Chennai-based Lifecell International (P) Ltd and the US based medical device company, Harvest Technologies, have received the approval from DCGI for promoting BMAC (Bone marrow aspirate concentrate) kits in Indian Market.
Sources from the Lifecell said BMAC System is an easy to use, point of care, autologous system that can rapidly produce a concentration of mononuclear cells (MNC) consistent with those concentrate reported in numerous human clinical trials. Existing methods to produce a stem cell concentrate therapy are time consuming, labour intensive, and require complex logistical considerations.
The BMAC System conveniently processes either 60mls or 120mls of bone marrow aspirate within a 15 minute process step that can be conducted in the point of care setting. It produces a MNC concentrate that is unsurpassed in the number of cells the system can yield as well as ensuring that the cells remain viable during the process. A typical yield from processing just 60mls of aspirate is over 220 million MNC’s of which approximately 10 million are CD34+ with over 3200 Colony Forming Units (CFU’s).
The System is approved for clinical use in Europe, cleared by the US FDA for use in the United States. The system is currently being used clinically in Europe for various medical disciplines ranging from orthopaedic bone fusion applications such as fractures, non-unions, osteonecrosis, and cartilage repair applications to peripheral arterial disease (PAD) applications such as treating end-stage critical limb ischemia (CLI).
The recent clinical trial on CLI conducted in Sri Ramachandra University, Chennai along with their clinical research wing ‘Tricell’ has got phenomenal results in which more than 90 per cent of the cases were saved from amputation (Limb Salvage) in PAD(Peripheral arterial Disease) patients. Critical limb ischemia is a persistent and relentless problem, which severely impairs the patient functional status and quality of life, and is associated with an increased cardiovascular mortality and morbidity.
Autologous cell therapy has been studied as an innovative treatment option for CLI, however; previously published studies did not use a rapid, point of care method for processing the cells therefore making widespread adoption of the therapy problematic.
The Harvest trial, which enrolled the largest number of subjects of any study to date, utilized the BMAC system to process bone marrow aspirated from the patient in order to produce a highly concentrated composition of multi-potent nucleated cells. The BMAC system is unique in that and it can produce this cellular composition in 15 minutes within the operating room. A unique feature of the trial was to compare the relative effectiveness of two different delivery methods.