Senior Consultant Vascular and Endovascular surgeon, Ramaiah Memorial Hospital, Bengaluru, India.
Head of Department, Vascular Interventions and Surgery, Fortis Escorts Heart Institute, New Delhi, India.
Stem Cell Res Ther. 2024 Oct 8;15(1):352. doi: 10.1186/s13287-024-03957-0.
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.
慢性肢体威胁性缺血(CLTI)是一种具有高发病率和死亡率的挑战性临床问题。血管内介入治疗一直是治疗的基石。据估计,CLTI 占所有外周动脉疾病患者的<10%,但在一年内,50%的患者最终要么下肢进行大截肢,要么死于心血管原因,尤其是那些血管重建不成功或“无选择”CLTI 的患者。基于细胞的治疗方法,特别是骨髓来源的间充质基质细胞,已成为 CLTI 治疗的一种有潜力、有前途和新颖的替代治疗方法,在众多研究中取得了积极的结果,包括随机和非随机试验。REGENACIP 是印度中央药物标准控制组织批准的一种 BM-MSC 疗法,用于治疗 Rutherford 分级 III-5 或 III-6 期已确诊的严重肢体缺血、不适合或已失败传统血管重建治疗、伴有静息痛和/或受影响肢体溃疡的“无选择”动脉粥样硬化性外周动脉疾病/伯格氏病患者。本综述旨在讨论 CLTI 的各个方面及其在 REGENACIP 中的临床获益。