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

September 24, 2007 updated by: University Hospital, Basel, Switzerland

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Nottwil, Switzerland, 6207
        • Recruiting
        • Swiss Paraplegic Center
        • Sub-Investigator:
          • Zweifel-Schlatter Mirjam, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
feasibility, safety, efficacy
Time Frame: 1 yr
1 yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Study Director: Oliver Scheufler, MD, PhD, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (Anticipated)

December 1, 2007

Study Registration Dates

First Submitted

September 24, 2007

First Submitted That Met QC Criteria

September 24, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

September 26, 2007

Last Update Submitted That Met QC Criteria

September 24, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 552

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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