Autologous stem cell-based therapy for sickle cell leg ulcer: a pilot study.
Recurrent chronic leg ulcers are among the most severe vasculopathic complications of sickle cell disease (SCD). Their treatment remains a challenge. Stem cell therapy with bone marrow mononuclear cells (BMMC) is a promising new therapeutic option for other forms of chronic ulcers. This prospective pilot study was performed to evaluate safety and feasibility of BMMC implantation in patients with SCD and chronic leg ulcers (SCLU). Ulcer closure, recurrence and local pain were evaluated. BMMC were successfully administered to 23 SCLU patients and no serious adverse events occurred. During the 6-month follow-up period, 91·3% of patients had improved ulcer pain compared with baseline and 29·2% of the treated ulcers achieved total healing. The frequency of progenitor stem cells (CD34CD45lowand fibroblast colony-forming units) in BMMC was found to be significantly reduced in SCLU patients and compared to SCD patients without ulcers (P < 0·004 and P < 0·01, respectively). No relationship was observed between treatment outcome and the number of implanted BM progenitor stem cells. In conclusion, BMMC implantation is a feasible and safe procedure, showing favourable outcomes for the treatment of SCLU, and encouraging further controlled clinical trials.
Prof. Edgar Santos Hospital Complex, Salvador, BA, Brazil.
José Válber L
JV
Meneses
Health Science Institute, Federal University of Bahia, Salvador, BA, Brazil.
Vitor
V
Fortuna
Health Science Institute, Federal University of Bahia, Salvador, BA, Brazil.
Eliane Silva
ES
de Souza
Prof. Edgar Santos Hospital Complex, Salvador, BA, Brazil.
Gildasio Cerqueira
GC
Daltro
Health Science Institute, Federal University of Bahia, Salvador, BA, Brazil.
Roberto
R
Meyer
Division of Hematology-Oncology, Department of Medicine, Montefiore Medical Center, Bronx, NY, USA.
Caterina P
CP
Minniti
Petrópolis School of Medicine/Arthur de Sá Earp Faculties, Petrópolis, RJ, Brazil.
Radovan
R
Borojevic
D000293:Adolescent; D000328:Adult; D000755:Anemia, Sickle Cell / Q000150:complications; D001854:Bone Marrow Cells / Q000166:cytology; D005260:Female; D006801:Humans; D007871:Leg Ulcer / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009000:Monocytes / Q000166:cytology; D010865:Pilot Projects; D011446:Prospective Studies; D033581:Stem Cell Transplantation / Q000379:methods*; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014945:Wound Healing; D055815:Young Adult
bone marrow; clinical trial; leg ulcer; sickle cell disease; stem cell transplantation