About 50.8 million Indians are already affected by diabetes. And with each passing day, the figure is expected to go up. At least 8% of the population in towns and about 12% in metropolitan cities above 25 years of age suffer from this ailment. However, thanks to stem cells, there is a permanent cure at sight.
Stempeutics Research has got clearance from the Drug Controller General of India (DCGI) for the company's investigational medicinal product Stempeucel for conducting phase II clinical trials on patients with diabetes. The good news is that the organisation has short-listed Kasturba Medical College and Hospital at Manipal to be one of the centres for this clinical trial. “This institute has got separate diabetes cell. Also, the doctors there are keen on working in this research. Moreover, the manufacturing unit of Stempeutics is set up at Manipal. So we decided to involve Kasturba Medical Hospital,” said BN Manohar, chief executive officer, Stempeutics.
The institute is yet to identify two more hospitals for the clinical trials. “As of now, we have been given permission to run clinical trials on type 2 diabetes. The trial will be done on 30 patients and it will be a double blind study, following the international standards,” he said.
According to the procedure, 10 patients will get one particular dosage of stempeucels, another 10 will get a higher dosage and the remaining 10 will get placebo (no drugs). “It will take at least 12 to 14 months to complete the study,” said Manohar.
Stem cell therapy can prove to be a breakthrough in curing diabetes, said Dr Majumdar.
“Diabetes are of two types. In type 1 diabetes, the betaislet cells in the pancrease responsible to produce insulin gets degenerated due to an auto immune disease. In type 2 diabetes, body cells are unable to utilise insulin. In an advanced type 2, degeneration of betaislet cells too happen,” he said.
With the help of stem cell therapy, regeneration of betaislet cells in the pancrease can be achieved. Also, stempeucels have a property of immuno suppressants that will prevent betaislet cells from degeneration, said Dr Majumdar.
While the clinical trial will mostly start off from April, the product is expected to hit by the end of 2016.
