Mesenchymal stromal cell therapy (REGENACIP®), a promising treatment option in chronic limb threatening ischemia – a narrative review
Soaham Desai, Digvijay Sharma, Rajesh Srinivas, Balaji Venugopal, Vijay Thakore, Varinder Singh Bedi, Ravul Jindal, Amarnath Sugumaran, Senthilnathan Mohanasundaram, Jaideep Gogtay, Pawan Kumar Gupta, Aniruddha Bhuiyan, Gnaneswar Atturu
Abstract
Abstract Chronic Limb Threatening Ischemia (CLTI) is a challenging clinical problem associated with high morbidity and mortality. Endovascular interventions have been the cornerstone of treatment whenever possible. It is estimated that CLTI represents < 10% of all Peripheral Artery Disease patients, yet 50% of the patients end up either with a major amputation of the lower limbs or die of cardiovascular causes within one year period, especially in those with unsuccessful revascularization or “no-option” CLTI. Cell-based therapeutics, especially bone marrow-derived mesenchymal stromal cells have emerged as a potential, promising, and novel alternate therapeutic modality in the management of CLTI, bolstered with positive results in numerous research, including randomized and nonrandomized trials. REGENACIP ® is one such BM-MSC therapy approved by Central Drugs Standard Control Organization in India for the management of “no-option” Atherosclerotic Peripheral Arterial disease / Buerger’s disease patients with established critical limb ischemia in Rutherford Grade III-5 or III-6, not eligible for or have failed traditional revascularization treatment, with rest pain and / or ulcers in the affected limb. The current review aims to deliberate upon the various aspects of CLTI and clinical benefits of REGENACIP ® therein.