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

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
  2. 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
  3. Second surgical intervention (after 3-4 weeks):
    • Complete excision of the wound
    • Closure of the defect by fasciocutaneous flap
  4. Evaluation of wound healing:
    • Clinical
    • 3D laser imaging
    • Histology
  5. Growth factor assay
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