Treatment of non-healing skin ulcers with autologous activated mononuclear cells.

The aim of this study was to investigate whether cultured autologous mononuclear cells (MNC) effectively initiate, accelerate and improve granulation and epithelialisation of skin ulcers. Thirty-three patients with chronic arterial occlusive disease (CAOD; n = 21) or venous post-thrombotic syndrome (PTS; n = 12) were treated with autologous MNC and compared with a control group of 30 patients who received tissue culture medium alone. Previous treatments had been unsuccessful for a mean of 9.23 (3-19) months. MNC were harvested from the peripheral blood of each patient by standard techniques, cultured for three days and applied to the ulcer twice a week. After 4.6 +/- 1.9 weeks, 29/33 ulcers were closed in the MNC group. Patients in the control group took 8.1 +/- 1.2 weeks for 17/30 ulcers. Thus ulcer healing was significantly speedier with MNC seeding; 48% of all ulcers were closed after 30 days of MNC treatment and 92% after 60 days. Patients with PTS responded significantly faster than patients with CAOD. In 90% of patients with painful ulcers MNC treatment resulted in pain relief, whereas in the control group only 50% of patients became pain-free.

RCT Entities:   Population Interventions Outcomes