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February 11, 2010—Grant Medical Center in Columbus, Ohio announced that results of a clinical trial documenting the outcomes of nine patients who received transplants of adult stem cells were published by Randall W. Franz, MD, et al in the Journal of Vascular Surgery (2009;50:1378–1390). Few options other than amputation exist for some patients with peripheral arterial disease (PAD) and severe anatomical limitations, the investigators noted.

In this prospective study, the investigators presented short-term results of dual-intramuscular and intra-arterial autologous bone marrow mononuclear cell (BM-MNC) implantation for treating patients with severe PAD for whom amputation was considered the only viable treatment option. Baseline 2-week and 3-month evaluations were conducted. Ankle-brachial indices (ABI) were calculated for both the dorsalis pedis and posterior tibial arteries. Rest pain and ulcer healing also were assessed. Success was defined as meeting the following four criteria: (1) improvement in ABI measurements, (2) relief of rest pain, (3) ulcer healing, if applicable, and (4) absence of major limb amputations. Patients not undergoing major limb amputations continued to be monitored for subsequent procedures.

As detailed in the Journal of Vascular Surgery, the study was composed of nine patients for whom limb amputation was originally recommended and underwent this procedure. The study population was composed of five women and four men, with a mean age of 61.7 years. Eight patients (88.9%) had rest pain, seven patients (77.8%) had diabetes, and non-healing ulcers were present in eight cases (88.9%).

The investigators reported that after the procedure, nonsignificant improvements of 0.12 and 0.08 in ABI were observed for the dorsalis pedis and posterior tibial ankle arteries, respectively. Three major amputations (33.3%) were subsequently performed, including a below-the-knee amputation 4.1 weeks after the BM-MNC implantation and two above-the-knee amputations performed at 5.4 and 11 weeks after the procedure. The six patients (66.7%) who did not have major amputations demonstrated improvement in symptom severity 3 months after the procedure, as evidenced by the alleviation of rest pain and improvements by at least one level in Rutherford and Fontaine classifications, and they have not required amputations at a mean follow-up of 7.8 months. Complete wound healing was achieved within 3 months in all patients who had ulcers before BM-MNC implantation and for whom amputation was not required. This specific BM-MNC implantation technique was fully successful in three patients (33.3%) because major amputation was avoided and the other applicable criteria were met. Five additional patients (55.6%) demonstrated success in at least one of the four criteria.

The investigators concluded that with eight of nine patients (88.9%) showing some level of improvement and amputation avoided in six patients (66.7%), these short-term results indicate the use of BM-MNC implantation as a means of limb salvage therapy for patients with severe PAD and shows promise in postponing or avoiding amputation in a patient population that is currently presented with few alternatives to amputation.

According to the medical center, Grant surgeons extracted specialized stem cells from the patient’s hip, separated them by centrifuge, and injected them into the arteries and muscles at the site of the blockage. The investigators found that uncultured cells still in their natural environment worked better than cultured cells because the uncultured cells contain growth factors and other cellular elements necessary for the formation and growth of new blood vessels. The minimally invasive percutaneous procedures typically took less than an hour and required overnight hospital stays.

"We were pleasantly surprised by our results," commented Dr. Franz, who is Medical Director of the Grant Vascular and Vein Center. "A total of 16 patients have now received the procedure, with 13 patients avoiding major amputation. This is cutting-edge technology that could benefit millions of Americans with PAD."

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