Back to resultsAutologous Bone Marrow Stem Cells for Chronic Leg Ulcer Treatment in Sickle Cell Disease
Primary Purpose
Chronic Leg Ulcer, Sickle Cell Disease
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Infusion of Autologous Bone Marrow Mononuclear Cells
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Leg Ulcer focused on measuring Cell Therapy, Sickle cell disease, Autologous implantation, Mesenchymal stromal cell, Edothelial Progenitor cell
Eligibility Criteria
Inclusion Criteria:
- Stable sickle cell disease patients
- Patient hospitalized into the dermatology unit
- Patient with an evolutive leg ulcer since more than 1 year
- No infection at the time of surgery
- Patient competent to give informed consent
Exclusion Criteria:
- Patients with a history of corticosteroids or on active therapy
- infection at the limb affected by ulcer
- Recurrent painful crises,
- Immunosuppressive drug therapy,
- Pregnancy,
- Presence of neoplastic disease or any other clinical concurrent condition other than sickle cell disease that predisposed them to the development of leg ulcer
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Stem Cell Injection
Arm Description
Conventional treatment established by the good clinical practice Patients received standard local care dressing method (compresses) to heal leg ulcers
Intramuscular implantation of Autologous bone marrow-derived mononuclear cells
Outcomes
Primary Outcome Measures
Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Change in Leg Ulcer
Rate and extent of leg ulcer wound healing as measured by change in wound surface area Ulcer diameter will be recorded
Secondary Outcome Measures
Numeric pain intensity scale (0-10)
Change in Sickle Cell Disease leg ulcer wound pain scores as measured by a 10-point scale (analogic visual scale) and relative to non-wound site pain scores
Ulcer Healing
Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area Ulcer diameter will be recorded
Quality of Life
Change in quality of life as well as other indicators of patient comfort and well-being
Full Information
NCT ID
NCT02619734
First Posted
November 30, 2015
Last Updated
December 1, 2015
Sponsor
Federal University of Bahia
Collaborators
Oswaldo Cruz Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02619734
Brief Title
Autologous Bone Marrow Stem Cells for Chronic Leg Ulcer Treatment in Sickle Cell Disease
Official Title
Efficacy and Safety of Autologous Bone Marrow Stem Cells Infusion for Treatment of Chronic Leg Ulcer in Sickle Cell Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia
Collaborators
Oswaldo Cruz Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cell implantation for the treatment of leg ulcer in adult patients with sickle cell disease.
Detailed Description
Implantation of bone marrow mononuclear cells, including endothelial progenitor cells and mesenchymal stromal cells, into leg ulcers has been shown to improve wound healing.
In the present study the safety and efficacy of autologous bone marrow mononuclear cells implantation will be investigated in patients with chronic leg ulcers. Forty cases will be enrolled. Improvement in the pain, rate and extent of leg ulcer wound healing as measured by change in wound surface area will be evaluated until one year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Leg Ulcer, Sickle Cell Disease
Keywords
Cell Therapy, Sickle cell disease, Autologous implantation, Mesenchymal stromal cell, Edothelial Progenitor cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Conventional treatment established by the good clinical practice Patients received standard local care dressing method (compresses) to heal leg ulcers
Arm Title
Stem Cell Injection
Arm Type
Experimental
Arm Description
Intramuscular implantation of Autologous bone marrow-derived mononuclear cells
Intervention Type
Biological
Intervention Name(s)
Infusion of Autologous Bone Marrow Mononuclear Cells
Intervention Description
Autologous bone marrow-derived mononuclear cells will be administered by intramuscular injection into and around the leg ulcer. The number of injected cells will be from 5x108 to 1x109 total number of cells on Study Day 1.
Primary Outcome Measure Information:
Title
Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Description
Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Time Frame
6 months
Title
Change in Leg Ulcer
Description
Rate and extent of leg ulcer wound healing as measured by change in wound surface area Ulcer diameter will be recorded
Time Frame
6 months to one year
Secondary Outcome Measure Information:
Title
Numeric pain intensity scale (0-10)
Description
Change in Sickle Cell Disease leg ulcer wound pain scores as measured by a 10-point scale (analogic visual scale) and relative to non-wound site pain scores
Time Frame
6 months to one year
Title
Ulcer Healing
Description
Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area Ulcer diameter will be recorded
Time Frame
6 months to one year
Title
Quality of Life
Description
Change in quality of life as well as other indicators of patient comfort and well-being
Time Frame
6 months to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable sickle cell disease patients
Patient hospitalized into the dermatology unit
Patient with an evolutive leg ulcer since more than 1 year
No infection at the time of surgery
Patient competent to give informed consent
Exclusion Criteria:
Patients with a history of corticosteroids or on active therapy
infection at the limb affected by ulcer
Recurrent painful crises,
Immunosuppressive drug therapy,
Pregnancy,
Presence of neoplastic disease or any other clinical concurrent condition other than sickle cell disease that predisposed them to the development of leg ulcer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Valber Meneses, MD
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gildasio Daltro, MD
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vitor A Fortuna, PhD
Organizational Affiliation
Federal University of Bahia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26021713
Citation
Daltro GC, Fortuna V, de Souza ES, Salles MM, Carreira AC, Meyer R, Freire SM, Borojevic R. Efficacy of autologous stem cell-based therapy for osteonecrosis of the femoral head in sickle cell disease: a five-year follow-up study. Stem Cell Res Ther. 2015 May 29;6(1):110. doi: 10.1186/s13287-015-0105-2.
Results Reference
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Autologous Bone Marrow Stem Cells for Chronic Leg Ulcer Treatment in Sickle Cell Disease
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