Back to resultsAutologous Bone Marrow Stem Cells in Pressure Ulcer Treatment
Primary Purpose
Type IV Pressure Ulcers, Chronic Wounds, Spinal Cord Injury
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Infusion of autologous bone marrow stem cells after wound debridement.
Sponsored by
About this trial
This is an interventional treatment trial for Type IV Pressure Ulcers focused on measuring Pressure ulcers, Chronic wounds, Spinal cord injury patients, Bone marrow, Mononuclear, Debridement
Eligibility Criteria
Inclusion Criteria:
- Type IV ulcer pressures of more than 4 months topical treatment without response
- No option for conventional surgery
- Age range of 18-75 years old
Exclusion Criteria:
- Patients out of inclusion age range
- Patients with evidences of mental illness
- Patients with evidences of previous alcohol or drugs dependencies
- Pregnant women
- Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma
Sites / Locations
- Hospital Universitario Central de Asturias
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bone marrow stem cells
Arm Description
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.
Outcomes
Primary Outcome Measures
Absence of adverse effects during timeframe as infections or complications related with the intervention.
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
Secondary Outcome Measures
Improvement and closure of the pressure ulcer
The closure of the ulcer will be assessed by NMR and physical examination
Full Information
NCT ID
NCT01572376
First Posted
March 28, 2012
Last Updated
August 24, 2015
Sponsor
Hospital Universitario Central de Asturias
1. Study Identification
Unique Protocol Identification Number
NCT01572376
Brief Title
Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment
Official Title
Treatment of Pressure Ulcers With Autologous Bone Marrow Stem Cells in Spinal Cord Injury Patients.Phase I/II Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario Central de Asturias
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to determine the safety and feasibility of an autologous mononuclear stem cells infusion in pressure ulcers of paraplegic patients; and moreover, to evaluate the efficacy of the treatment.
Detailed Description
Taking into account the encouraging results obtained in the treatment of non-healing chronic wounds using bone marrow cells Given that treatment strategies for pressure ulcers can be both costly and complex, in this study we examine the possibility of improving pressure ulcer healing using stem cell therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type IV Pressure Ulcers, Chronic Wounds, Spinal Cord Injury
Keywords
Pressure ulcers, Chronic wounds, Spinal cord injury patients, Bone marrow, Mononuclear, Debridement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bone marrow stem cells
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Infusion of autologous bone marrow stem cells after wound debridement.
Intervention Description
Cleaning of the wound with heparinized saline, cell infusion and closing with suture.
Primary Outcome Measure Information:
Title
Absence of adverse effects during timeframe as infections or complications related with the intervention.
Description
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
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Improvement and closure of the pressure ulcer
Description
The closure of the ulcer will be assessed by NMR and physical examination
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type IV ulcer pressures of more than 4 months topical treatment without response
No option for conventional surgery
Age range of 18-75 years old
Exclusion Criteria:
Patients out of inclusion age range
Patients with evidences of mental illness
Patients with evidences of previous alcohol or drugs dependencies
Pregnant women
Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma
Facility Information:
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
21756569
Citation
Sarasua JG, Lopez SP, Viejo MA, Basterrechea MP, Rodriguez AF, Gutierrez AF, Gala JG, Menendez YM, Augusto DE, Arias AP, Hernandez JO. Treatment of pressure ulcers with autologous bone marrow nuclear cells in patients with spinal cord injury. J Spinal Cord Med. 2011;34(3):301-7. doi: 10.1179/2045772311Y.0000000010.
Results Reference
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Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment
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