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

September 24, 2007
September 24, 2007
January 2007
Not Provided
feasibility, safety, efficacy [ Time Frame: 1 yr ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
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Hematopoietic Stem Cell Therapy in Chronic Wounds Using a Pressure Sore Model
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
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
  • Chronic Wounds
  • Pressure Sores
  • Hematopoietic Stem Cells
  • Wound Healing
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)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
December 2007
Not Provided

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
Both
18 Years to 50 Years
No
Contact: Oliver Scheufler, MD, PhD +41-61-265 2525 oscheufler@gmx.net
Switzerland
 
NCT00535548
552
Yes
Not Provided
University Hospital, Basel, Switzerland
Not Provided
Study Director: Oliver Scheufler, MD, PhD University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland
University Hospital, Basel, Switzerland
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP