Progenitor cell therapy for sacral pressure sore: a pilot study with a novel human chronic wound model.

INTRODUCTION: Chronic wounds are a major health-care issue, but research is limited by the complexity and heterogeneity in terms of wound etiology as well as patient-related factors. A suitable animal model that replicates the situation in humans is not available. Therefore, the aim of the present work is to present a standardized human wound model and the data of a pilot study of topically applied progenitor cells in a sacral pressure sore. METHODS: Three patients underwent cell harvest from the iliac crest at the time of the initial debridement. Forty-eight hours after bone marrow harvest and debridement, the CD34+ selected cell suspension was injected into the wound. With the aid of a laser scanner, three-dimensional analyses of wound morphometry were performed until the defect was reconstructed with a local flap 3 weeks after debridement. RESULTS: Decreases in volume to 60%±6% of baseline on the sham side and to 52%±3% of baseline on the cell side were measured. Histologic work-up revealed no signs of metaplastic, dysplastic, or neoplastic proliferation/differentiation after progenitor cell treatment. CD34+ cells were detected in the biopsies of day 0. CONCLUSIONS: The pressure sore wound model allows investigation of the initial 3 weeks after cell-based therapy. Objective outcome analysis in terms of wound volume and histology can be performed without, or with, minimal additional morbidity, and the anatomy of the sacral area allows a control and study side in the same patient. Therefore, this model can serve as a standard for wound-healing studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT00535548.