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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00535548
• Other study ID #: 552
• Status: Recruiting
• Phase: Phase 1
• First received: September 24, 2007
• Last updated: September 24, 2007
• Start date: January 2007
• Est. completion date: December 2007

Study information

• Verified date: September 2007
• Source: University Hospital, Basel, Switzerland
• Contact: Oliver Scheufler, MD, PhD
• Phone: +41-61-265 2525
• Email: oscheufler[@]gmx.net
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Chronic Wounds
• Hematopoietic Stem Cells
• Pressure Sores
• Pressure Ulcer
• Wound Healing

Intervention

Biological:
• Stem cell therapy
Injection of a hematopoietic stem cell suspension (50'000 CD 34+ cells per microliter) into the wound (1 microliter per cm2 of wound surface)

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Center	Nottwil

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility, safety, efficacy		1 yr