The Canadian company Stem Cell Therapeutics (SCT) has received authorization from the Drug Controller General of India (DCGI) to begin enrollment in the Phase IIb clinical trial for the treatment of acute ischemic stroke with adult stem cells.
The double-blind, randomized, placebo-controlled clinical trial, which has a recruitment target of 128 to 130 patients, will utilize the modified REGENESIS proprietary protocol developed by SCT. Dr. Steven C. Cramer from UC-Irvine and Dr. Michael D. Hill of the University of Calgary are the two principle investigators of the study.
According to Dr. Alan Moore, president and CEO of SCT, "Approval from DCGI to initiate recruitment for the modified REGENESIS stroke trial in India is an exciting milestone for SCT. Jurisdictional approvals have now been granted in India, the U.S. and Canada, therefore we will begin recruiting patients as soon as possible."
In accordance with their regulations, the DCGI states that, "The DCGI approval process categorizes clinical trials into two types. If the study protocol has already been approved by a cognizant regulatory authority in one or more developed countries (such as the U.S., Canada, the U.K., Switzerland, Germany, Australia, Japan, and South Africa), the study is classified as a Type A trial and can be approved using a fast-track process within two to six weeks after the required documentation has been submitted. All other studies are classified as Type B. For these, the approval process is generally 8 to 12 weeks. The Institutional Review Board (IRB) approval process can be conducted in parallel with the DCGI review and, if import licenses are needed, the applications for these can also proceed in parallel. These provisions facilitate the process of getting study protocols in place and quickly initiating the trials." In other words, India is an excellent place in which to conduct clinical trials, since the approval process moves much more quickly than it does in many other countries. A number of businesses from the U.S., the U.K. and Europe are therefore turning to countries such as India for the testing and commercialization of their new medical products, whether related to stem cells or not.
In this particular case, the therapeutic product developed by SCT, known as REGENESIS, contains a proprietary combination of compounds which are designed to stimulate the body’s naturally occurring, endogenous adult stem cells for the healing and repair of damaged tissue. As described on the company’s website, "Stem Cell Therapeutics Corp. is a Canadian public biotechnology company focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient’s own resident stem cells. The Company’s programs aim to repair brain and nerve function lost due to disease or injury. The Company’s extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases such as traumatic brain injury, multiple sclerosis, Huntington’s disease, Alzheimer’s disease, and ALS."