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| Name | Class |
|---|---|
| Oswaldo Cruz Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Conventional treatment established by the good clinical practice Patients received standard local care dressing method (compresses) to heal leg ulcers | |
| Stem Cell Injection | Experimental | Intramuscular implantation of Autologous bone marrow-derived mononuclear cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infusion of Autologous Bone Marrow Mononuclear Cells | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| 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 | 6 months to one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months to one year |
| Ulcer Healing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Valber Meneses, MD | Federal University of Bahia | Study Chair |
| Gildasio Daltro, MD | Federal University of Bahia | Study Director |
| Vitor A Fortuna, PhD | Federal University of Bahia | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26021713 | Background | 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. |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area Ulcer diameter will be recorded
| 6 months to one year |
| Quality of Life | Change in quality of life as well as other indicators of patient comfort and well-being | 6 months to one year |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |