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Clinical Trial Summary

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 Trial Description

n/a


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT00535548
Study type Interventional
Source University Hospital, Basel, Switzerland
Contact Oliver Scheufler, MD, PhD
Phone +41-61-265 2525
Email oscheufler@gmx.net
Status Recruiting
Phase Phase 1
Start date January 2007
Completion date December 2007

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