Stempeutics Research has received funding to the tune of Rs.3.5 crore from the Department of Biotechnology (DBT) under Biotechnology Industry Partnership Programme (BIPP) to commence phase II clinical trial of its Investigational Medicinal Product ‘stempeucel’ in patients with alcoholic liver cirrhosis.
Earlier the company received Drug Controller General of India (DCGI) clearance for starting this trial and subsequently applied for DBT funding. This is the first time that the DBT has awarded a private organization for conduct of a stem cell clinical trial. Successful outcome of this clinical trial will have huge impact in India and worldwide. Product “stempeucel” is developed from allogeneic mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology.
Our team is working towards launching the first ‘off-the-shelf’ adult allogeneic stem cell product in the Indian market by the end of 2014. Stempeucel product has been developed based on international standards under stringent quality processes. In India we have pioneered large scale upscaling of mesenchymal stem cells and we expect that it will be the most cost effective product globally,” stated BN Manohar, CEO, Stempeutics Research.
Liver cirrhosis is a serious issue worldwide and difficult to treat. The condition presents a late stage of progressive hepatic fibrosis characterized by distortion of hepatic architecture and formation of regenerative nodules. It eventually leads to fatal decompensation and terminates as death. Alcoholic cirrhosis develops in 15 per cent of individuals who drink heavily for more than a decade. Prevalence of alcoholics in India is found to be 21 per cent in adult males. This ranges from as low as 7 per cent in western state of Gujarat to 75 per cent in north eastern part of India.
The standard treatment for advanced decompensated liver cirrhosis is orthotopic liver transplantation. However, potential benefits are hampered by many drawbacks such as relative shortage of donors, operative risk, post transplant rejection, recidivism of the pre-existing liver disease, high costs and several complications. More advanced treatment is the infusion of isolated hepatocytes which is constrained by the unavailability of liver and needs repeated transfusions. Bone marrow derived allogeneic mesenchymal stem cells may be helpful in these patients. The beneficial effect of stem cells is proposed to be multifactorial. Stem cells can transdifferentiate to hepatocytes like cells, can stimulate endogenous stem cells in the liver by paracrine action and may have fibrolytic effect leading to possible liver regeneration. Success of this project will make India to become one of the leading countries after USA to develop stem cell based drugs for unmet medical needs like liver cirrhosis.
The primary objective of this clinical trial is to assess the safety following a single administration of different doses of stempeucel administered via the percutaneous puncture of the femoral artery followed by selective cannulation of the hepatic artery (Seldinger Technique) in liver cirrhosis patients.
The secondary objective is to explore the efficacy by assessing the potential of allogeneic mesenchymal stem cells to improve the liver function and quality of life in liver cirrhosis patients. The aim is also to find the suitable dose of allogeneic mesenchymal stem cells to improve the liver function and quality of life in liver cirrhosis patients. Stempeutics Research Private Limited is part of the Manipal Education and Medical Group with facilities in Bangalore and Manipal (India) as well as in Kuala Lumpur (Malaysia). The company is in the process of bringing the first stem cell therapy product to the Indian market. It has completed pre clinical studies demonstrating the appropriate safety profile of human bone marrow-derived ex vivo cultured adult mesenchymal stem cells in allogenic settings. It obtained DCGI approval for conducting multi centric phase I/II combined double blind randomized allogenic clinical trials which is on-going for its two most advanced programs, indicated in acute myocardial infarction (AMI) and critical limb ischemia (CLI) making it the first allogenic stem cell clinical trial approved in India. A phase IIb/III study is planned to be conducted in India in 2010. Another phase III study will be planned outside India. This second phase III is likely to be supportive for the registration of the product in ASEAN countries.
In addition, several programmes are currently awaiting DCGI approval for various indications including chronic obstructive pulmonary disease, dilated cardiomyopathy, liver cirrhosis, osteoarthritis and diabetes mellitus. In Malaysia Stempeutics has obtained Ministry of Health approval for cerebral stroke clinical trials. Stempeutics long-term objective is to market its products in the European and North American markets.