Company's flagship product is "stempeucel®". It is based on allogeneic mesenchymal stem cells derived from bone marrow of healthy, adult voluntary donors. Stempeutics has completed preclinical studies demonstrating the safety and efficacy of "stempeucel®" and currently focusing on indications covering the disease areas of Cardiovascular, Orthopaedics, Endocrinology, and Gastroenterology, where it believes that "stempeucel®" can improve the clinical outcomes substantially. Stempeutics is the FIRST Company to get approval from DCGI (Indian FDA) for conducting stem cell clinical trials in India in 2009 and from NPCB (Malaysian FDA) in 2011.
Currently three Phase 2 clinical trials are in progress in India which are approved by DCGI i.e. Critical Limb Ischemia (CLI), Osteoarthritis (OA) and Liver Cirrhosis (LC). Stempeutics is planning to complete OA & CLI Phase 2 trial by middle of 2013 and likely to file for Phase 3 by end of 2013 based on the outcomes of Phase 2 trial. Stempeutics has also received approval from DCGI to conduct Phase 2 clinical trials for Chronic Obstructive Pulmonary Disorders (COPD) and Diabetes Mellitus Type-II (DM). These two trials are yet to start. In Malaysia, Stempeutics is currently conducting OA Phase 2 trial. Stempeutics has also received NPCB approval for Phase 1/2 Ischemic Cerebral Stroke (CS) trial. This trial is yet to start.
With three Phase 2 trials in progress, Stempeutics aims to bring out their first product into the Indian and Malaysian markets in 2015. Stempeutics long-term objective is to market "stempeucel®" in the Asian, European and North American markets.
Stempeutron is an innovative point-of-care, fully automated stem cell isolation device - to obtain a population of cells, collectively known as the stromal vascular fraction (SVF) from adipose or fat tissue. Autologous SVF cells have significant potential in plastic and reconstructive surgery applications such as soft tissue augmentation for post mastectomy breast reconstruction / cosmetic breast augmentation, facial restructuring, deformity correction, scar and wrinkle reduction etc. Stempeutron will be the FIRST device to be developed indigenously, complying with international regulatory standards, and will be based on an entirely novel process and technology as compared to the few existing devices worldwide for cosmetic and reconstructive therapy. The Alpha phase of the device development is completed and the Beta phase development is in progress. Stempeutics is planning to launch Stempeutron device in 2014 for the Asian market.
stempeucare is a novel product from the Conditioned Medium, for Cosmetic applications. It is a topical application product. Initial proofs of concept studies have shown encouraging results and the product is undergoing further development for Skin Health & Hair Growth. Conditioned Medium derived from BM-MSCs contain a large number of cytokines and growth factors that can facilitate creating a favorable localized microenvironment for enhanced tissue regeneration/repair, cyto-protection,neovascularization etc. by activating resident stem cells in the niche environment via paracrine mechanism. Stempeutics has quantified about 30 growth factors/cytokines in the conditioned medium which plays an important role in tissue regeneration/repair. Based on the patent pending production technology Stempeutics produces consistently homogeneous conditioned medium which can be used to develop cosmetic products having applications in anti-ageing and anti-wrinking of skin; and hair growth promotion. Stempeutics is planning to launch this product in 2014.