Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment
|ClinicalTrials.gov Identifier: NCT01572376|
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : August 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type IV Pressure Ulcers Chronic Wounds Spinal Cord Injury||Procedure: Infusion of autologous bone marrow stem cells after wound debridement.||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treatment of Pressure Ulcers With Autologous Bone Marrow Stem Cells in Spinal Cord Injury Patients.Phase I/II Study.|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2010|
Experimental: Bone marrow stem cells
Bone marrow was obtained by posterosuperior iliac crest aspiration under topical anesthesia. Mononuclear cells were isolated by Ficoll density gradient and will be resuspended in heparinized isotonic saline for infusion into the wound.
Procedure: Infusion of autologous bone marrow stem cells after wound debridement.
Cleaning of the wound with heparinized saline, cell infusion and closing with suture.
- Absence of adverse effects during timeframe as infections or complications related with the intervention. [ Time Frame: Six months ]The proposed trial will involve the recruitment of a total of 30 patients. The cells will be collected via bone marrow sampling. The aspirate will centrifuged on a Ficoll density gradient to isolate mononuclear cells, wich will be resuspended in heparinized isotonic saline for infusion into the area of the wound. Assessment of adverse events will be by wound examination and laboratory (microbiological)parameters
- Improvement and closure of the pressure ulcer [ Time Frame: One year ]The closure of the ulcer will be assessed by NMR and physical examination
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572376
|Hospital Universitario Central de Asturias|
|Oviedo, Asturias, Spain, 33006|