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
13 participants
INTERVENTIONAL
2014-01-31
2015-08-31
Brief Summary
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Detailed Description
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The patients are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.
The investigators hypothesize that the two groups will give satisfactory clinical outcomes, but the investigators are looking forward to assessing the best product that will activate chondrogenesis and heal cartilaginous injury.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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mesenchymal stem cells
Autologous Mesenchymal Stem Cells primed prior to intra articular injection into knees of patients with advanced articular cartilage injury
Autologous Mesenchymal Stem Cells
Comparison of clinical outcomes of patients injected by mesenchymal stem cells only with patients injected with mesenchymal stem cells supported by platelet lysate
mesenchymal cells&platelet lysate
Autologous Mesenchymal Stem Cells primed prior to intra articular injection with platelet lysate into knees of patients with advanced articular cartilage injury
Autologous Mesenchymal Stem Cells
Comparison of clinical outcomes of patients injected by mesenchymal stem cells only with patients injected with mesenchymal stem cells supported by platelet lysate
Interventions
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Autologous Mesenchymal Stem Cells
Comparison of clinical outcomes of patients injected by mesenchymal stem cells only with patients injected with mesenchymal stem cells supported by platelet lysate
Eligibility Criteria
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Inclusion Criteria
* Serum collagen II must be above the normal value.
* Lesion site: Femoral and Tibial condyles or patella
* Admission of steroid , NSAID, pain killers must be stopped before 1 month
Exclusion Criteria
* PT and PTT not within normal value
* Complete blood count ( Hb, PCV, and RBC) not within the normal value
* HIV and Hepatitis Antigens (B and C) detection
40 Years
68 Years
ALL
No
Sponsors
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University of Jordan
OTHER
Responsible Party
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Fatima Jamali
Researcher
Principal Investigators
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Abdallah Awidi, MD
Role: STUDY_DIRECTOR
Cell Therapy Center
Mahasen S Najjar, MD
Role: PRINCIPAL_INVESTIGATOR
Jordan University Hospital
Hiba Khalil, PhD
Role: PRINCIPAL_INVESTIGATOR
Al-Neelain University
Locations
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Cell Therapy Center, Jordan University Hospital
Amman, , Jordan
Countries
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References
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Al-Najar M, Khalil H, Al-Ajlouni J, Al-Antary E, Hamdan M, Rahmeh R, Alhattab D, Samara O, Yasin M, Abdullah AA, Al-Jabbari E, Hmaid D, Jafar H, Awidi A. Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study. J Orthop Surg Res. 2017 Dec 12;12(1):190. doi: 10.1186/s13018-017-0689-6.
Other Identifiers
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KneeUJCTC
Identifier Type: -
Identifier Source: org_study_id
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