Bone marrow (BM)-derived mesenchymal stem cells (MSCs) represent a promising population for supporting new concepts in cellular
therapy. This study was undertaken to assess the efficacy and feasibility of autologous BM-derived MSCs in the treatment of chronic nonhealing
ulcers (
diabetic foot ulcers and
Buerger disease) of the lower extremities. A total of 24 patients with nonhealing
ulcers of the lower limb were enrolled and randomized into implant and control groups. In the implant group, the patients received autologous cultured BM-derived MSCs along with standard
wound dressing; the control group received only the standard
wound dressing regimen, followed up for at least a 12-week period.
Wound size,
pain-free walking distance, and biochemical parameters were measured before
therapy and at every 2-week interval following intervention. The implant group had significant improvement in
pain-free walking distance and reduction in
ulcer size as compared to those in the control group. In the implant group for
Buerger disease, the
ulcer area decreased from 5.04 +/- 0.70 cm(2) to 1.48 +/- 0.56 cm(2) (p < 0.001), whereas the
pain-free walking distance increased from 38.33 +/- 17.68 m to 284.44 +/- 212.12 m (p < 0.001). In the
diabetic foot ulcer group, the
ulcer size decreased from 7.26 +/- 1.41 cm(2) to 2 +/- 0.98 cm(2) (p < 0.001) at 12 weeks. Mononuclear cells were cultured for a minimum of five passages and characterized by cell-surface markers showing CD90+, CD105+, and CD34(-). There was no significant alteration in the biochemical parameters observed during the follow-up period, indicating normal liver and renal function following intervention. Biopsy microsection of implanted tissues showed development of dermal cells (mainly fibroblasts), including mature and immature inflammatory cells. The study indicates that autologous implantation of BM-derived MSCs in nonhealing
ulcers accelerates the healing process and improves clinical parameters significantly.