Autologous Bone Marrow-Derived Stem Cell Therapy in Patients with Severe Peripheral Arterial Disorders: A Pilot Study

• Published in: Blood 2007-11, Vol.110 (11), p.2877-2877
• Main Authors: Boda, Zoltan, Udvardy, Miklos, Razso, Katalin, Szarvas, Mariann, Farkas, Katalin, Toth, Judit, Jambor, Laszlo, Soltesz, Pal, Olah, Zsolt, Ilonczai, Peter, Hunyadi, Janos, Sipos, Tamas, Litauszky, Krisztina, Kappelmayer, Janos, Vereb, Zoltan, Rajnavolgyi, Eva
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V110.11.2877.2877

Introduction. Amputation is the only current option for relief of rest pain or gangrene in patients with severe peripheral arterial disease (SPAD). Up to now, no effective blood-flow enhancement therapies are available. Autologous bone marrow-derived stem cell transplantation (ABMSCT) is an arising therapy modality with an option of building new blood vessels through endothelial stem and/or progenitor cells. Methods. Five patients with SPAD (4 with Buerger's disease and 1 with arteriosclerosis obliterans) were treated by ABMSCT. CD34+/CD133+ cell counts were determined in aspirated bone marrow, CD34+ cells were isolated by magnetic separation and collected into a 10 ml sample. The stem cell suspension was administered by local intramuscular injections (0.5–1.0 ml injections in the musculus gastrocnemius). The follow-up (before; 1−, 3− and 6 months after ABMSCT) based on clinical (rest pain, walking distance without pain, changes of non-healing ulcers, ABI) and laboratory (DS-angiography, Color- and Laser-Doppler scan, TcPO2 measurement and endothel function test) parameters was documented and analyzed. Our goal was to treat the worse limb of all the 5 patients. Results. Therapeutic benefit was shown by complete regression of rest pain in all 5 patients, and by the significant increase of pain-free walking distance (36 m vs. 440 m). Six months after ABMSCT the ischemic ulcers disappeared in 2 patients, and in another 2 patients the large and deep ulcers became smaller and thinner (from 8 cm2 to 2.6 cm2 in one case, and from 30 cm2 to 8 cm2 in another case), and in 1 case no change was realized, where osteomyelitis of the affected toe was diagnosed. The average of ABI improved significantly on the treated lower limb (before: 0.41, 3 and 6 months after: 0.64/0.82). ABI values of the contra-lateral legs did not change. The clinical improvement started 1 months after ABMSCT, it became more prominent after 3 months, and the best clinical results were observed after 6 months of transplantation. Confirmed by post-trial observations obtained at 9 months the clinical improvement was evaluated as stable and long lasting. Using angiography we realized improvement in 3 cases, but only in 1 case using Color-Doppler scan. Before and 6/20 weeks after transplantation the TcPO2 changed on the foot from 18.80/16.78/23.83 mmHg, and on the calf from 36.66/31.25/45.00 mmHg. The laboratory parameters did not show improvement after 1 month, however, after 3 and 6 months improved