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First Evidence that Adipose Stem Cell-Based Critical Limb Ischemia Treatment is Safe & Effective is published in Circulation Journal by Lead Investigator Dr. Han Cheol Lee of Pusan National University
Date:9/4/2012

SEOUL, South Korea, Sept. 4, 2012 /PRNewswire/ -- Korean researchers, reporting the results of a major study in the Circulation Journal, found that the transplantation adipose (fat) derived stem cells resulted in the regeneration of blood vessels in patients who were otherwise expecting to receive limb amputations due to damaged arteries and lack of blood circulation.

Researchers at Pusan National University, led by Dr. Han Cheol Lee, describe how patients with critical limb ischemia (hereafter, CLI, example of which include Buerger's Disease and diabetic foot ulcers) were injected with adipose tissue-derived mesenchymal stem cell manufactured by RNL BIO.

As a result of the remarkable adipose stem cell process of RNL BIO, researchers found that immediate new blood vessel generation was identified. (The title of article is "Safety and Effect of Adipose Tissue-Derived Stem Cell Implantation in Patients With Critical Limb Ischemia")

CLI results from lack of circulation due to small artery damage and subsequent tissue necrosis. Patients with severe CLI often face limb amputation. Buerger's Disease, or diabetic foot ulcer, are of the same kind. Risk factors are diabetic mellitus, hypertension, high cholesterol and smoking. There is no known cure to date.

Currently percutaneous transluminal angioplasty or PTA may treat 60-70% of patients with CLI, but it doesn't work with those who suffer from Buerger's Disease. Working under approval to conduct compassionate use research of stem cell to treat CLI by intra-muscular injection of adipose tissue derived stem cells in December, 2008 (KFDA IND approval # 1273), the researchers in this study enrolled 15 subjects: 12 with Buerger's Disease, and 3 with Diabetic foot ulcers. 300 million stem cells were injected into each patient's leg.  No complications were observed, even six months after injection.

Only five patients, as they all had expected, required minor amputation during follow-up, and all amputation sites healed completely. At 6 months, significant improvement was noted in pain and in claudication walking distance. Digital subtraction angiography before and 6 months after ATMSC implantation showed formation of numerous vascular collateral networks across affected arteries.

Dr. Jeong-Chan Ra, President of RNL Stem Cell Technology Institute, said, "This new therapy through adipose tissue derived mesenchymal stem cell is expected to offer new hope for patients with CLI, hope that had been difficult to find before."


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SOURCE RNL Stem Cell Technology Institute
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