CryoStemcells (Karnataka) Pvt Ltd. has decided to extend its clinical trials to save patients suffering from Ischemia and Buergers's disease. The company has been conducting maximum number of trials for treating the two diseases with stem cells during last three years and has been submitting the required efficacy and safety data to the Drugs Controller General of India and Indian Council of Medical Research. But despite several requests both DCGI and ICMR have not cared to grant permission for the treatments.
Ample proof on the success of stem cells to treat chronic critical limb Ischemia, Buergers's disease, liver cirrhosis and spinal chord injuries by CryoStemcells has been totally ignored DCGI and ICMR. Instead of waiting indefinitely, the company has thus gone ahead to carry out treatment adhering to stringent clinical trial protocols.
Although there is no dedicated regulatory authority in place to grant permission and the onus of the approval rests with DCGI and ICMR, there has been no delay in issuing notices to stop use of stem cells for treatment. Warnings in the absence of a law makes no sense. "In order to keep the warnings at bay and to offer the much-needed relief to patients, we are conducting more trials. Every patient condition is recorded via MRI imaging prior to stem cell infusion and post recovery," Dr SGA Rao, chairman and managing director, CryoStemcell (Karnataka) told Pharmabiz.
"We are confident about the efficacy of stem cells to treat these conditions. But the issue is approval for treatment. ICMR and the DCGI should make up their minds about providing consent for stem cells treatment without unnecessary delays," he added.
The company has a set up a stem cell wing at the St Theresa Hospital, Jain Institute of Vascular Studies (JIVAS), part of the Bhagwan Mahaveer Jain Hospital and the SRB Jain Stem Cell Research Centre.
The limb ischemia and Buergers' disease trial under the supervision of Dr KR Suresh, head JIVAS is reported to have a huge patient pool sign up for the study.
The Ethics Committee's consent has come in to start the Duchenne Muscular Dystrophy (DMD) trial for the paediatric patients at the St. Theresa Hospital in association with National Institute of Mental Health and Neuro Sciences (NIMHANS). The Parkinson's disease trial will be held at Yeshoda Hospital, Hyderabad.
CryoStemcell has inked pacts with individual specialists and hospitals for clinical trials. These include osteoarthritis trial at Mumbai using bone marrow and lipo aspirated Mesenchymal stem cells. In association with KEM and Dr Nair's Hospital, Mumbai, it is adopting a new minimal invasive method to implant stem cells via the third vertebrae which are under clearance by the Ethics Committee.