Ashley Thomson says he feels “human again.” He spends a few hours every day now standing upright and walking, with the aid of stiff, metal leg braces. After nearly a decade in a wheelchair, it is a revelation. “It feels cool to look people in the eye. It was time for me to get up.”
Mr. Thomson, 28, got up on his feet last fall, after just two weeks of treatment at a New Delhi clinic where he received injections of what his doctor says is a solution of human embryonic stem cells, which was also used to “irrigate” the spinal cord he broke in an accident almost 10 years ago.
After five weeks, Mr. Thomson says, he could move toes that had been immobilized, had sensation in his quadriceps and could sense the texture of different materials – such as sheepskin from his native New Zealand – under his back. By the time he left Delhi two months later, he had shooting sensations all along his once-deadened leg.
The apparently life-changing therapy he was receiving is untested, unproven, unmonitored and highly controversial. With his trip to Nu Tech MediWorld in the Indian capital, Mr. Thomson became one of thousands of desperate foreigners, including dozens of Canadians, who've flocked to Indian stem-cell centres, seeking therapies prohibited in their own countries. With legislation held up indefinitely in its parliament, India has in effect no restriction on what clinics such as Nu Tech can promise.
Mr. Thomson, who fundraised for seven months to acquire the $50,000 (U.S.) for his first three-month course of treatment, isn't interested in the doubters. His doctor, Geeta Shroff, is equally serene. A former infertility specialist, she says she has cultured an endless line of stem cells from a single embryo donated by a fertility patient a decade ago.
She says she is the first person in the world to do this, and that her treatments are effective because they use pure embryonic, not adult, stem cells and no other species' genetic material. She says she has treated 700 patients and all have shown improvement with no side effects.
Dr. Shroff does not share data, has not submitted to peer review (she's said she has “no peers”) and has performed no controlled clinical trials. While patients call her a saviour, other researchers call her a quack, a fraud or names even less flattering. In her gleaming private hospital in a posh Delhi neighbourhood, teeming with patients paying thousands of dollars for her therapy, she shrugs off the skeptics.
Dr. Shroff is one player in the rapidly expanding world of stem-cell treatment, much of which takes advantage of regulatory gaps in countries such as China and Mexico to offer untested treatments. Research from the Health Law Institute at the University of Alberta in 2008 found 29 centres around the world using the Internet to market stem-cell therapy, at an average cost of $21,500 (Can.) per patient.
But what is striking about India is that the regulatory gap (which appears to reflect a mix of ignorance and inefficiency on the part of government) means that practitioners such as Dr. Shroff who work on the fringes are infuriating a community of researchers, many based in some of the country's top scientific institutes. These researchers follow a more familiar and respected scientific route – although they, too, are doing work with stem cells that would not be permitted under the laws of Canada or the United States.
“The government needs to look at the practice of stem-cell therapy more seriously. The regulators … do not seem to realize the potential and problems associated with this therapy,” says Maneesha Inamdar, associate professor of molecular biology and genetics at the Jawaharlal Nehru Centre for Advanced Scientific Research in Bangalore. She adds that “while one cannot simply dismiss the claims of success in unregulated therapies,” given the quantity of positive stories such as Mr. Thomson's, the lack of data “puts the field at a disadvantage and under suspicion.”
In 2007, the Indian Council of Medical Research (ICMR) adopted guidelines that state that “there is no approved indication for stem-cell therapy as a part of routine medical practice, other than bone marrow transplantation.” All other therapies were ruled experimental. But the guidelines are non-enforceable, and although there has been a draft law that would bring India largely in line with international standards before its parliament for several years, it has made no visible progress toward becoming law.