Clinical trial the MSCs therapy in limb ischemia: choose the best method

Document Type : Review


Vascular and endovascular surgery research center,Mashhad university of medical science


Introduction and Objectives

There is a substantial amount of data provided in preclinical research and recently made early clinical efforts to evaluate the positive MSC therapy in Limb ischemia disease impacts. The present review is primarily focused on assessing various limb ischemia-related human MSC clinical trials to select the best technique with the highest limb ischemia-related clinical trial MSC efficacy. Five studies met the criteria to be included in this review. MSCs originating from bone marrow Allogenic MSC, bone marrow autogenous MSCs, HUCB MSCs were administered. The injection was intramuscular, Intravenous, and intravenous. The mean follow-up time was between 6 to 60months after MSC therapy. All studies reported improvement from baseline in at least 1 clinical outcome measure, and no study reported major adverse events attributable to MSC therapy. In clinical assessments, the selection of the best method could improve treatment efficacy. Several factors may be involved in the MSC injection efficacy of limb ischemia patients. Both allogeneic and autologous exhibited positive results over placebo. However, it is should be mentioned that autologous MSC investigation has higher cost and toxicity. To reduce the toxicity of derived MSCs while injection, particularly in arterial and intravenous injection, different injection doses can be performed. MI injection at different doses is the best method for diminishing the side effects. To evaluate injection efficacy, different criteria can be adopted, including angiography, ABI index, ulcer healing and amputation, and pain-free walking distance follow-up for up to five years.