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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by University Hospital, Basel, Switzerland.
Recruitment status was:  Recruiting
Information provided by:
University Hospital, Basel, Switzerland Identifier:
First received: September 24, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted

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


- Para- and tetraplegic patients with sacral pressure sores grade III-IVA according to the classification of Daniel and Seiler


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: Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
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:

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)

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00535548

Contact: Oliver Scheufler, MD, PhD +41-61-265 2525

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00535548     History of Changes
Other Study ID Numbers: 552
Study First Received: September 24, 2007
Last Updated: September 24, 2007

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

Additional relevant MeSH terms:
Wounds and Injuries
Pressure Ulcer
Skin Ulcer
Skin Diseases processed this record on April 25, 2017