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

NCT00535548 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2007-09-26

No results posted yet for this study

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

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Oliver Scheufler, MD, PhD · University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Completion
2007-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00535548 on ClinicalTrials.gov