From BioHealth Investor
by H.S. Ayoub
BioHealth Investor.com
The FDA issued a warning letter to Dr.Alfred T Sapse of Stem Cell Pharma, Inc.,a Las Vegas company, alleging that the doctor and the company had violated federal law by injecting placental stem cells into patients without prior approval.
According to the letter Dr.Sapse overlooked the injection of stem cells into at least 16 patients in an attempt to treat Multiple Sclerosis, Muscular Dystrophy, and other disease conditions. The doctor however claims that more than 40 patients have so far undergone the procedure.
He also failed to carry out proper testing, handling, and processing of the placental tissue used to harvest the stem cells. He worked with a local hospital to obtain the placental tissue, and a local surgeon to carry out the injections. He refuses to identify the parties.
The doctor also allegedly refused to allow an investigator with the FDA to inspect patient records of the procedures back in July of 2006.
Charging as much as $5000 per procedure, the Romanian opthalmologist claims on the company’s website that the injections have shown a 70 percent imporvement in the patients’ conditions.
The company also provides a service for patients looking for stem cell transplants outside the U.S.
Here is a list of the various costs of the procedure:
Dominican Republic $30,000
Tijuana (Mexico) $20,000
San Jose (Costa Rica) $25,000
Bankock (Thailand) $30,000
Habana (Cuba) $20,000
Russia/China $20,000
Seoul (S. Korea) $90,000
Germany $250,000+.
The company also claims that Americans have already spent about $150 million to receive the procedure in various foreign nations, and that amount will increase to $1 billion over the next 5 years as patients become more aware of these clinics.
In an exclusive interview with ABC 13 Action News, Dr.Sapse claims that the patients were all dying with little hope of recovery. After the FDA! warning , and it is only a warning, the doctor has halted all work and will submit all paper work for review.
All the patients that were hoping to receive the injections soon, will now not be able to.
It may take several years before any stem cell transplantation becomes legal in the U.S., accodring to Dr.Sapse.
Shares of stem cell companies, Geron (GERN), StemCells (STEM), Aastrom (ASTM), ViaCell (VIAC), and Thermogenesis (KOOL) were all mixed with little movement on Friday.
http://www.biohealthinvestor.com/
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