Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 11738 | Registry Identifier | CONEP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Universitário Professor Edgard Santos | OTHER |
| Oswaldo Cruz Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cells in sickle cell disease patients with osteonecrosis
The aim of this study is to evaluate autologous bone marrow stem cells transplantation as a safe and potentially beneficial treatment for sickle cell disease patients with osteonecrosis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous bone marrow stem cell graft | Experimental | Autologous bone marrow stem cell implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous bone marrow stem cell graft | Procedure | All patients will undergo autologous bone marrow stem cell implantation into the necrotic lesion area using a minimally invasive technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional / Clinical Score of 10 points or more | Standardized and objective scoring system to rate patient's functional abilities | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric pain intensity scale (0-10) | VAS scoring system | 60 months |
| Disease progression defined as progression to a fractural stage of osteonecrosis | Radiographic signals |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GIldasio Daltro, MD | Federal University of Bahia | Study Director |
| Vitor Fortuna, PhD | Federal University of Bahia | Principal Investigator |
| Roberto Meyer, MD | Federal University of Bahia | Study Chair |
| Radovan Borojevic, PhD | Federal University of Bahia | Study Chair |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19478932 | Background | Hernigou P, Daltro G, Filippini P, Mukasa MM, Manicom O. Percutaneous implantation of autologous bone marrow osteoprogenitor cells as treatment of bone avascular necrosis related to sickle cell disease. Open Orthop J. 2008 Apr 25;2:62-5. doi: 10.2174/1874325000802010062. | |
| 19885711 | Background | Hernigou P, Daltro G, Flouzat-Lachaniette CH, Roussignol X, Poignard A. Septic arthritis in adults with sickle cell disease often is associated with osteomyelitis or osteonecrosis. Clin Orthop Relat Res. 2010 Jun;468(6):1676-81. doi: 10.1007/s11999-009-1149-3. Epub 2009 Nov 3. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 60 months |
| Reoperation rate | Need for further surgery or hip replacement | 60 months |
| Radiological progression | Radiological progression is defined according to the development of the Ficat- and Steinberg-staging system of osteonecrosis. It is based on radiological findings in X-Ray and MRI scans, respectively, and it is useful in predicting outcomes. | 60 months |
| 27385685 | Background | Hernigou P, Flouzat-Lachaniette CH, Daltro G, Galacteros F. Talar Osteonecrosis Related to Adult Sickle Cell Disease: Natural Evolution from Early to Late Stages. J Bone Joint Surg Am. 2016 Jul 6;98(13):1113-21. doi: 10.2106/JBJS.15.01074. |
| 26021713 | Result | 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. |
| 29788942 | Derived | Daltro G, Franco BA, Faleiro TB, Rosario DAV, Daltro PB, Meyer R, Fortuna V. Use of autologous bone marrow stem cell implantation for osteonecrosis of the knee in sickle cell disease: a preliminary report. BMC Musculoskelet Disord. 2018 May 22;19(1):158. doi: 10.1186/s12891-018-2067-x. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |