Last updated on September 2007

Hematopoietic Stem Cell Therapy in Chronic Wounds Using a Pressure Sore Model

Brief description of study

Aim of the study: Evaluation of feasibility, safety and potential effects of stem cells on chronic wounds using a pressure sore model. Clinical relevance: - Accelerated healing of uncomplicated wounds - Enhanced healing of complicated (chronic, non-healing) wounds Study design: - Prospective controlled phase I/II study - Cohort of 5 patients in pilot study, then reevaluation Patients: - Para- and tetraplegic patients with sacral pressure sores grade III-IVA according to the classification of Daniel and Seiler Methods: 1. First surgical intervention: - Radical debridement of pressure sore - Bone marrow harvest from the iliac crest - Isolation of hematopoietic stem cells, aiming to gain > 1 mio. CD 34+ cells per patient under GMP conditions 3. Stem cell therapy (after 2 days) - Injection of stem cells in suspension (50'000 CD 34+ cells in 100 microliter saline per cm2 of wound surface) on one half of the total wound surface and cell-free saline on the other half as a control 4. Second surgical intervention (after 3-4 weeks): - Complete excision of the wound - Closure of the defect by fasciocutaneous flap 5. Evaluation of wound healing: - Clinical - 3D laser imaging - Histology - Growth factor assay

Clinical Study Identifier: NCT00535548

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