LifeCell International India’s first & the largest stem cell banking service provider, which has also pioneered in stem cell research and technology, today announced its association with Harvest Technologies, a world leader in developing technologies that accelerate natural healing, to bring-in a next generation technology Bone Marrow Aspirate Concentrate (BMAC) system in India. BMAC is a USFDA and CE approved biological technology that accelerates the body’s natural healing capacity, thereby improving surgical outcomes.

Existing methods to produce a stem cell concentrate therapy are time consuming, labour intensive, and require complex logistical considerations. The BMAC System helps in safe and rapid preparation of cell concentrate from bone marrow. The process takes only about 15 minutes and can be conducted in the point of care setting.

The system is currently being used clinically in many developed countries like US and Europe for various medical disciplines. These applications range from fractures, non-unions, osteonecrosis, cartilage repair applications and critical limb ischemia (CLI). The system will soon be applied for cardio vascular regeneration.

LifeCell has implemented this technology for an ongoing Indian CLI study which is being led by Dr. K. S. Vijayragavan at Department of Vascular Surgery, SRMC. As per the data available on the interim study conduted on 30 patients after a 12 week followup major amputations were seen only in 4 patients and 6 of them went for minor amputation. The patients’s also reported significant reduction in their pain perception and considerable improvement in quality of life. The study also emphasised the fact that the BMAC process is safe and the Intra-arterial infusion does not cause any adverse reaction.

Talking on the association with Harvest Technologies, Mr. Mayur Abhaya, Executive Director, LifeCell International says, “We are excited to partner with Harvest Technologies to bring-in international standards to India. LifeCell International is today India’s only comprehensive stem cells solutions provider as we offer a complete spectrum of services and with this association we intend to accelerate the availability of advanced stem cell therapy in India.

According to Scott Shea, Managing Director, Harvests Technologies GmbH, “The Autologous regenerative cells from bone marrow offer profound potential for therapies. Harvest has conducted about 30,000 clinical procedures for various applications, the highest number of procedures in the world, using the BMAC System. Our novel technology now makes it possible to harvest the regenerative cells safely and rapidly in order to develop new therapies for heretofore incurable diseases.”
“We are delighted to be associated with LifeCell, an undisputed market leader in stem cell technology space and extend our services in India.  LifeCell has a well established network with hospitals and clinical institutions across India and we would leverage their strength to rapidly deploy our service across the country and provide HOPE in addressing unmet medical challenges by offering cellular therapeutic options.”

Commenting on the interim report presented on the studies conducted for CLI in India using the BMAC technology, Mr. Mayur added, “Through our clinical research, we have identified that the transplantation of autologous Bone Marrow Aspirate Concentrate (BMAC) into critically ischemic leg can increase blood flow and support in healing the wounds quickly. It also helps in reducing pain and avoiding leg amputation of otherwise incurable patients. This is also validated by the outcome of the CLI study which showed that 86.6% of patients could avoid amputation.”

Cord Blood Stem Cells

Blood can be collected from the umbilical cord of a newborn baby shortly after birth. This blood is rich in blood stem cells that can be used to generate red blood cells and cells of the immune system. Cord Blood stem cells can be used to treat a range of blood disorders and immune system conditions such as leukaemia, anaemia and autoimmune diseases. Once collected, cord blood can be stored in a cord blood bank and would be available for use by the donor and compatible siblings.

Alternatively, the cord blood may be donated to a general cord blood bank for use by other tissue matched individuals in need of a transplant. It is hoped that over time a store of cord blood stem cells from people of different tissue types may be established. Someone requiring a transplant would be treated with stem cells from the sample most closely matching their own tissue type, thus minimising complications associated with immune rejection.

Cord blood stem cells may also be useful for treatment of diseases other than blood disorders. Preliminary research reports suggest that cord blood stem cells may have a greater ability to differentiate into different cell types than was previously thought possible. Using animal model, several research groups have used human cord blood stem cells to treat heart attacks and repair injured blood vessels. However, this research is at a very early stage. Scientists are presently unsure whether the cord blood stem cells are transformed into heart muscle or blood vessels, or if they secrete growth factors, that trigger repair. If further studies and clinical trials prove successful, cord blood stem cells may provide a new treatment for cardiovascular disease with fewer side effects than current drug based and surgical treatments.

Ethical Issues

The use of cord blood stem cells in cell-based therapies for blood and immune diseases, and for other potential applications, would be welcomed by the majority of the community. Although cord blood stem cells are less versatile than Embryonic Stem cells, their use in research is less controversial as it does not involve the destruction of embryos. Their potential use for cell-based therapies is also attractive as it would be possible to use a patient’s own cord blood stem cells to generate tissue for transplantation, thus avoiding problems with immune rejection.

.Saviour Siblings

Controversy has arisen over the practice of genetically selecting embryos created during infertility treatment, for the purpose of using the donor baby’s cord blood to treat an ill sibling. In this procedure, genetic testing is performed to ensure that the embryo will provide cord blood devoid of the genetic defect afflicting the sibling, but which matches the sibling’s genetic make up. The donor baby in this case is sometimes referred to as a ’savior sibling’.

The first ’saviour sibling’ to be born in Australia was reported in March 2004. A Tasmanian couple used this technology to have a second child who was free of a genetic condition, Hyper IgM Syndrome. Cord blood from this child could be used to treat the affected sibling. As a result of this selection process carried out Sydney IVF Clinic, the woman started her pregnancy knowing that her baby was free of Hyper IgM Syndrome and would be a potential tissue donor for her existing son.

The creation of ’saviour siblings’ has evoked a quite heated debate in both the medical and general community. Some are vehemently opposed to this application, considering this the first step in ‘designer babies’. Others consider it highly unethical not to use this technology to help the sick sibling. The overarching issue to be considered is the well being of the ’savior sibling’, and to ask the question whether they will be disadvantaged by the procedure. These are questions to be considered by both the biomedical and general community when considering applications of any new technology.