Singapore, Sep 17, 2009: Fortis Healthcare, one of India's leading private hospital groups, has said that it will broaden inclusion criteria for its upcoming diabetic foot clinical trial. The study will use stem cells derived from peripheral blood to treat critical limb ischemia (diabetic foot).

 

Current treatment of diabetic foot ulcers involves intensive wound management, risk reduction and lengthy rehabilitation. The current treatments available for diabetic foot are both expensive and labor intensive. The study will determine whether stem cells can be effectively used to treat and facilitate faster recovery for this condition. The trial is being sponsored by Beike Biotech India Private Company Limited.

 

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, regarding the implications of the study. Dr 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.

 

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 Misra.