NCT00535548

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2007-01-01
• Completion: 2007-12-01
• First posted: 2007-09-26
• Last updated: 2007-09-26

Locations

1 site across 1 country: Switzerland