from our grasp, at least in the US. If we’re not careful, these therapies could become the exclusive domain of the pharmaceutical industry, as regulated by the Federal Food and Drug Administration (FDA). This could push the availability of this tool kit 15 to 20 years into the future. The opportunity-cost in terms of morbidity and mortality could be catastrophic.

Dr. Christopher J. Centeno, M.D., is an expert in this field, having spent four years performing an autologous, minimal culture-expansion technique in orthopedics that use adult mesenchymal stem cells. Known as the Regenexx™ procedure, it uses a patient’s own stem cells and hematogenous growth factors to regenerate bone and cartilage. At Regenerative Sciences, Inc. (where he also serves as Lab Director) and CentenoSchultz Clinic in Broomfield, CO (run with Co-Medical Director John R. Schultz, M.D.), the focus is on development of this non-surgical option for people suffering from a variety of orthopedic conditions. L. Stephen Coles spoke with Dr. Centeno for h+.

“The cell-therapy industry right now is very nascent; it’s where age-management was ten years ago,” he told me. Dr. Centeno has established an organization to define guidelines and standards called The American Stem Cell Therapy Association (ASCTA). “We’re trying to develop physician guidelines in the U.S. for the safe use of stem cells, similar to the way fertility clinics operate. We’ve got an organization to formulate guidelines, and we’ve got clinicians working to form a stem-cell registry. But the FDA doesn’t appreciate that. We only do adult cells from the same person. But the FDA contends that if one cultures stem cells at all, regardless of the use of those cells, then it’s a prescription drug.” He points out that the age-management community has seen many instances where the FDA has tried to insert itself into the practice of medicine — although this has been strictly prohibited by Congress — and this is just the latest. “Compounding pharmacies have been coming under FDA pressure for a long time, and have now organized and set up their own standards and guidelines as a way to combat that interference.”

Dr. Centeno compares the current state of stem-cell medicine to that of fertility treatments. “If you’re an infertility specialist, you have to grow a woman’s fertilized oocytes at least to the blastocyst stage before implanting them, and the FDA has no control over that. If the FDA had gained control, you wouldn’t have individual fertility practices — instead you’d have just a few big labs across the country.” Instead of being regulated by the FDA, fertility doctors are regulated state-by-state. The reason, says Dr. Centeno, is simple: “They organized, put their own standards in place, and created a case, saying, ‘Listen, this is the practice of medicine, and you, by charter, are not allowed to regulate the practice of medicine.’”

“You’re talking about replacing $60 billion in drug- and device-care with $6 billion in stem-cell care,” Dr. Centeno observes.

Prior to becoming involved in stem-cell research, Dr. Centeno was already an international expert and specialist in musculoskeletal, spinal, and neurologic injury. Having trained at the Baylor College of Medicine, Texas Medical Center, and the Institute for Rehabilitation Research, he is an M.D. who is double-boarded in Physical Medicine and Rehabilitation as well as Pain Medicine. Dr. Centano has seen the results that are achievable in an orthopedic context. “We’ve done this for four years for patients with orthopedic conditions. So, as a test case, we know it can work safely and effectively.”

To Dr. Centeno, it is inconceivable that a person’s own cells could be classified as a drug — but that’s exactly what the FDA wants to do. “The FDA is working to protect the interests of Big Pharma,” he says. “If we wanted to insert some kind of new genes into these cells, we might all agree that could be a drug — a new entity. But what we’re doing is simply culturing a person’s own cells. Most of the cells are bone-marrow derived; you can get them from synovial fluid in the knee or from other locations.” Basically, there are three main types of adult stem cells:

1. Mesenchymal stem cells are commonly found in the bone marrow. These cells can differentiate into multiple orthopedic, neural, organ, and other lineages.
2. Very Small Embryonic Like Cells (VSEL) are a newer stem-cell line and more likely to have the ability to differentiate into multiple cell types and lineages.
3. CD34+ heme progenitors are usually derived from bone marrow and can be mobilized into the bloodstream. They have been used commonly in vascular and cardiac applications.

Most importantly, the mesenchymal cell line alone — the one Regenexx has been using — has more than 8,000 peer-reviewed citations showing its wide application in age-management medicine, including the treatment not just of orthopedic conditions, but of Type-II Diabetes, stroke, and cardiovascular disease. “It can be used to treat everything from cardiac disease after a heart attack, to vascular disease, to orthopedic injuries,” notes Dr. Centeno.

As we move beyond “Regenerative Medicine 1.0” ­- which is where Dr. Centeno sees things currently: “I suspect what will happen, in 2.0, is that you’ll see some age-management-medicine doctors start their own regenerative stem-cell lab, take cells derived from a patient, minimally culture them, and then they can be deployed.” For instance, in cases of diabetes, the cultured cells would be injected under CT or ultrasound guidance directly into the Islets of Langerhans in the pancreas. There, according to Dr. Centeno, “in animal models, they routinely cure diabetes.”

It’s important to note that, while the recently lifted ban on embryonic stem-cell research federal-funding by President Obama on March 9th has helped to focus attention to the whole subject of stem-cell-based therapies, including iPSC’s (induced Pluripotent Stem Cells derived from a skin biopsy), the work that ASCTA does is exclusively linked to ‘adult’ stem cells… and the patient’s own stem cells at that. “A large number of diseases have already been looked at,” notes Dr. Centeno; “The basic research is already in place.” As presented in a “list-in-progress” on the ASCTA website, areas involved in ongoing research on the use of adult stem cells in disease treatment clearly overlap with areas of embryonic stem-cell research:

* ALS (Amyotrophic Lateral Sclerosis) or Lou Gehrig’s Disease
* Alzheimer’s Disease
* Parkinson’s Disease
* Multiple Sclerosis
* Muscular Dystrophy
* Osteoarthritis
* Rheumatoid Arthritis
* Spinal-Cord Injury
* Stroke

In terms of treating age-related conditions, Dr. Centeno sees stem-cell therapies as an entirely new level of medicine. “In 1.0, we use hormones,” he explains. “Treating using hormones is great, but at some point the parts wear out and that’s where 2.0 comes in.” As an example, Dr. Centeno cites a study that was just presented at the American College of Cardiology Conference in Orlando, FL, showing a dose-response relationship on repairing the heart after an Acute Myocardial Infarction, with improved heart function after stem-cell injection.

On March 31, 2009 HealthDay News reported on a U.S. study that found that “treating a heart attack with the patients own bone-marrow stem cells boosts blood flow within the heart and may help reduce long-term complications.” The study included 31 patients who underwent angioplasty and stent placement after a heart attack. Within one week of the attacks, 16 of the patients received infusions of their own bone-marrow cells into the coronary artery in which a blockage had caused the event.

The 16 patients received different amounts of bone marrow stem cells — 5 million, 10 million, and 15 million cells. The 15 patients in the control group received standard medication only. All the patients were followed for up to five years. “After three to six months, patients who received higher doses of bone-marrow stem cells showed greater improvement in blood flow within the heart than patients who received lower doses and those in the control group,” the researchers said.

In a news release, Principal Investigator Dr. Arshed Quyyumi, a Professor of Medicine at Emory University School of Medicine said: “This is critical information for future study design — the more cells a patient receives, the more beneficial effect we see in the heart,” The researchers also found that higher doses of bone-marrow stem cells appeared to help cardiac function, as determined by measuring the percentage of blood pumped out with each heartbeat (Ejection Fraction), and by measuring the amount of tissue death (infarction) due to inadequate blood supply. However, these results were not considered statistically significant, the researchers stressed.

“These results show that treatment with a patient’s own bone-marrow stem cells has the potential to reduce long-term complications after a heart attack. We are encouraged by these results and are planning to conduct a more extensive study,” Quyyumi said.

“Until now there was no way to treat that,” observes Dr. Centeno. “Obviously, if you are a heart specialist or cardiologist this is of big interest to you.”

One key to treatments using a patient’s own stem cells is to gather and bank those cells in advance. “The number available for treatment declines with age,” Dr. Centeno points out.

“In a 60-year-old person we might get 60,000; we can grow that in a lab to a million, which is enough to treat a condition. It’s what the body does, but the body can’t always get a sufficient number to the right place at the right time. If someone enters your practice at 40, just starting to see the consequences of aging, you would remove those cells and freeze them.” Though this sounds relatively simple, the prospects for such treatments in the future rest squarely on developing industry standards in the near term. “There are already companies doing that stem-cell freezing,” Dr. Centeno notes. “The problem is that if the FDA has its way, nobody will be able to use those cells because they will be considered a prescription drug. You won’t be able to use them in any meaningful way; you must incubate them to get them out of the cryogenic state because it’s a delicate process” ­- and that’s what the FDA considers ‘turning the cells into a drug’.

Thus, while development of stem-cell standards and guidelines is a work in progress, it is one about which there is a real sense of urgency. “All of this could be done within the next 12 months; we could have hundreds of people across the country doing this work under the ASCTA Guidelines,” explains Dr. Centeno. “We could get out of the starting gate very quickly if everyone gets on board; otherwise, the window is going to shut and it will never happen.”

The stakes for the pharmaceutical industry are obviously also high. “You’re talking about replacing $60 billion in drug- and device-care with $6 billion in stem-cell care,” Dr. Centeno observes. The end result will either be individual physicians owning and controlling labs, or, says Dr. Centeno, “It will all be controlled by Big Pharma, and innovation will move at a snail’s pace.”

Interview with Dr. Christopher J. Centeno, M.D
By L. Stephen Coles, M.D., Ph.D., Visiting Professor of Computer Science UCLA School of Engineering for h+ Los Angeles, California

Dr. Centeno is an international expert and specialist in musculoskeletal, spinal, and neurologic injury. He is an M.D. who is double-boarded in both Physical Medicine and Rehabilitation, and in Pain Medicine. He trained at the Baylor College of Medicine, Texas Medical Center, and the Institute for Rehabilitation Research. Dr. Centano utilizes a traditional medical approach blended with alternative and research-based treatments. He is Medical Director of The Centeno-Schultz Clinic and the Spinal Injury Foundation, and Scientific Co-chair of the International Whiplash Trauma Congress, which draws scientists together from all over the world. He is Co-Editor-in-Chief of the new peer reviewed medical journal, Whiplash and Related Disorders published by Haworth Medical Press, as well as the author of the medical text, The Spine Dictionary. Dr. Centano practices in Denver, North Denver, and Boulder, Colorado.

L. Stephen Coles, M.D., Ph.D., is Co-Founder 
Los Angeles Gerontology Research Group

h+: When did you begin your clinical work on adult stem-cell therapeutics?

CHRISTOPHER CENTENO: I started in 2005, and the very first question I had to address was whether I needed approval from the FDA to infuse autologous culture-expanded stem cells derived from patient tissue back into that same patent or whether such procedures ought to be considered part of the normal practice of medicine. We obtained opinions from three different attorneys. Their opinion was that what we’re doing was, in fact, “the practice of medicine,” so the FDA had no jurisdiction. The FDA recently has asserted that it’s their belief that autologous stem cells are the equivalent of a prescription drug. But this is a position we dispute.

h+: Does that mean that the FDA could consider a patient’s own cells — when infused back into the patient — as a “prescription drug” that would fall under their regulatory guidelines, requiring a full set of Phase-I, -II, and -III Clinical Trials that could take five years or more and cost millions of dollars?

CC: Yes, that’s right. And it’s even more complex than that. If the procedure were done in the physician’s office, but done over more than one day, then the FDA could claim that they should have jurisdiction, since the cells would then be considered a drug according to their perspective. When a federal agency is looking to expand its charter (the scope of activities it seeks to regulate), it may well infringe on the practice of medicine unless doctors stand up for what is rightfully their practice.

h+: Has the FDA issued any draft guidelines regarding their intention to regulate autologous stem-cell therapies that take place in a doctor’s office?

CC: Not with regard to “the practice of medicine,” just with regard to drugs. The FDA website concerning this topic is “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” (see “Resources” below).

h+: Has your own organization American Stem Cell Therapy Association (ASCTA) issued similar guidelines?

CC: Yes, and they are even more specific to autologous stem-cell therapy than the FDA’s own guidelines, which derive from a 50-year tradition of drug regulation.

h+: Have you worked with animal models to provide the safety component of a pre-clinical trial?

CC: There are hundreds of animal model studies with mesenchymal stem cells. There is published research on rats, dogs, and pigs to demonstrate the safety of autologous mesenchymal stem cells infused into the lumbar spine, so we know that they are safe for these animals. Furthermore, veterinarians have been using these treatments for expensive racehorses afflicted with arthritis or inflamed ligaments to positive effect. Nevertheless, there is no substitute for human studies, as compared with animal models, for patient treatment. Each species presents unique problems in terms of calculating the dose of cells, route of administration, and establishing the optimal time for treatment-onset following trauma or a chronic condition.

Calculating the treatment regimen over several months is also species specific. We hope to establish our guidelines in collaboration with a community of stem-cell physicians who are working in this area.

Source: Dallas Observer

Not many people relish having to wear contacts or glasses, but for Adam Williamson, poor eyesight was more than a headache. The 25-year-old from Garland was paralyzed in a dirt bike accident three years ago, and his worsening vision made for yet another roadblock in his daily life. His morning routine — shifting into his wheelchair and rolling into a door-less, chair-friendly shower his parents set up on their patio — became even more challenging when his extreme far-sightedness made him dizzy upon waking and had him struggling to keep his balance. Then there was the soreness he began to experience as he studied for his Richland College finance classes or typed at the computer.

He tried glasses, but as a young man interested in enjoying more independence, not less, having to keep someone on hand to pick up his spectacles if they fell off or wipe them if they got smudged wasn’t exactly his first choice. He tried contact lenses, but “I just didn’t have the dexterity in my fingers to put them in,” he says. “It took three people and 15 minutes to get one contact in, and it was painful because they couldn’t tell how much pressure they could put on my eye.”

Williamson and his parents — who, since their son’s accident, have spent most of their free time caring for their son and used savings and retirement money to pay for experimental treatments in places as far away as China — have never been much for settling. So when Adam told his father, Phillip, that he was interested in Lasik surgery, they looked into it. Problem was, he was so far-sighted that Lasik wouldn’t work. Next, they talked to a doctor in Virginia Beach about something called a restoration lens, but it turned out those only worked for the near-sighted. “The doctor suggested something called the Crystalens,” Phillip said, “But he said it probably wouldn’t happen because it’s only for old people.”

In researching the Crystalens, a lens implant manufactured by Bausch & Lomb that emulates the human eye by moving back and forth to accommodate both short- and long-distance vision and is usually used for cataract surgery, the Williamsons found the Key Whitman Center on Lemmon Avenue. They met with Dr. Jeffrey Whitman, who said that while it was rare to do the implant on young people and even rarer on paralysis victims, he would do it. It would cost $11,000 though, and that was too much.

“I hope it’ll help my balance so I can get up in the morning and not have to worry about getting all light-headed,” Williamson said in the waiting room shortly before undergoing the procedure. “It’ll be easier to study, and, hopefully, I won’t get as sore from looking at the computer.”

Whitman said he did the first Crystalens surgeries on patients as young as 13 after the new lens was approved by the FDA in 2003, but this would be the first time he or any other surgeon he knew of had performed on a paralysis victim.

Williamson had the first eye done last week and already noticed a major improvement. “I could see really well far-off in the first few days, ” he says, “and it won’t even reach its full potential for another three months.”

Wednesday’s surgery wasn’t the first rare procedure he’s had done since his accident. His father, an auditor, and his mother, a retired teacher, sprung for trips to Arizona for an experimental magnetic therapy and to China for stem cell implants. They credit the treatments with major improvements in sensation and movement.

“After his physical therapy he could move only his wrists, and he had trouble sitting up because he couldn’t control his abs and back muscles,” says his father. Now he can sit up, as well as move his hands and upper arms. Williamson was only the 45th person in the world to have the type of stem cell treatment he got in China, and only the 20th to get the magnetic therapy, according to his father.

“I was willing to take the risk,” Williamson said, “I don’t have a problem going out of the box.”

After wheeling him into the operating room, Whitman removed his natural lens and replaced it with a crystal one. The whole procedure took 10 minutes.

We have the slide show here.