Clinical Trials Logo
  1. Home
  2. Chronic Wounds
  3. NCT00535548

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

Wound Healing Clinical Trial

Official title:
Effect of Hematopoietic Stem Cells in Chronic Wounds Using a Pressure Sore Model: A Pilot Study on Feasibility, Safety and Potential Effects

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00535548
Study type Interventional
Source University Hospital, Basel, Switzerland
Contact Oliver Scheufler, MD, PhD
Phone +41-61-265 2525
Email oscheufler@gmx.net
Status Recruiting
Phase Phase 1
Start date January 2007
Completion date December 2007
View Details
See also
  Status Clinical Trial Phase
Completed NCT05045183 - A Study to Assess Wound Healing Efficacies of Different Clean, Treat, and Protect Wound Care Regimens Compared to Standard of Care and Untreated N/A
Enrolling by invitation NCT04613336 - Efficacy of Topical Heparin Spray on Donor Site Wound Healing Time Compared to Conventional Dressing Among Patients Undergoing Split Thickness Skin Grafting
Recruiting NCT02241811 - Wound Treatment With 3% Sodium Pentaborate Pentahydrate Phase 1
Completed NCT02797899 - Effect of PRF Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft N/A
Completed NCT01227759 - Tyrosur® Gel-Investigation on Wound Healing Efficacy Phase 2
Completed NCT01061502 - Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds Phase 1/Phase 2
Completed NCT00736593 - A Study Evaluating Nexagon™ in the Treatment of Skin Wounds. Phase 1
Completed NCT00977951 - Genomic Changes Associated With the Use of Intradermal Avotermin (Juvista) in Small Wounds in Healthy Male Subjects Phase 1/Phase 2
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT05191082 - Manufacturing, Characterization and Evaluation of the Effect of Silk Fibroin Membranes, Loaded or Not With Neurotensins on Open Wounds in the Palate N/A
Enrolling by invitation NCT05942235 - The Use of Microlearning in Nursing Education
Completed NCT03433820 - Wound Healing in Healthy Volunteers N/A
Withdrawn NCT02383992 - Postoperative Care of Sutured Wounds N/A
Recruiting NCT02034539 - VADOplex Critical Limb Ischemia Study Phase 2/Phase 3
Recruiting NCT01680042 - Clinical Effect of Phenytoin Mucoadhesive Paste on Wound Healing After Oral Biopsy Phase 1
Completed NCT01734317 - An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver. N/A
Withdrawn NCT01008111 - Wound Healing of Incisional Wounds for Bilateral Hernia Repair Phase 1
Completed NCT01115218 - The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy
Completed NCT00984503 - Investigation of the Accelerated Healing and Anti-scarring Potential of Avotermin (Juvista) in Split Skin Graft Donor Sites Phase 2