Autologous Bone Marrow Stem Cell Transplantation for Osteonecrosis in Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT02448121|
Recruitment Status : Unknown
Verified November 2017 by Vitor Fortuna, Federal University of Bahia.
Recruitment status was: Active, not recruiting
First Posted : May 19, 2015
Last Update Posted : November 20, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Avascular Necrosis of Bone Sickle Cell Disease||Procedure: Autologous bone marrow stem cell graft||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment for Hip, Knee, Ankle and Shoulder Osteonecrosis With Autologous Mononuclear Cells Transplantation in People With Sickle Cell Disease|
|Study Start Date :||August 2006|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: Autologous bone marrow stem cell graft
Autologous bone marrow stem cell implantation
Procedure: 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.
- Change in Functional / Clinical Score of 10 points or more [ Time Frame: 60 months ]Standardized and objective scoring system to rate patient's functional abilities
- Numeric pain intensity scale (0-10) [ Time Frame: 60 months ]VAS scoring system
- Disease progression defined as progression to a fractural stage of osteonecrosis [ Time Frame: 60 months ]Radiographic signals
- Reoperation rate [ Time Frame: 60 months ]Need for further surgery or hip replacement
- Radiological progression [ Time Frame: 60 months ]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.
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Stable sickle cell disease patients
- 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.
- FICAT stage III or more
- Patients with a history of corticosteroids or on active therapy
- Bone infection at the limb affected by necrosis
- Recurrent painful crises,
- Immunosuppressive drug therapy,
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448121
|Study Director:||GIldasio Daltro, MD||Federal University of Bahia|
|Principal Investigator:||Vitor Fortuna, PhD||Federal University of Bahia|
|Study Chair:||Roberto Meyer, MD||Federal University of Bahia|
|Study Chair:||Radovan Borojevic, PhD||Federal University of Bahia|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Vitor Fortuna, PhD, Federal University of Bahia|
|Other Study ID Numbers:||
11738 ( Registry Identifier: CONEP )
|First Posted:||May 19, 2015 Key Record Dates|
|Last Update Posted:||November 20, 2017|
|Last Verified:||November 2017|
Sickle cell disease
Mesenchymal stromal cell
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn