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

NCT00535548 | Unknown Phase 1 DMC

• 1 other identifier: 552
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic wounds; Pressure sores; Hematopoietic stem cells; Wound healing

Outcome Measures

Primary Outcomes (1)

• feasibility, safety, efficacy

  1 yr

Interventions

Stem cell therapy BIOLOGICAL

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 Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Para- or tetraplegic
• Sacral pressure sores
• Grade III-IV according to classification of Daniel and Seiler

You may not qualify if:

• Diabetes mellitus
• Peripheral vascular disease
• Coronary artery disease
• Smoking
• Steroids and other immunosuppressive drugs
• Systemic autoimmune or rheumatoid diseases
• HIV
• Hepatitis B/C

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Swiss Paraplegic Center

Nottwil, 6207, Switzerland

RECRUITING

Related Publications (1)

• Wettstein R, Savic M, Pierer G, Scheufler O, Haug M, Halter J, Gratwohl A, Baumberger M, Schaefer DJ, Kalbermatten DF. Progenitor cell therapy for sacral pressure sore: a pilot study with a novel human chronic wound model. Stem Cell Res Ther. 2014 Jan 29;5(1):18. doi: 10.1186/scrt407.

  PMID: 24476740 DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Oliver Scheufler, MD, PhD

  University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland

  STUDY DIRECTOR

Central Study Contacts

Oliver Scheufler, MD, PhD

CONTACT

+41-61-265 2525; oscheufler@gmx.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: January 1, 2007
• Study Completion: December 1, 2007
• Last Updated: September 26, 2007

Record last verified: 2007-09

Locations

CH (1)