Human Clinical Trials for Stem Cell Research on Cards

In what is seen as a boost to the stem cell research in the country, India would soon get to host human clinical trials for therapies using umbilical blood cord (UBC) stem cell.

Chennai-based Apollo Hospital, America’s largest stem cell company StemCyte and Dr Wise Young, a leading expert on spinal cord injury, are in talks for conducting clinical trials in India using stem cell derived from UBC. The companies may ink an agreement by the end of this year.

On Thursday, StemCyte announced setting up of StemCyte India Therapeutics (SCITPL), a joint venture with Ahmedabad-based pharma major Cadila Pharmaceuticals and Apollo Hospital. SCITPL will have its headquarters in Ahmedabad and the facility will be functional by the year-end.

Clinical trials using UBC stemcell therapy would be carried out in three areas — thalessemia, muscular dystrophy and spinal cord injuries. Initially, the phase III trials would start for therapies to treat spinal cord injuries. The phase I & II trials have already been conducted in the US and China.

While Bangalore-based Stempeutics Research recently got the clearance from the Drug Controller General of India (DCGI) to conduct trials for developing drugs using stem cells derived from the bone marrow of healthy donor, the latest move by StemCyte involves the use of UBC stem cell.

Talking to ET, Dr Wise Young who is professor in Rutgers, the State University of New Jersey, said: “We had initial talks to conduct clinical trials using stem-cells derived from UBC in India. Hopefully, by the end of next year, we should begin our clinical trials here.”

According to StemCyte India Therapeutics president Tushar Dalal, the three parties met in New Delhi on Wednesday and had a video conference with Apollo chairman Pratap Reddy. “Dr Reddy has expressed his willingness and would come forward to undertake this project. StemCyte would provide UBC stem cells and its technology, while Apollo Hospital would provide its infrastructure and manpower for the trials,” Mr Dalal said. A tripartite agreement is likely by this year-end, he said. Dr Young would head the trials.

StemCyte has patented the plasma depletion technology that helps in collecting higher volume of stem cells and better cell counts, resulting in successful therapeutic applications for over 70 diseases. The location of the trials is significant, as India has a huge number of thalessemia patients. According to Dr Young, about 35% of the Indian population carries thalessemia genes and there is possibility of one-fourth of the children being born with the disease.

Posted on August 10th, 2009 in Clinical Trials and Studies. Tagged: