Use of autologous bone marrow mononuclear cell implantation therapy as a limb salvage procedure in patients with severe peripheral arterial disease.

BACKGROUND: Few options other than amputation exist for some patients with peripheral arterial occlusive disease (PAD) and severe anatomical limitations.
METHODS: This prospective study presents short-term results of dual intramuscular and intra-arterial autologous bone marrow mononuclear cell (BM-MNC) implantation for the treatment of patients with severe PAD in whom amputation was considered the only viable treatment option. Baseline, two-week, and three-month evaluations were conducted. Ankle brachial indices (ABI) were calculated for both the dorsal pedis and the posterior tibial arteries. Rest pain and ulcer healing also were assessed. Success was defined as meeting the following four criteria: improvement in ABI measurements; relief of rest pain; ulcer healing, if applicable; and absence of major limb amputations. Patients not undergoing major limb amputations continued to be monitored for subsequent procedures.
RESULTS: Nine patients for whom limb amputation was recommended underwent this procedure. The study population was comprised of five females and four males, with a mean age of 61.7 years. Eight (88.9%) patients had rest pain. Seven (77.8%) patients also had diabetes. Non-healing ulcers were present in eight (88.9%) cases. After the procedure, non-significant improvements of 0.12 and 0.08 in ABI were observed for the dorsalis pedis and posterior tibial ankle arteries, respectively. Three (33.3%) major amputations subsequently were performed, including a below-knee amputation 4.1 weeks after the BM-MNC implantation and two above-knee amputations at 5.4 and 11.0 weeks after the procedure. The six (66.7%) patients who did not have major amputations demonstrated improvement in symptom severity three months after the procedure, as evidenced by alleviation of rest pain and improvements by at least one level in Rutherford and Fontaine classifications, and have not required amputations at a mean follow-up of 7.8 months. Complete wound healing was achieved within three months in all patients who had ulcers prior to BM-MNC implantation and for whom amputation was not required. This specific BM-MNC implantation technique was fully successful in three (33.3%) patients, as major amputation was avoided and the other applicable criteria were met. Five (55.6%) additional patients demonstrated success in at least one of the four criteria.
CONCLUSIONS: With eight (88.9%) of nine patients showing some level of improvement and amputation avoided in six (66.7%) patients, these short-term results indicate the use of BM-MNC implantation as a means of limb salvage therapy for patients with severe PAD shows promise in postponing or avoiding amputation in a patient population currently presented with few alternatives to amputation.