Ignite Creation Date:
2024-05-05 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00535548
Status:
UNKNOWN
Last Update Posted:
2007-09-26
First Post:
2007-09-24
Brief Title:
Hematopoietic Stem Cell Therapy in Chronic Wounds Using a Pressure Sore Model
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Effect of Hematopoietic Stem Cells in Chronic Wounds Using a Pressure Sore Model A Pilot Study on Feasibility Safety and Potential Effects
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 III 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 50000 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
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 III 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 50000 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None