Indian Stem Cell Trial to Broaden Diabetic Foot Inclusion Criteria

Diabetic foot disease is the most common serious complication of diabetes and can lead to recurring wounds, frequently in the form of foot ulcers. The nerve damage and impaired blood circulation found in diabetics play a key role in ulcer formation. In severe cases, the affected limb must be partially or completely amputated.

While the study's design was formally approved by the Indian Council of Medical Research (ICMR) in June 2009 , the original inclusion criteria have proven prohibitively narrow, limiting subject enrollment and delaying the start of the study.

Dr. Anoop Misra , director of the trial, explained that the inclusion criteria were based on pilot studies conducted in China . "Out of over 150 patients screened, only one subject fit our original criteria." He went on to suggest that diabetic foot disease experienced in a clinical setting may have differing characteristics in India and China . Fortis notified the Indian Council of Medical Research of the need to revise the inclusion criteria, and it can now move forward. The trial was scheduled to start in July and to include a total of 36 patients, of whom 12 are to be randomly selected to receive stem cell treatment.

The trial's focus is on healing diabetic foot ulcers with stem cells. If effective, the treatment should improve blood perfusion in the ischemic area of the lower limb. This improvement will be assessed by measuring the change in transcutaneous partial pressure of oxygen (TCpO2), and will also involve NMR angiography of the local vessels, assessment of ulcer healing, pain relief, limb salvage, and the ABI index. Diabetic foot disease is a serious issue in India . A successful trial will have significant implications for future treatment of the condition.

"Many of our stem cell treatments to date have focused on rare and otherwise incurable conditions. This study marks an important step in verifying the applicability of stem cell therapies to more commonly occurring, serious pathologies," said Dr. Sean Hu , CEO and Chairman of Shenzhen Beike Biotechnologies Co. Ltd., regarding the implications of the study. Hu continued, "The Chinese pilot trial yielded promising results which is encouraging for everyone who deals with patients affected by diabetic foot disease or related ischemic complications. As with all scientific advancements, it is important to demonstrate that it is effective and reproducible in the broader international setting. The replication of this study in India will both underline the effectiveness of the treatment protocol we have developed and demonstrate that it can be applied by the international medical community."

The preceding study in China produced promising results, increasing blood perfusion, markedly reducing ulceration, and raising TCpO2 levels. In some cases patients regained function in limbs that had been candidates for amputation.

Lalit Jaiswal , CEO of Beike Biotech India Private Company Limited, added, " China has been at the forefront of stem cell technology for several years, and this study is a logical next step for the company. It is exciting that we will now be able to examine the potential of peripheral blood-derived stem cells to induce neovascularization," Lalit continued, "The clinical value of bone marrow stem cells has been known for years, and we hear about fetal and embryonic stem cells in the news every day. In this study, though, we are processing a patient's own blood to isolate stem cells and then using these stem cells to treat their diabetic foot ulcers and circulatory problems. When this trial is over we will have confirmed whether a diabetic patient's own peripheral blood can be used to induce the growth of new blood vessels in their damaged tissue."

The clinical trial is officially titled, "A Randomized, Controlled, Parallel Design, Safety and Efficacy Study of Granulocyte Colony Stimulating Factor Mobilized Autologous Peripheral Blood Mononuclear Cell Therapy in Subjects With Diabetic Limb Ischemia." India's Council of Medical Research approved the study after verifying that it met all associated criteria in terms of design and controls as well as following ethical and safety standards.

"The large number of people who applied to enroll in this study confirms that there is strong demand for this therapy and a need to augment current treatment methods. However, to enroll enough subjects for a successful study we have determined that we must broaden the inclusion criteria and reapply to ICMR. Now that we have notified the ICMR we will restart the trial in October," said Dr. Anoop Misra.

About this Clinical Trial

For more information, please use this trial's ID: NCT00922389 on the U.S. National Institute of Health's Clinical Trial Listings: http://www.clinicaltrials.gov

About Fortis Healthcare, India

Fortis Healthcare Limited ( http://www.fortishealthcare.com ), a leading healthcare consultancy in India , has a vision of "creating a world-class integrated healthcare delivery system in India , combining the finest medical skills with compassionate patient care."

Fortis Healthcare Limited is one of the leading chains of hospitals and is a leader in healthcare consultancy in India , benchmarked to international standards -- achieving quality through the relentless adherence to the protocols observed at leading hospitals around the world.

About Beike Biotech India Private Company Limited

Beike Biotech India Private Company Limited is associated with Shenzhen Beike Biotechnologies Co. Ltd. Its primary focus is to sponsor clinical trials utilizing stem cell products derived from umbilical cord, cord blood, and bone marrow stem cells. Beike's proprietary processing and quality assurance technologies prepare stem cells for use in treating a variety of serious medical conditions such as brain injury, the ataxias, cerebral palsy, diabetic foot disease, lower limb ischemia, multiple sclerosis, muscular dystrophy, spinal cord injury and optic nerve damage.