Tissue Genesis, LLC Provides Cell Isolation Processing for Patients with Critical Limb Ischemia (CLI) in Ukrainian Clinical Study
Study to investigate whether adipose-derived SVF therapy can reduce amputation, speed up wound healing and increase ambulatory function.
Tissue Genesis, LLC, the leading provider of cell isolation technology is pleased to announce that the Icellator® is being used to generate therapeutic cell preparations at the V.P. Komisarenko Institute of Endocrinology and Metabolism in Kiev, Ukraine, for patients with critical limb ischemia (CLI). The autologous stem-cell therapy, which utilizes a patient’s own fat cells, is the first of its kind in Ukraine to treat CLI patients. This effort will build on previous stem cell studies that have shown promising results as a potential therapeutic option for this debilitating and increasingly common vascular disease.
Six patients were treated in the opening week in the open-label registry study. The CLI patients are treated with their own stem cells in a series of direct intermuscular injections into the lower limbs. The surgical team, led by Dr. Yuri Tarashchenko, and the research team, led by Dr. Svitlana Bolgarska, PhD, will follow patients to determine whether SVF therapy reduces amputation, accelerates wound healing or increases ambulatory function. Lower limb blood pressure and quality of life surveys will also be assessed throughout the follow up.
“This study is an alternative way to achieve limb salvage for patients with Critical Limb Ischemia,” explained Dr. Bolgarska. “I am glad to report that all of our patients are recovering well and feeling good. I am looking forward to seeing the results of our study and I am optimistic that there will be positive results.”
Dr. Marc Penn, Tissue Genesis’ Chief Medical Officer, traveled to Kiev to oversee the first treatment week. He was joined by Dr. Bart Rademaker, a plastic surgeon and clinical consultant who provided training in the liposuction technique to obtain a patient’s adipose tissue and prepare it for cell processing. The study was organized with the help of Faon LLC, a Ukrainian company.
“It is exciting to bring autologous cell therapy to patients in Ukraine with critical limb ischemia who otherwise would be at risk of losing their limb,” said Dr. Penn. “Collaborating with the expert clinicians in the Ukraine who offer their patients excellent state of the art care, to bring stem cell therapy to their patients has been equally rewarding.”
As the leader in the production of stromal vascular fraction (SVF) from a patient’s own adipose (fat)-derived stem cells, the Icellator® is a state-of-the-art, enzyme-derived cell isolation system. The totally enclosed, fully automated process is designed to minimize the risk for human error and contamination. The Icellator® has a sterile, single-use, disposable cartridge kit per patient and uses a patented, purification process to obtain a consistent yield of SVF.
“Tissue Genesis is committed to providing the most advanced cell processing technology to address the unmet medical needs in vascular diseases, including CLI,” said General Manager Ben Chlebina. “The Icellator® allows physicians access to active stem cell preparations to treat their patients without the need to build an expensive cell isolation infrastructure or support a large scientific team. We are excited to expand our clinical program into new markets and offer therapeutic options for populations with chronic conditions and diseases.”
ABOUT CRITICAL LIMB ISCHEMIA
Critical limb ischemia, also known as chronic limb-threatening ischemia, is a condition where lack of blood flow to an extremity, such as an arm or leg, inhibits normal metabolic function. CLI can lead to pain, skin ulcers and dermal sores, and, if not successfully addressed, amputation. It can also put patients at a higher risk for cardiovascular complications, and death. CLI is considered the “end stage” of peripheral arterial disease (PAD). Currently, CLI affects approximately 200 million people worldwide. As the population ages and the prevalence of diabetes, obesity and chronic kidney disease rises, so will the incidence of peripheral arterial disease and, consequently, CLI.
ABOUT TISSUE GENESIS
Tissue Genesis, LLC, (TG) offers best-in-class, clinical grade cell therapy solutions. Its state-of-the-art Icellator® is a high-performance, point-of-care device that efficiently extracts adult stem cells from a small sample of autologous adipose tissue in an enclosed and automated process. Manufactured under cGMP to the highest ISO 13485 and FDA standards, the Icellator® provides yields of stromal vascular fraction that is sufficiently pure to allow for intravenous infusion in an hour or less. Tissue Genesis’ Icellator® is approved for use by medical regulatory authorities in South Korea, Ukraine and the Bahamas, and is working to obtain regulatory approval for its cell therapy products in Japan and the US, with ongoing FDA-cleared trials for multiple indications of chronic disease.