Treatment Strategies in No Option Critical Limb Ischaemia

A 70-year-old male, with a non-healing ulcer in the left leg for three months and in severe rest pain for four months, came to Max Super Speciality Hospital, Shalimar Bagh. He was not able to sleep and complained of continuous dull aching pain that got worse during the night. The patient had a history of smoking for the last 50 years, smoking 20-30 beedis per day. A CT angiogram was performed which showed very poor distal run-off. Still, an attempt for revascularisation was made, and tibial vessels were explored but found to be chronically occluded.

The patient was put on the best optimal medical management and analgesics to alleviate pain. Still, the patient had a poor response, and he underwent disarticulation of 4 and 5 toes in view of gangrene after two months. The patient had no relief, and as a case of no option Critical Limb Ischaemia (CLI), the doctors planned the patient for stem cell therapy REGENACIP (which is a formulation of Bone marrow mesenchymal stromal cells (BMMSC). The patient underwent injection in the calf muscle so that it could initiate angiogenesis and immunomodulation at the recommended dose of 2 million cells /kg/bodyweight. It was done as a care procedure and without any major complications.

At three weeks of follow-up, his rest pain has been completely relieved, and he has an active healing ulcer. The use of this approach to stem cell therapy is expected to not only modulate the outcome of intended therapy but also will be a feasible option for cost-effectiveness in patients with no option CLI in the near future.

Critical Limb Ischemia (CLI) is the most dangerous stage of peripheral artery disease (PAD) caused by distal tissue hypoxia injury and lack of blood supply, including distal extremity ischemia, ulcers, or gangrene. The prevalence of PAD in the general population is 3% to 10%. The data showed that 11.2% of patients with PAD would deteriorate to CLI each year, and the patient with CLI has the highest amputation and mortality rates.

Currently, patients in PAD could be treated by percutaneous transluminal angioplasty (PTA) or intravascular thrombolysis; however, 10%–30% of patients with CLI are not candidates for revascularisation surgery. Many patients lose the chance of PTA, and the prognosis is poor after surgery because the patients have peripheral atherosclerosis obliterans, extensive vascular disease, and/or serious damage caused by severe ischemic lesions of limbs. The studies found that vascular remodelling and other means still cannot alleviate the symptoms of ischemia. The amputation rate is 10%–40%, and the mortality rate is up to 20% in patients with CLI within six months. The angiogenesis is the optimal treatment for CLI, and autologous stem cell therapy is an emerging alternative treatment.