
Stem cell research in the country will reach a new milestone with clinical trials on humans all set to start in February next year. Stempeutics, a stem cell company focused on research and development of human stem cell technology in the field of regenerative medicine, will conduct trials in the areas of myocardial infarction, spinal cord injury and limb ischemia.
"We have finished a pilot study in these areas and have found the results to be very good. We will start the Stage I and II of Human trials on February 1 next year," said Dr Satish Totey, chief scientific officer, Stempeutics.
The one-year-old company is accredited by the Indian Council of Medical Research (ICMR) and has its facilities based at Manipal Hospital. The trials will take place in five hospitals across the country and will be completed in one year.
"We are following the US Food and Drug Administration (USFDA) guidelines for the pre-clinical studies which will take place on animals before the human trials begin in February. We will treat 120 patients each for spinal cord injury, myocardial infarction and limb ischemia (peripheral vascular disease),'' said Dr Totey.
"We will submit our data to the Indian Council of Medical Research and Drugs Controller General of India (DGCI) after the trails in Stage I and II.
Though not required in India, we are ready to conduct Phase III trails if they ask us to. Once the drugs are ready, we wish to provide them in an injectable form at a very affordable price," he added.
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