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.
Meanwhile, India has a booming medical tourism industry; many researchers here say the push for greater regulation pits them squarely against people in government who view the experimental therapeutic centres as potential revenue sources. The Stem Cell Research Forum of India predicted recently that the country's stem-cell industry – including research and therapies – will grow at 15 per cent a year; it netted $540-million (U.S.) last year.
At the very least, there is ambivalence in the government about how to handle businesses such as Dr. Shroff's. In 2005, Health Secretary Prasanna Hota was chief guest at a news conference Dr. Shroff held to talk about her treatment breakthroughs. In newspaper accounts at the time, Mr. Hota said his presence should not be construed as an endorsement of her work. He nevertheless went on to say that "sometimes, scientific knowledge cannot wait for bureaucratic apparatus."
METAMORPHIC MAGIC
Stem cells are unique among human cells for their ability to differentiate – to grow into different kinds of tissue. Clinics treat patients with cells that are derived from embryos, fetuses, umbilical-cord blood and adults; the cells may be from someone else, or autologous (one's own cells, derived from bone marrow).
Embryonic stem cells are prized for their plasticity, or ability to grow into any kind of tissue, but their use is particularly controversial because a human embryo must be created to obtain the cells. This led the Bush administration in the U.S. to ban federal funding for such research. But the ethical debate has not had many takers in India.
Dr. Shroff says she draws on qualities inherent to embryonic stem cells to do safe, effective therapy – that their growth and division slows down over time, as it would in a fetus, so that there is no risk of tumours; that they have no antigenic proteins and thus do not provoke immune reactions and match any blood type; that they can "home in" on damaged areas and make repairs.
She also says she has used them successfully to treat everything from Parkinson's and Alzheimer's to autism and Down syndrome; that she verifies results with tests such as CT scans at third-party facilities; and that she keeps video records of all patient progress.
Dr. Shroff says she began her research in a lab in her garage in the late 1990s and spent two years developing her process for establishing an infinite cell line. Then, she says, she "fully tested" them for safety, before in 2002 beginning to inject them into people. (She does not elaborate on how those safety trials were performed, except to confirm that it was not in the standard clinical-trial format.)
Her first patient was Indian and was suffering from a neurodegenerative disease with just months to live. Dr. Shoroff argues that India's current guidelines allow her to use any experimental therapy in patients who have terminal and/or incurable conditions. She does not do diagnosis herself and has what she describes as an ethics committee screen all patients.
Coverage in India's media, she says, attracted a few foreigners, who have used the power of the Internet to spread word about what she can do: "It's a totally human product. That's where I think I've scored."
She says she now can produce her stem-cell solution as a pharmacy-ready product that has a shelf life of six months and should, she feels, be used as the first line of treatment for spinal-cord injuries or degenerative diseases. She says she has applied for both Indian and international patents on it.
Cloak of secrecy
Her peers don't buy it. "It's so difficult to culture stem cells – how is she culturing such a large quantity and what kind of media is she using? Nobody knows," says Satish Totey, secretary of the Stem Cell Research Forum of India. Dr. Totey founded a Bangalore-based firm called Stemceutics, which is testing the use of adult stem cells to treat lung injuries, liver injuries and heart attacks. His are three-stage clinical trials; all results undergo scrutiny by the Indian Council of Medical Research as well as third-party validation.
Some of the greatest minds in science have tried and failed to culture stem cells, he says, while Dr. Shroff and a handful of others won't reveal the processes they used to perform this holy grail of research.
"Unfortunately in India the guidelines are all draft… so everyone is taking advantage of this and of desperate and vulnerable people. When it becomes law, the work of people like Geeta Shroff – I consider it like quackery – will be stopped."
Meanwhile Dr. Totey despairs that legitimate research such as his own is being undermined, but also worries for patients such as Mr. Thomson.
"People are at major risk. We don't know what is going to happen."
There isn't a vast field of data supporting the idea that stem-cell therapy is dangerous. One Israeli child developed benign brain and spinal-cord tumours after receiving unregulated transplants of human fetal stem cells in a Russian clinic; a genetic analysis showed that the tumours were derived from transplanted cells. The specific fear with embryonic stem cells is their propensity to form a tumour called a teratoma, which is normally benign but can be cancerous. Stem-cell therapies tested in rats have caused a variety of cancers.
Dr. Shroff dismisses these possibilities: Teratomas or other such side effects are not possible from her treatment "because of the technology" she uses, she says. Her clinic, she insists, has been endorsed by the International Organization for Standardization and deemed to follow good manufacturing, laboratory and clinical practices – in each case meeting standards designed to allow for acceptance of research in different countries. Dr. Totey, however, says he was at her hospital as part of a government investigative team and saw no such certificates before being asked to leave.
Prickling with a fixed-smile defensiveness, Dr. Shroff says she is a "law-abiding citizen" and "will comply" with any law that is passed.
In the meantime, says Timothy Caulfield, research director of the Health Law Institute at the University of Alberta, there is one thing Dr. Shroff could do to end the controversy.
"If people are getting better, people are experiencing improvements – let's see the data," he explains. "The world's greatest minds have studied this; their career is dedicated to this in hope of achieving what she claims she can do already. If, in fact, it works and she hasn't published data on it, that's not very ethical.
"Share your discovery with the world and peers can critique it and improve your technique. If she's so altruistic, let's see the data."
Grateful but puzzled
Inga MacVicar, a 60-year-old bookkeeper from Langley, B.C., has been to Nu World three times, seeking treatment for spinal injuries, including damage sustained in a 20-foot fall from a barn roof. Once, she says, she had back spasms so severe that they left her unable to breathe.
Today she swims 20 laps each day, an improvement she credits to her $60,000 worth of therapy in Delhi. "I saw a lot of miracles there, I really did," she says. "There were people moving who were told they would never have movement."
But Ms. MacVicar says she can't understand why Dr. Shroff, whom she believes kept her out of a wheelchair, is not more transparent. "It doesn't make sense. I don't know why she doesn't. If it works – and I know it does – then put it out there and help people."
Dr. Shroff says she is compiling data for publication, after patents are issued to protect her work from theft, and until then the best validation of her treatment comes from the patients who return repeatedly to undergo it. Mr. Thomson plans to return to Delhi next month; Ms. MacVicar hopes to raise the money to return this year too.
However, there is nothing in peer-reviewed medical literature to support successful treatment with embryonic cells for any condition Dr. Shroff claims to treat. Researchers such as Dr. Totey and Prof. Caulfield speculate that some combination of the placebo effect, cognitive dissonance (based on the very high price tag) and an immune response to the foreign fluid she injects may give patients the sense their bodies are responding to treatment.
Dr. Shroff contends that the criticism she draws is nothing more than sour grapes – and many patients seem to agree.
"I think she's an amazing, smart woman and I think personally all the other doctors who are giving that criticism are jealous," says Mr. Thomson. "They're annoyed that she's beaten them to it."