Autologous Bone Marrow Stem Cell Transplantation for Osteonecrosis in Sickle Cell Disease
NCT ID: NCT02448121
Last Updated: 2017-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2006-08-31
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autologous bone marrow stem cell graft
Autologous bone marrow stem cell implantation
Autologous bone marrow stem cell graft
All patients will undergo autologous bone marrow stem cell implantation into the necrotic lesion area using a minimally invasive technique.
Interventions
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Autologous bone marrow stem cell graft
All patients will undergo autologous bone marrow stem cell implantation into the necrotic lesion area using a minimally invasive technique.
Eligibility Criteria
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Inclusion Criteria
* FICAT classification of osteonecrosis, inclusive of Stage II.
* Diagnosis will be based on X-Ray and magnetic resonance imaging (MRI).
* No infection in affected bones at the time of surgery.
* Patient competent to give informed consent.
* Scoring at least 20 points on the pain and daily life activities questionnaire.
Exclusion Criteria
* Patients with a history of corticosteroids or on active therapy
* Bone infection at the limb affected by necrosis
* 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 osteonecrosis of the femoral head
18 Years
55 Years
ALL
No
Sponsors
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Hospital Universitário Professor Edgard Santos
OTHER
Oswaldo Cruz Foundation
OTHER
Federal University of Bahia
OTHER
Responsible Party
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Vitor Fortuna
PhD
Principal Investigators
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GIldasio Daltro, MD
Role: STUDY_DIRECTOR
Federal University of Bahia
Vitor Fortuna, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Bahia
Roberto Meyer, MD
Role: STUDY_CHAIR
Federal University of Bahia
Radovan Borojevic, PhD
Role: STUDY_CHAIR
Federal University of Bahia
References
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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.
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.
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.
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.
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.
Other Identifiers
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11738
Identifier Type: REGISTRY
Identifier Source: secondary_id
CAAE 25000039812/2005-99
Identifier Type: -
Identifier Source: org_study_id