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Diabetic foot disease is the most common serious complication of diabetesand can lead to recurring wounds, frequently in the form of foot ulcers. Thenerve damage and impaired blood circulation found in diabetics play a key rolein ulcer formation. In severe cases, the affected limb must be partially orcompletely amputated.
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While the study's design was formally approved by the Indian Council ofMedical Research (ICMR) in June 2009, the original inclusion criteria haveproven prohibitively narrow, limiting subject enrollment and delaying thestart of the study.
Dr. Anoop Misra, director of the trial, explained that the inclusioncriteria were based on pilot studies conducted in China. "Out of over 150patients screened, only one subject fit our original criteria." He went on tosuggest that diabetic foot disease experienced in a clinical setting may havediffering characteristics in India and China. Fortis notified the IndianCouncil of Medical Research of the need to revise the inclusion criteria, andit can now move forward. The trial was scheduled to start in July and toinclude a total of 36 patients, of whom 12 are to be randomly selected toreceive stem cell treatment.
The trial's focus is on healing diabetic foot ulcers with stem cells. Ifeffective, the treatment should improve blood perfusion in the ischemic areaof the lower limb. This improvement will be assessed by measuring the changein transcutaneous partial pressure of oxygen (TCpO2), and will also involveNMR angiography of the local vessels, assessment of ulcer healing, pain relief,limb salvage, and the ABI index. Diabetic foot disease is a serious issue inIndia. A successful trial will have significant implications for futuretreatment of the condition.
"Many of our stem cell treatments to date have focused on rare andotherwise incurable conditions. This study marks an important step inverifying the applicability of stem cell therapies to more commonly occurring,serious pathologies," said Dr. Sean Hu, CEO and Chairman of Shenzhen BeikeBiotechnologies Co. Ltd., regarding the implications of the study. Hucontinued, "The Chinese pilot trial yielded promising results which isencouraging for everyone who deals with patients affected by diabetic footdisease or related ischemic complications. As with all scientific advancements,it is important to demonstrate that it is effective and reproducible in thebroader international setting. The replication of this study in India willboth underline the effectiveness of the treatment protocol we have developedand demonstrate that it can be applied by the international medicalcommunity."
The preceding study in China produced promising results, increasing bloodperfusion, markedly reducing ulceration, and raising TCpO2 levels. In somecases patients regained function in limbs that had been candidates foramputation.
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 wewill now be able to examine the potential of peripheral blood-derived stemcells to induce neovascularization," Lalit continued, "The clinical value ofbone marrow stem cells has been known for years, and we hear about fetal andembryonic stem cells in the news every day. In this study, though, we areprocessing a patient's own blood to isolate stem cells and then using thesestem cells to treat their diabetic foot ulcers and circulatory problems. Whenthis trial is over we will have confirmed whether a diabetic patient's ownperipheral blood can be used to induce the growth of new blood vessels intheir damaged tissue."
The clinical trial is officially titled, "A Randomized, Controlled,Parallel Design, Safety and Efficacy Study of Granulocyte Colony StimulatingFactor Mobilized Autologous Peripheral Blood Mononuclear Cell Therapy inSubjects With Diabetic Limb Ischemia." India's Council of Medical Researchapproved the study after verifying that it met all associated criteria interms of design and controls as well as following ethical and safety standards.
"The large number of people who applied to enroll in this study confirmsthat there is strong demand for this therapy and a need to augment currenttreatment methods. However, to enroll enough subjects for a successful studywe have determined that we must broaden the inclusion criteria and reapply toICMR. Now that we have notified the ICMR we will restart the trial inOctober," 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 leadinghealthcare consultancy in India, has a vision of "creating a world-classintegrated healthcare delivery system in India, combining the finest medicalskills with compassionate patient care."
Fortis Healthcare Limited is one of the leading chains of hospitals and isa leader in healthcare consultancy in India, benchmarked to internationalstandards -- achieving quality through the relentless adherence to theprotocols observed at leading hospitals around the world.
About Beike Biotech India Private Company Limited
Beike Biotech India Private Company Limited is associated with ShenzhenBeike Biotechnologies Co. Ltd. Its primary focus is to sponsor clinical trialsutilizing stem cell products derived from umbilical cord, cord blood, and bonemarrow stem cells. Beike's proprietary processing and quality assurancetechnologies prepare stem cells for use in treating a variety of seriousmedical conditions such as brain injury, the ataxias, cerebral palsy, diabeticfoot disease, lower limb ischemia, multiple sclerosis, muscular dystrophy,spinal cord injury and optic nerve damage.For more information, please contact: T. Gutmann Shenzhen Beike Biotech Company, Ltd. Shenzhen Hi-Tech Industrial Park Tel: +86-0755-8611-0575 Email: [email protected] Web: http://www.beikebiotech.com
SOURCE Shenzhen Beike Biotechnology Co. Ltd.
