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

Phase 1

• Conditions: Chronic Wounds; Pressure Sores; Hematopoietic Stem Cells; Wound Healing

• Registration Number: NCT00535548
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Status Verified: 2007-09
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-24
• Last Update Submitted: 2007-09-24
• Study First Posted: 2007-09-26
• Last Update Posted: 2007-09-26
• Study Completion: 2007-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Para- or tetraplegic
• Sacral pressure sores
• Grade III-IV according to classification of Daniel and Seiler

Exclusion Criteria

• Diabetes mellitus
• Peripheral vascular disease
• Coronary artery disease
• Smoking
• Steroids and other immunosuppressive drugs
• Systemic autoimmune or rheumatoid diseases
• HIV
• Hepatitis B/C

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
feasibility, safety, efficacy	1 yr

Trial Locations

Locations (1)

Swiss Paraplegic Center; 🇨🇭 Nottwil, Switzerland