Autologous bone marrow mononuclear cell implantation therapy is an effective limb salvage strategy for patients with severe peripheral arterial disease

Abstract

Objective: This study was conducted to determine if intramuscular and intra-arterial stem cell injections delay or prevent major limb amputations, improve ankle-brachial index measurements, relieve rest pain, and improve ulcer healing.

Methods: A prospective case series with interventions occurring between December 2007 and September 2012 and a 3-month minimum follow-up was conducted at an urban tertiary care referral hospital. Patients with severe limb-threatening peripheral arterial disease, without other options for revascularization, were eligible for enrollment. Dual intramuscular and intra-arterial injection of bone marrow mononuclear cells harvested from the iliac crest was performed. Major limb amputation at 3 months was the primary outcome measure. Secondary outcome measures included ankle-brachial index measurements, rest pain, and ulceration healing. Kaplan-Meier survivorship was performed to ascertain overall survivorship of the procedure.

Results: No complications related to the procedure were reported. Of 49 patients (56 limbs) enrolled, two patients (two limbs) died, but had not undergone major amputation, and five limbs (8.9%) underwent major amputation within the first 3 months. Three-month follow-up evaluations were conducted on the remaining 49 limbs (42 patients). Median postprocedure revised Rutherford and Fontaine classifications were significantly lower compared with median baseline classifications. After 3 months, seven patients (nine limbs) died but had not undergone major amputation, and seven limbs (14.3%) underwent major amputation. At a mean follow-up of 18.2 months, the remaining 33 limbs (29 patients) had not undergone a major amputation. Freedom from major adverse limb events (MALE) was 91.1% (95% confidence interval, 79.9-96.2) at 3 months and 75.6% (95% confidence interval, 59.4-86.1) at 12 months.

Conclusions: This procedure was designed to improve limb perfusion in an effort to salvage limbs in patients for whom amputation was the only viable treatment option. The results of this analysis indicate that it is an effective strategy for limb salvage for patients with severe peripheral arterial disease.

Trial registration: ClinicalTrials.gov NCT00919516.

Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.