Stem cell scientist Satish Totey almost dreads answering his phone these days. He’s lost count of the number of calls he’s had to field in recent months from desperate relatives, friends, even distant contacts. They all call to ask whether he might be able to help cure a dreaded disease: diabetes, liver failure, end-stage kidney disease, paralysis, cancer or Parkinson’s.

Each time Totey, director of the stem cell research clinic at the Manipal Hospital in Bangalore, struggles to explain that while stem cells still hold enormous promise for medicine, for the moment, hype appears to have overtaken the science.

But Totey is now expecting more such calls. Last week, a fertility specialist in New Delhi took recourse to what sections of the scientific community view as the maverick stunt of calling a media conference to claim that she had used stem cells from human embryos to treat a variety of diseases and injuries in 100 patients.

Nowhere in the world have human embryonic stem cells been used to treat patients because, scientists say, the technology is not mature enough for human applications. International researchers are equally worried about the developments in India. “Despite the huge effort towards the use of embryonic stem cells, progress has been slow because there is a danger of tumour formation,” warns Dov Zipori at the department of molecular biology at the Weizzman Institute of Science in Israel.

At Wednesday’s press conference, Geeta Shroff, director of Nu Tech Mediworld, a registered genetic centre that started as an infertility clinic, displayed ‘Before and After’ video clips of some patients in whom she had injected embryonic stem cells. She released some information about each of her patients. Among them was former Chhattisgarh chief minister Ajit Jogi, paralysed after a car crash.

And there was a 37-year- old woman who suffered spinal injury and brain damage after a road accident, 17 years ago, that had left her with facial paralysis and an inability to talk. After the treatment, or so claims Shroff, the woman can talk and her facial paralysis is gone.

But it is not just an issue of claims and counter-claims. An independent neurologist from a local hospital states that some of her patients with spinal injury have indeed shown an improvement.

What’s at stake here is the likely impact of unfettered research. The episode has given rise to concerns that the existing guidelines that govern medical research in India leave doctors virtually free to do what they wish with scant regard for established scientific principles and medical ethics.

Shroff’s assertions have evoked sharp reactions from senior government officials and scientists who stress that she has not provided a shred of evidence that would withstand rigorous scientific scrutiny. Testimonials by patients do not constitute scientific proof that therapy works, they say. Patients can respond to treatment through what is known as a placebo effect and can occasionally get better. “The right way to determine whether therapy is effective is to design a detailed scientific study,” says Samiran Nundy, a senior gastrointestinal surgeon at the Sir Ganga Ram Hospital in New Delhi and an expert on medical ethics.

'We will not work with any group without Good Manufacturing Practices in stem cell production' Maharaj Bhan - Secretary, Dept of Biotechnology

The appropriate route to announce major scientific advances is by getting research accepted by the peer community instead of rushing to the media. But Shroff has neither published her work in a peer-reviewed journal nor provided details of her techniques to other researchers in the field. Top officials of the Indian Council of Medical Research say they have no idea what she is doing.

It’s not just the actions of a private doctor that are under question. For several months now, medical experts in India and abroad have been puzzled by a series of studies by doctors at the All India Institute of Medical Sciences (AIIMS) in New Delhi.

There, a team of doctors led by director P. Venugopal has used stem cells to treat patients with heart disease and currently incurable brain disorders such as muscular dystrophy and cerebral palsy. The AIIMS doctors have used stem cells derived from the bone marrow of the patients themselves. While AIIMS has reported promising results, scientists have questioned the design of the study.

When Venugopal presented his preliminary results at a conference in Mumbai in September this year, delegates pointed out that the exact identity of the stem cells that the AIIMS doctors were injecting into their patients was not clear. Also, “the way the study is designed, it’s hard to attribute the results to the effect of the cells,” says Mahendra Rao, a stem cell researcher at the US National Institutes of Health in Bethesda.

There are signals that the government is waking up. Earlier this month, the Department of Biotechnology (DBT) pledged tighter controls on stem cell research. “The DBT or the ICMR will only be able to control research groups whom we fund,” says biotechnology secretary Maharaj Bhan. “We can’t control those who don’t come to us,” he holds. For that, India’s drug regulatory agency would need to issue notifications that would make it mandatory for all researchers in the country to follow prescribed guidelines for research on stem cells.

Government officials concede that it is too early to say when new rules might come into force and how they will be implemented. And even within the government, some lack of harmony is evident. Eyebrows shot up in some research policy circles when health secretary Prasanna Hota turned up as chief guest at Shroff’s media conference where she announced her claims of treating 100 patients on Tuesday.

'I’ve only treated patients with incurable conditions, patients for whom medicine offers no hope' Geeta Shroff - Director, Nu Tech Mediworld

“She’s a daring soul who’s dedicated herself to this work without any government patronage,” Hota said, adding that this was an area where support would need to be organised. However, moments later, in what might have been a corrective mode, the health secretary made it clear that the government would work to see that “only good work proceeds and that quackery is not allowed”.

The studies by Shroff and by the AIIMS doctors have worried some scientists about their possible effect on future stem cell work in India. “My biggest fear is a regulatory backlash,” says Totey. Screening panels would look at all research proposals with suspicion, he fears.

Despite the controversies, the government appears keen on promoting stem cell research. Last month, the DBT announced a Rs 25 crore programme to support research in several top medical institutions to explore the use of stem cells in the treatment of heart attacks and strokes.

Only laboratories that follow “good manufacturing practices” or GMP can serve as a source of stem cells that need to be manipulated in the laboratory for further growth. “We will not work with any group without GMP in stem cell production,” Bhan maintains.

The DBT is also establishing a three-approval system to evaluate the science and ethics of specific research projects that would involve the use of stem cells in human patients. Every project would need to be approved by all three committees.

But legal experts say that it’s important to plug the legal vacuum in which stem cell research operates today. The existing guidelines are not enforceable on organisations that do not seek government funding.

Says Sainton Basu, a lawyer in the Supreme Court who specialises in corporate law and regulatory issues in biotechnology: “Guidelines are at best good practice and, at worst, just scraps of paper.”

Shroff, at the centre of the current storm, asserts that she has broken no law. She presented her findings at the American Society of Gene Therapy at St Louis in the US earlier this year. “I’ve only treated patients with incurable conditions, patients who’ve lost all hope, for whom medicine offers no hope,” says Shroff. “When I saw the fascinating results, I thought I’d share what I’ve found. That’s all.”

The debate is set to intensify in the coming months, as more researchers take the plunge into stem cell research. Public expectations are going to mount as well, as an increasing number of people pin their hopes on the promises of these wonder cells.

Totey’s phone isn’t going to stop ringing any time soon.

The promise of miracle cells

HARVESTING EMBRYONIC STEM CELLS

Stem cells are special cells that lack identity, but have a capacity to turn into any of the specialised cells in the body. An identity-less stem cell is said to ‘differentiate’ into a specific cell type such as a heart cell, a brain cell, a liver cell or a blood cell.

Scientists have been able to isolate stem cells from embryos, foetuses and adult bone marrow. The medical interest in stem cells springs from their potential to differentiate and give rise to brand new specialised cells that might be used to replace diseased or damaged tissues and organs in the body.

Researchers are hoping that one day the ability of stem cells to generate new cells will allow doctors to treat a number of what are currently incurable conditions including degenerative brain diseases.

But doctors warn that all uses of stem cells today — except in leukemia, lymphoma and inherited blood disorders — are experimental.

Stem cells extracted from the bone marrow have been used in the treatment of cancers. The bone marrow harbours a set of stem cells that can give rise to other blood cells. In cancer therapy, doctors take out the marrow, allow the stem cells to multiply, and reinfuse them back into patients. However, the use of bone marrow stem cells for other conditions such as spinal cord injuries or heart disease is still at an experimental stage. Human embryonic stem cells are even more difficult to work with. Embryonic stem cells are harvested from the inner cell mass, a cluster of cells obtained from the blastocyst, a tiny four-five day old embryo. Scientists worldwide are scrambling to tame embryonic stem cells. The biggest challenge is to get a 100 per cent pure population of the required specialised cells from the embryonic stem cells. No one has succeeded in achieving that yet.