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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by University Hospital, Basel, Switzerland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00535548
First received: September 24, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

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

Condition Intervention Phase
Chronic Wounds
Pressure Sores
Hematopoietic Stem Cells
Wound Healing
 Biological: Stem cell therapy
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effect of Hematopoietic Stem Cells in Chronic Wounds Using a Pressure Sore Model: A Pilot Study on Feasibility, Safety and Potential Effects

Resource links provided by NLM:

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • feasibility, safety, efficacy [ Time Frame: 1 yr ]

Study Start Date: January 2007
Estimated Study Completion Date: December 2007
Intervention Details:
    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)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535548

Contacts
Contact: Oliver Scheufler, MD, PhD +41-61-265 2525 oscheufler@gmx.net

Locations
Switzerland
Swiss Paraplegic Center Recruiting
Nottwil, Switzerland, 6207
Sub-Investigator: Zweifel-Schlatter Mirjam, MD            
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Director: Oliver Scheufler, MD, PhD University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00535548     History of Changes
Other Study ID Numbers: 552
Study First Received: September 24, 2007
Last Updated: September 24, 2007
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Chronic wounds
Pressure sores
Hematopoietic stem cells
Wound healing

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013