Critical Limb Ischemia (CLI) is a serious end-stage manifestation of peripheral artery disease. CLI consists of a combination of three separate conditions, each more devastating than the other.  Ischemic rest pain is experienced as an uncomfortable burning sensation in the feet and lower legs aggravated by resting states such as sitting or reclining and is very similar to the early stages of diabetic neuropathy. It is alleviated by dangling the legs from the side of the bed. Tissue loss, as the name implies, can be “surface” damage presenting as ulceration; or deeper, severe ischemia (shortage of blood) presenting often later as gangrene. If not treated promptly, CLI has a very negative prognosis, with an amputation rate of 25% within the first year following diagnosis. Recently, the attention of researchers has turned to the possibility of cell-based therapies to treat critical limb ischemia with the goal of decreasing the need for amputation and increase the affected patients’ quality of life.

SVF – Pilot Study

In a pilot study conducted in 2015, fifteen patients between the ages of 35 and 77 for whom amputation was determined to be the only viable treatment option were given a series of injections of SVF cells. The SVF injection consisted of a multitude of regenerative cells derived from the patient’s own adipose (fat) tissue. These multi-functional stem cells are easily extracted utilizing a simple outpatient procedure, and provide a much readier source of regenerative potential than previous cell-based therapies. Before this study, bone marrow-derived stem cells and those found in peripheral blood cells were proven to deliver effective outcomes, but the difficulty in accessing and processing the cell cultures makes these therapies both invasive and cost prohibitive for most. Adipose SVF cells are widely recognized as abundant, accessible and reliable in the treatment of a variety of diseases, and can be removed from the patient without any functional defect whatsoever and at negligible risk. Therefore, researchers were confident that patients suffering from CLI could benefit from adipose-cell therapy. It is important to note that the muscle tissue as well as the connective tissue in between, where the SVF cells were implanted, is classified as mesenchymal tissue, as is the SVF itself. Combined with the fact that the SVF is uncultured and taken from the patient’s own tissues, this therapy is considered homologous. Given recent regulatory concerns about the application of SVF as a “medicine” versus a therapy modality, researchers felt that the study of uncultured, autologous SVF in the treatment of disease was an important area of study to focus on going forward.

Following multiple intramuscular and peri-muscular injections of SVF at the site of pain and ulceration, none of the patients reported any complications during follow-up. Overall, 86.7% showed a marked, clinically significant improvement. The majority of patients reported diminished resting pain, and all ulceration healed over with no recurrence reported. Most significantly, rather than simply halt the progressive damage of CLI, the SVF therapies restored the damaged tissue by forming multiple vascular collateral networks across the affected arteries by processes known as angiogenesis and neovascularization.

SVF – Valuable Regenerative Resource

Thanks in part to studies such as this one, stromal vascular fraction is beginning to be respected in the medical community as a viable source of valuable, regenerative cells; adding another resource in the armamentarium treating defiant cases of leg ischemia. Compared to bone marrow-based stem cell treatments (BM-MSCs), adipose-derived SVF can provide enough cells for a therapeutic measure without cell culture. It does not degrade or diminish with age as the percentage of MSCs in bone marrow does with age and health condition, and doesn’t require a major invasive procedure to harvest. Autologous SVF from adipose tissue was once discarded as “medical waste,” but now is recognized as an abundant source of multipotent stromal stem cells, and has proven effective in the treatment of a wide array of conditions. In this study alone, SVF aided in the healing of ischemic muscle and connective tissue as well as regenerating the lost skin of ulcers. Previous studies have shown SVF to be similar in aiding diabetic wound in healing. For the first time, it has been shown that injections of uncultured SVF cells accelerate the formation of new blood vessels (angiogenesis). The results obtained from this study alone demonstrate the beneficial nature of SVF cell therapy in re-growing tissue, reducing pain, and giving CLI patients the possibility of a future with all their limbs intact.

At Gulf Coast Stem Cell Regenerative Center, which is an affiliate partner of the Cell Surgical Network, we conduct patient-funded research with the intention of treating patients with their own autologous stem cells. We aid in the management of ischemic, degenerative, inflammatory, and autoimmune conditions, and our highly skilled team of providers is committed to the goal of alleviating symptoms and enhancing functionality. For more information about Gulf Coast Stem Cell & Regenerative Medicine Center, the disorders we currently address, or to set up a FREE phone consult with Dr. Barmada, please call (866) 885-4823 or fill out our contact form.

Gulf Coast Stem Cell & Regenerative Medicine Center is located at 1153 Ocean Springs Rd, Ocean Springs, MS, 39564, but we offer our services throughout the Gulf Coast States, including Alabama, Louisiana, Florida, Texas, as well as throughout the United States. For more up-to-date information about our innovative technology, review our website, check our FAQ’s, and watch our patient testimonials.

Original Research Article

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