Autologous Bone Marrow Stem Cell Transplantation for Osteonecrosis in Sickle Cell Disease
November 17, 2017 updated by: Vitor Fortuna, Federal University of Bahia
Treatment for Hip, Knee, Ankle and Shoulder Osteonecrosis With Autologous Mononuclear Cells Transplantation in People With Sickle Cell Disease
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Autologous bone marrow stem cell graft
Autologous bone marrow stem cell implantation
|
All patients will undergo autologous bone marrow stem cell implantation into the necrotic lesion area using a minimally invasive technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
60 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain intensity scale (0-10)
Time Frame: 60 months
|
VAS scoring system
|
60 months
|
|
Disease progression defined as progression to a fractural stage of osteonecrosis
Time Frame: 60 months
|
Radiographic signals
|
60 months
|
|
Reoperation rate
Time Frame: 60 months
|
Need for further surgery or hip replacement
|
60 months
|
|
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.
|
60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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 and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
August 1, 2018
Study Registration Dates
First Submitted
May 15, 2015
First Submitted That Met QC Criteria
May 18, 2015
First Posted (Estimate)
May 19, 2015
Study Record Updates
Last Update Posted (Actual)
November 20, 2017
Last Update Submitted That Met QC Criteria
November 17, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE 25000039812/2005-99
- 11738 (CONEP)
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