New Delhi: In a move that could spur a debate on science and ethics, the drug controller general of India (DGCI) has asked infertility expert Geeta Shroff to explain her claims of having successfully treated about 800 patients suffering from chronic spinal cord injuries and other ailments through human embryonic stem cell therapy.

“We have written to her asking for an explanation," said an official at the drug regulator’s office. “Since there are no guidelines for the use of embryonic cell lines, we have asked her the basis on which she is using them, her experience, details of her patients, their current status and coordinates."

Treatment record: Geeta Shroff claims to have successfully treated about 800 patients suffering from chronic spinal cord injuries and other ailments through human embryonic stem cell therapy. Ankit Agrawal/Mint

A notice is not an indictment. It seeks an explanation from an entity or individual for certain activities, typically within a time frame. Shroff has replied to the notice.

“All patients treated so far suffer from incurable/terminal disorders," said Shroff. She added that she follows all ethical guidelines laid down by the Indian Council of Medical Research (ICMR), and each case she takes up is reported to the body.

Shroff, who runs a clinic called Nu Tech Mediworld in New Delhi, has patented her therapy and treats a number of foreign patients. The hospital has the required certification for laboratory and clinical practices.

Embryonic stem cells, the use of which has been shown to lead to tumours, are derived from an early-stage embryo and their use in research and therapy has been controversial.

In an interview with Mint, Shroff said she uses cells derived from an embryo she received from a couple who took to in-vitro fertilization (IVF) almost 10 years ago.

“That is the only embryo I have used for all my work and it’s the only one I will ever need," she said.

Shroff, who claims to have cured type 2 diabetes through her therapy, said that she has treated 800 patients to date for various chronic terminal disorders.

Some Indian stem cell researchers have raised doubts on the work done by Shroff, who is yet to publish her findings in a peer-reviewed medical journal.

“The biggest question is whether she uses embryonic stem cells at all," said Satish Totey, chief executive of Ansa Research, a Bangalore-based research and development firm focusing on different areas of neuroscience and allied research. “As of date, the most renowned experts in this field have not been able to handle embryonic stem cells in therapy, more so because these cells have to be differentiated before use or can cause tumour."

But, according to Shroff, the cells she uses are early-stage cells, as compared with the ones being researched by others.

Totey was previously the head of Stempeutics, the stem cell research and therapy arm of Manipal Hospitals.

A few years ago, he was part of a team led by the ICMR which visited Shroff’s clinic and wanted to examine her laboratory, research and findings. They were not allowed to enter the laboratory since there were no guidelines pertaining to stem cells, Totey said.

“My lawyers told me not to show anyone my laboratory. I followed their advice," said Shroff, who did not allow Mint journalists to enter her lab either.

In January 2009, the US Food and Drug Administration approved the first-ever, phase-one clinical trials for transplantation of cells derived from human embryonic stem cells into patients suffering from spinal cord injuries. The study was conducted by Hans Keirstead and colleagues at the University of California at Irvine and supported by the Geron Corp.

Shroff’s claim to have treated 108 patients with chronic spinal cord injury in a presentation made in October at a conference in South Korea was brought to the health ministry’s notice by the science and technology ministry, according to a health ministry official. This was confirmed by another official at the science and technology ministry. Both declined to be named.

“These (embryonic) cell lines have to be well-characterized and backed by data on their safety aspect," the health ministry official said. “None of this was found in her presentation."

India has no laws governing the use of stem cells. Although the health ministry has approved and notified a committee to look at therapies related to stem cells and genes, it is not mandatory. A set of guidelines have also been issued by the drug regulator, but these pertain to stem cell banking and not therapy.

Shroff now intends to apply to the committee notified by the health ministry to gain approval for a clinical trial she is planning for her therapy in collaboration with a hospital. She declined to disclose the name of the hospital.

“We have recommended to the government that to avoid misuse of these cells, it should implement the same guidelines for stem cell therapy that it currently uses for injectables," said Totey.

A new vaccine has to be first clinically tested in human beings and proven for safety and efficacy, then approved by the DGCI before it can be administered to a subject.

Jacob P. Koshy contributed to this story.