Chronic Leg Ulcer, Sickle Cell Disease
Conditions
Keywords
Cell Therapy, Sickle cell disease, Autologous implantation, Mesenchymal stromal cell, Edothelial Progenitor cell
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.
Interventions
BIOLOGICALInfusion of Autologous Bone Marrow Mononuclear Cells
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.
Sponsors
Oswaldo Cruz Foundation
Federal University of Bahia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events | 6 months | Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events |
| Change in Leg Ulcer | 6 months to one year | Rate and extent of leg ulcer wound healing as measured by change in wound surface area Ulcer diameter will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric pain intensity scale (0-10) | 6 months to one year | 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 | 6 months to one year | Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area Ulcer diameter will be recorded |
| Quality of Life | 6 months to one year | Change in quality of life as well as other indicators of patient comfort and well-being |
Outcome results
None listed