No effective blood-flow enhancement
therapies are available for patients with severe
peripheral arterial disease (
SPAD), thus
amputation remains the only option for relief of rest
pain or
gangrene. Autologous bone marrow-derived stem cell
therapy (ABMSCT) is an emerging modality to induce angiogenesis from endothelial progenitors. A total of 5 patients with
SPAD were treated by ABMSCT using isolated CD34+ cells with characterized phenotype administered by
intramuscular injections. The follow-up before and 1, 3, 6, 9, and 12 months after ABMSCT was based on clinical (rest
pain, walking distance without
pain, nonhealing
ulcers, ankle-brachial index [ABI]) and laboratory (angiography, duplex and
laser ultrasonography, TcPO(2)) parameters. Significant improvement of
pain and walking distance was observed in all patients. Nonhealing
ulcers disappeared in 3 patients and became smaller and thinner in 1 patient. The average of ABI improved significantly on the treated limb but did not change on the contralateral limb. New collaterals were detected by angiography in 3 patients, but duplex ultrasonography detected improvement in one patient only.
Laser ultrasonography showed a mild significant change, TcPO(2) values improved mainly on the foot. Severe adverse events were not observed. We conclude that ABMSCT with isolated CD34+ cells is safe, effective, and results in sustained clinical benefit for patients with
SPAD.