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For stem cell therapy, patients call Tampa

By KRIS HUNDLEY
Published January 5, 2007

After New York City chiropractor Rich James had a stroke in February, he kept reading accounts of people with stroke-related paralysis being treated with stem cells at clinics outside the United States.

But every time he tried to locate such a clinic, the 52-year-old, whose left side was paralyzed by the stroke, hit a brick wall. Or he ran into people who were willing to take his money but didn't even have a Web site.

Through an online stroke support group, James heard about Stem Cell Therapy International Inc. in Tampa, which has arranged treatment for 15 patients, most with strokes or multiple sclerosis, in offshore facilities. In July, James paid SCTI $30,000 for five days of treatment in a clinic in Kiev, Ukraine, where he received infusions of stem cells from umbilical cord blood.

While James' left arm and leg are still not fully functional, he's gotten rid of his wheelchair and can walk short distances unassisted. He credits the stem cell transplants - plus ongoing physical therapy - with his recovery thus far.

"Just as important as what it did for me physiologically is what it did for me emotionally," James said. "Prior to the stem cell therapy, I had low-level depression and high-level anxiety, but now that's gone. It was a complete emotional turning point."

The cord-blood therapy James received has not been approved in the United States because scientists here say there is no clinical proof it works. And research using embryonic stem cells has been stymied by the Bush administration, although there are expectations such restrictions may be lifted by a Democratic Congress.

But U.S. policies toward stem cells have not been an obstacle for SCTI, which has attracted customers from inside and outside the United States. The company, headed by chairman and chief executive Calvin Cao, has affiliated itself with five stem cell clinics worldwide. In addition to Kiev, it sends patients to clinics in Tijuana, Mexico, as well as in Shenzhen, Shanghai and Beijing, China.

SCTI's Web site suggests stem cell treatments can be effective for everything from diabetes to menopause to muscular dystrophy. But there are skeptics. Dr. Michael Williams, a neurologist who is co-chair of the ethics committee at Johns Hopkins University in Baltimore, said SCTI's claims that stem cells can be used for such a wide range of maladies raise questions.

"It's hard to imagine a single therapy can cure all of that," he said in a recent interview. "And there's no proof it works."

In the United States, stem cells from cord blood are only used to treat such diseases as leukemia and genetic and immune deficiencies. The Food and Drug Administration considers the kinds of treatments arranged by SCTI to be experimental. Only a few such studies are under way in the states and these are being performed under highly monitored, clinical trial situations. That has driven patients like James to turn to SCTI and a handful of competitors that direct them to overseas clinics. The FDA has not commented publicly on SCTI's operations.

SCTI was created in September 2005 from a public shell company incorporated in Nevada. It currently trades over the counter on the Pink Sheets.

While Cao (pronounced "cow") said the company owns 26 stem-cell related patents that it hopes to license, patient-referral work accounted for nearly all the company's $500,000 in revenue in 2006.

"We have to focus on making money first," said Cao, who expects SCTI to become profitable in 2007. He said the company will arrange offshore treatments for about 100 patients this year.

Though they promote a controversial medical treatment, neither Cao, 40, nor Peter Sidorenko, SCTI's chief operating officer, has a medical background. Cao, a graduate of the University of South Florida in electrical engineering, has owned two technology companies. Sidorenko, 51, worked for IBM, AT&T and WorldCom. The tech bust in 2001 took a toll on both men, they said. Each filed personal bankruptcies during the past two years.

As they build SCTI, which has four full-time employees, Cao and Sidorenko are relying heavily on outside scientific advisers. These include the head of a stroke center in Jacksonville, a heart surgeon from New York City and a cryobiologist at Burnham Institute of Medical Research in La Jolla, Calif.

Treatment candidates have their medical records reviewed by these specialists, who receive stock in the company in exchange for their services. Cao said the advisers reject twice as many patients as they accept for treatment.

Sidorenko said the company makes no guarantees about the treatment's efficacy. But he is such a believer in the procedure's safety that he underwent stem cell transfusions in Kiev in September - even though he had no medical need for it.

"It makes my job easier," he said.

Rich James, whose blog chronicling his progress is featured on SCTI's Web site, figured he had no choice.

"I think when the treatment becomes available in this country, it will cost three times what I paid for it," he said. "And the insurance companies won't want to pay for it."

Times researcher Angie Holan contributed to this report. Kris Hundley can be reached at hundley@sptimes.com or (727)892-2996.

Who else is getting involved?

UTEK Corp. of Tampa is also getting involved in stem cells, but through an alliance with NeoStem Inc., a provider of adult stem cell collection, processing and storage services. This week NeoStem, based in New York City, opened its first center near San Diego where patients can donate and store stem cells taken from their blood. UTEK is working with NeoStem to identify technologies it might acquire.

Stem cells and stem cell therapy

What are stem cells? Stem cells have the potential to develop into many different cell types in the body. Serving as a sort of repair system, they can theoretically divide without limit to replenish other cells as long as the person lives.

Where do stem cells come from? Embryonic stem cells come from human embryos. Stem cells are also found in umbilical cord blood, bone marrow and several organs and tissues.

What are stem cells used for in the United States? Stem cells from cord blood are used to treat patients with leukemia, other cancers and genetic diseases. The use of cord blood stem cells to treat nonblood disorders, such as stroke or multiple sclerosis, is considered experimental and only being conducted on a limited, clinical trial basis.

Source: National Institutes ofHealth

[Last modified January 4, 2007, 23:10:24]