Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid Arthritis
NCT ID: NCT01873625
Last Updated: 2013-06-10
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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COMPLETED
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2009-10-31
2011-12-31
Brief Summary
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Detailed Description
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Patients were categorized according to the following stimulation protocols:
To assess the outcomes, after mesenchymal stem cells transplantation at months 1,3,6 and 12 we will examine the patients by: WOMAC questioners, DAS28 scoring , radiographies assessments and biochemical analysis with laboratory tests.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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placebo
Normal salin injection in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.
placebo
mesencymal stem cell
Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.
mesenchymal cell transplantation
Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.
Interventions
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mesenchymal cell transplantation
Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.
placebo
Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) ≤30 kg/m2
3. The presence of osteoarthritis based on MRI and American Rheumatism Association criteria since 6 months before invitation
Exclusion Criteria
10 Years
65 Years
ALL
No
Sponsors
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Royan Institute
OTHER_GOV
Responsible Party
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Principal Investigators
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Hamid Gourabi, PhD
Role: STUDY_CHAIR
Head of Royan Institute
Nasser Aghdami, MD,PhD
Role: STUDY_DIRECTOR
Head of regenerative medicine department, head of Royan cell therapy center
Mohsen Emadedin, MD
Role: STUDY_DIRECTOR
Royan Institute,Department of regenerative medicine
Farhad gharibdoost, MD
Role: STUDY_DIRECTOR
President of rheumatologic association center of Iran
Soraya Shadmanfar, MD
Role: PRINCIPAL_INVESTIGATOR
Royan Institute, Department of regenerative medicine
Locations
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Royan Institute
Tehran, , Iran
Countries
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References
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Shadmanfar S, Labibzadeh N, Emadedin M, Jaroughi N, Azimian V, Mardpour S, Kakroodi FA, Bolurieh T, Hosseini SE, Chehrazi M, Niknejadi M, Baharvand H, Gharibdoost F, Aghdami N. Intra-articular knee implantation of autologous bone marrow-derived mesenchymal stromal cells in rheumatoid arthritis patients with knee involvement: Results of a randomized, triple-blind, placebo-controlled phase 1/2 clinical trial. Cytotherapy. 2018 Apr;20(4):499-506. doi: 10.1016/j.jcyt.2017.12.009. Epub 2018 Feb 7.
Related Links
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Related Info
Other Identifiers
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Royan-RA-001
Identifier Type: -
Identifier Source: org_study_id
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