Inspections, Compliance, Enforcement, and Criminal Investigations
July 15 2010: Fraud Charges Filed Against Man for Causing Chronically Ill Persons to Undergo Experimental Stem Cell Implant Treatment
Alfred T. Sapse, 84, of
According to the Indictment, from about January 2005 to the present, Sapse allegedly devised a scheme to defraud patients and investors by claiming to have developed a novel medical procedure involving “stem cells” that would cure or improve certain severe, incurable diseases, such as multiple sclerosis and cerebral palsy. Sapse purports to be a retired foreign physician, but Sapse has never been licensed by the State of
The Indictment alleges that Sapse caused the implantation of portions of the placental tissue into the abdomen of sick patients for the treatment of their diseases. In about the fall of 2005, Sapse hired a local
Sapse allegedly failed to obtain any approvals from the FDA, as he knew he was required to do, prior to coordinating the implantation of patients with placental cells. In July 2006, Sapse made false representations, and instructed others to make false representations, to regulatory investigators with the FDA regarding his role in and the scope of his scheme.
In about February 2007, Sapse relocated his fraudulent scheme to
The Indictment also alleges that Sapse falsely claimed to patients and investors that he studied at the Filatov Institute of Eye Diseases and Tissue Therapy, a prestigious clinic in Odessa, Ukraine, where he purportedly learned about and performed placental implants; that the placental tissue he caused to be implanted in patients was obtained only from Caesarian section births, so as to reduce the risk of passing infection, or otherwise to prevent “damage” to the placenta; that he had achieved “considerable success” with a procedure that was going to “revolutionize medicine as it is known today”; that wheelchair bound patients would “definitely walk again”; and that he subjected the placental tissue he obtained to a “proprietary process,” such that the stem cells in that tissue would express a special enzyme that would cause the stem cells to replicate indefinitely. Sapse also conducted no follow-up with his patients after inducing them to undergo his implant procedure and collected no data, despite creating the impression that he was engaged in legitimate medical research. Sapse also concealed from prospective patients and investors the adverse effects suffered by previous patients, including infection and worsening of their symptoms.
Sapse allegedly received approximately $1 million from patients and investors, approximately $700,000 of which he spent on personal expenditures and for gambling at local casinos. Sapse did not use any of the money for laboratory research, animal studies or human clinical studies relating to the short- and long-term effects of the implant procedure he was promoting.
This case is being investigated by the FDA Office of Criminal Investigations and prosecuted by Assistant U.S. Attorneys Crane M. Pomerantz and Patrick M. Walsh.
The public is reminded that an indictment contains only charges and is not evidence of guilt. The defendant is presumed innocent and entitled to a fair trial at which the government has the burden of proving guilt beyond a reasonable doubt.