India’s First Allogeneic Stem Cell Therapy
A joint venture of Stempeutics Research, a group company of Manipal Education & Medical Group and pharma giant Cipla has come up with a stem cell based biological product Stempeucel® for the treatment of Buerger’s Disease.
Drugs Controller General (India) granted limited approval for manufacturing and marketing of India’s first allogeneic cell therapy product, Stempeucel® for treatment of critical limb ischemia due to Buerger’s Disease.
Figure 1. Stempeucel® (Photo credit: Stempeutics Research)
Stempeucel® is the fifth “off-the-shelf” stem cell product which received approval by any regulatory body in the world. The first fully approved “off-the-shelf” allogeneic cell therapy was a mesenchymal stem cell (MSC) product, TEMCELL®HS Inj., launched this year in February by Japan based Mesoblast licensee, JCR Pharmaceuticals for treatment of acute graft versus host disease (aGVHD).
Thromboangiitis Obliterans popularly known as Buerger’s disease is a degenerative disease affecting the limbs. It is characterized by the progressive inflammation, swelling and clotting of small and medium blood vessels of the feet.
Figure 2. Pathophysiological phases of thromboangiitis obliterans (Photo credit: Circulation.
2010; 121: 1858-1861; doi: 10.1161/CIRCULATIONAHA.110.942383)
This condition gradually degrades the skin tissue, causes infection and gangrene. If unattended it may lead to amputation of all or part of a limb. Smoking or intaking tobacco in any form is found to be the major cause for this disease.
About 1,000,000 people in India and 2 per 10,000 persons in the European Community & USA are diagnosed with this disease.
Terms of the approval
Limited approval has been granted by Drugs Controller General (India) to manufacture and market Stempeucel®.
- The limited approval has been granted for up to 200 patients.
- A study carried out on the safety and efficacy of this drug in these 200 patients along with sufficient data should be submitted to the Government within 2 years to get full marketing and distributing authorization.
- Stempeutics has to ensure that the patients are not charged more than 1.5 lakhs as well.
Head of Cipla New Ventures, Chandru Chawla said, “Today is not only a great day for Stempeutics, but for everyone involved in the responsible development of stem cell therapies. Through Cipla Group’s investment in Stempeutics, we have brought the next generation of biologics to address unmet medical needs. Physicians now have an off-the-shelf stem cell therapy in their hand to fight Buerger’s disease. Much like the introduction of antibiotics in the late 1920’s, with stem cells we have now officially taken the first step into this new paradigm of medicine.”
Stempeutics, based in Bangalore was founded by Manipal Education and Medical Group (MEMG) in 2006. Later it entered into a liaison with India’s most customer- oriented 80 year old Cipla Pharmaceutical Company.
Figure 3. Clinical trials status of Stempeucel® (Photo credit: Stempeutics Research)
Stempeucel® is an allogeneic cell therapy designed to reduce inflammation and improve neovascularization thereby restoring the blood flow in ischemic tissue. It works based on anti-inflammatory and immune-modulatory mechanisms. It releases vascular endothelial growth factors, epithelial growth factors, angiopoietin and improves the perfusion thereby, repairing and regenerating the ischemic muscle tissue.
On a broader perspective this therapy could also be used for a broad spectrum of diseases that fall under the chronic critical limb ischemia.
The Making of Stempeucel®
180 ml of bone marrow was aspirated from three donors (60 ml each) who were shortlisted after a series of tests. Mesenchymal stem cells, the primary component of the drug was isolated from the bone marrow. From three donors more than 10 lakh doses of Stempeucel®, sufficient for next 10 years were produced.
Figure 4. The patented production process of Stempeucel® (Photo credit: Stempeutics Research)
Mr BN Manohar, CEO of Stempeutics said, “Obtaining DCGI approval for Stempeucel® is an important and historic milestone for Stempeutics. We are the FIRST Company in India to achieve such approval. It took almost 9 years to develop Stempeucel® for the treatment of Buerger’s Disease. European Medicinal Agency has classified Stempeucel® as an Advanced Therapeutic Medicinal Product (ATMP) and designated it as an Orphan Drug (ODD) for the treatment of Buerger’s Disease. Our goal is to globalize Stempeucel® for Buerger’s Disease and the market size is approx. US$ 1.5 Billion worldwide. We have conducted trials in India on 110 patients across multiple sites who have exhausted all options. It took the company nine years to develop the drug starting from the research to acquiring cells and producing the end product at a cost of 200 crore. We screened close to 20 donors through the ethics committee approval as per FDA standard.”
When Stempeucel® is globalized; positively by 2018 it can reach a market value of US $1.5 billion worldwide.
Featured image credit: Dividing stem cells (mitosis) © animaxx3d (Stock Photo ID: 122599739) and Stempeutics Research. Graphics remixed by Medgenera.