The effect of autologous bone marrow-derived cells on healing chronic lower extremity wounds: results of a randomized controlled study.

Case studies suggest that bone marrow-derived stem cells may improve chronic wound healing. A prospective, randomized, clinical study was conducted to compare the rate of healing chronic lower limb wounds in patients with diabetes mellitus whose wounds were treated with topically applied and locally injected bone marrow-derived cells or whole blood (control). Of the 48 patients participating in the study, 25 were randomized to study treatment and 23 to control treatment. At baseline, no significant differences were observed between the two groups for patient age (average for treatment group was 54 years, 3 months; range 33 to 76 years and for the control group 58 years, 7 months; range 28 to 69 years), comorbidity (82% in the treatment group and 78% in the control group had diabetes mellitus), ulcer history (mean duration was 14.28 months in the treatment group and 10.21 months in the control group; SD 0.28), or baseline area (mean was 65.32 cm2 in the treatment group and 48.83 cm2 in the control group). After obtaining informed consent, all wounds were surgically debrided. Wounds of study participants randomized to the treatment group were injected and oversprayed with a total of 5 cc of autologous bone marrow-derived cells. Using a similar procedure, the wounds of patients randomized to the control group were injected with 5 cc of autologous peripheral blood. All wounds were covered with saline-moistened gauze and cotton pads. Patients were followed for a maximum of 3 months. The average decrease in wound area at 2 weeks was 17.4% (39.6-43.4 cm2) in the treatment group compared to 4.84% (41.6-42.8 cm2) in the control group. After 12 weeks, the average decrease in wound area was 36.4% (SD 0.48) in the treatment group compared to 27.32% (SD 0.32) in the control group. No adverse events were observed. None of the patients complained of significant pain or discomfort following the procedure, no wound infections occurred, and all patients reported resumption of normal daily activity the day after the procedure. The results of this study show that a single application of autologous bone marrow-derived cells increases the rate of healing chronic lower extremity wounds in the early weeks of treatment. Additional studies to elucidate the treatment mode of action and optimal application frequency as well as comparisons between this and other treatment modalities are warranted.