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Abstract Our study was done in Ain Shams University Hospitals over a period of 3 years from May 2007 to May 2010. It was a randomized controlled study including 40 patients divided equally and randomized into 2 groups as follow: Group I: Intervention group was treated by stem cell therapy combined with prostavasin therapy for 21 days. Group II: Controlled group treated only with prostavasin therapy for 21 days. Among the 40 patients included in this 9 patients had atherosclerosis and 31 patients proved to arteritis. Among the 40 patients there was higher male incidence (77.5%), the male to female ratio is 3:1. The age distribution reflects higher prevalence in the age group 40-60yrs, (70%) followed by those 30-40yrs (30%) the youngest patient was 33yrs old male and the oldest patient was 74yrs old male. The main associated co-morbidities in the in-cluded patients were 9 patients (22.5%) with diabetes mellitus and 18 patients (45%) with hypertension. All patients in this study were complaining from CLI (rest pain in 8 patients, crippling claudication in 4 patients, tissue loss in 28 patients). The BM-MNCs were obtained by aspiration of 240ml of bone marrow from one or both iliac crests under deep sedation. The aspirate of 300-500ml of bone marrow gave a concentrate volume of about 30-50ml of BM-MNCs. The route of administration of stem cells was by intramuscular injection in the muscles of the ischemic limb. According to the level of the occlusion, it was injected in the calf muscles in the infra-poilateal disease (29 patients) and in calf muscles and quadriceps muscles for femero-politeal disease and aorto-iliac disease (11 patients). The patient population showed improvement of symptoms; regarding rest pain, out of 4 patients in the intervention group 3 patients (75%) showed marked improvement and 1 patient did not improve (25%). On the other hand, in the control group out of 4 patients, 2 patients (50%) showed improvement and the other 2 patients (50%) did not improve. Regarding tissue loss out of 12 patients in the intervention group, 8 patients improved (66%) and 4 patients (34%) did not improve. On the other hand, in the control group out of 16 patients presented with tissue loss 12 patients improved (75%) and 4 patients did not improve (25%). Regarding crippling claudication which is examined using treadmill in the intervention group out of 4 patients all of them improved. As regards the ABI in the intervention group out of 15 patients, 12 patients (80%) showed improvement of the ABI while 3 patients (20%) showed no change in the ABI. On the other hand in the control group out of 14 patients, 10 patients (71%) showed improvement in the ABI, while 4 patients (29%) showed no change in ABI. In the current study, 5 patients (25%) failed to respond to stem cell therapy with spreading gangrene or life threatening infection of their legs and they were scheduled for major amputation, 1 patient underwent amputation and the other 4 patients refused to do amputation. Finally, it can be concluded that stem cell therapy is a rising hope for patients with PAD. It worths trial in all patients with CLI with good results in early CLI and less favorable results in delayed stages of CLI. |