Transplantation of purified CD34 + cells from peripheral blood in the treatment of critical ischemia of the lower extremities

Abstract

Objective To evaluate the safety, feasibility and efficacy of transplantation of purified peripheral blood CD34+ cells in treatment of critical ischemia of the lower extremities. Methods From May 2009 to March 2010, seven cases of critical ischemia of the lower extremities received purified peripheral blood CD34+ cells transplantation, among those 6 were caused by thromboangiitis obliterans and 1 by thrombosis coexistent with nodular erythema. Mean age was ( 39 ± 11 ) years ( range 23 - 54 ), and all patients were not suitable for surgical or endovascular revascularization. G-CSF was subcutaneously injected for 5 days before apheresis for peripheral blood mononuclear cells. Then CliniMACS system was used to isolate the CD34+ cells. If the number of CD34+ cells was between 105/kg and 106/kg , they were all intramuscular injected into patients' calf and foot. Results Technical success and limb salvage were achieved in all cases. The mean number of transplanted cells was (7. 1 ±2.3) × 105/kg [ range(4.6 ×105 -1 × 106 )/kg]. All cases were followed-up, ranging from 6 - 14 months (mean 8 ± 3 months). One month after transplantation, the rest pain was obviously relieved in all cases, and the Wong-Baker FACES pain rating scale score significantly decreased from 7. 1 ±2. 0(4 - 10)to 1. 1 ± 1.1 (0 -2) ,P =0. 0000. The pain-free walking distance was significantly improved from (4 ± 4) min (range 1 -10 min)to (12 ± 7 ) min (range 5 - 21min , P =0.04) at 3 months and(20.4 ± 12.5) min(range 6 -40 min, P = 0.02) at 6 months, respectively. The ankle-brachial index increased from 0. 54 ± 0. 18 ( range 0. 41 - 0. 87 ) to 0.66 ±0. 13(range 0. 52-0. 86 , P=0. 17)at 3 months and 0.72 ±0. 13(range 0.56 -0.91, P=0. 07)at 6 months, respectively. Of 6 cases with the toe ulcer, the ulcer was healed in 3 and apparently shrank in 3. Transcutaneous partial oxygen pressure rose from (29 ± 14) mm Hg(range 10 -52 mm Hg)to 46 ±14 mm Hg ( range 27 - 63 mm Hg, P = 0. 04) at 3 months and (57 ± 10) mm Hg( range 41 - 66 mm Hg, P =0.001) at 6 months, respectively. No serious complications were found either perioperatively or postoperatively. Conclusions Transplantation of purified peripheral blood CD34+ cells is safe, feasible and effective in the treatment of critical ischemia of the lower extremities. Key words: Thromboangiitis obliterans; Cell transplantation; Ischemia of lower extremities; Antigens, CD34