Wound Healing Clinical Trial
Official title:
Effect of Hematopoietic Stem Cells in Chronic Wounds Using a Pressure Sore Model: A Pilot Study on Feasibility, Safety and Potential Effects
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
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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