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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 March 2016 |
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Main ID: |
NCT02118519 |
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Date of registration:
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24/01/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mesenchymal Stem Cells in Knee Cartilage Injuries
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Scientific title:
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Use of Mesenchymal Stem Cells for the Repair of Articular Cartilage Disorder of Knee Using Intra-articular Injection of Mesenchymal Cells Alone or Mesenchymal Cells With Platelet Lysate |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02118519 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Jordan
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Contacts
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Name:
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Hiba Khalil, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Al-Neelain University |
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Name:
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Abdallah Awidi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cell Therapy Center |
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Name:
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Mahasen S Najjar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Jordan University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- MRI must show moderate/severe articular injury
- 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:
- Lesion size
- 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
Age minimum:
40 Years
Age maximum:
68 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Articular Cartilage Disorder of Knee
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Osteoarthritis, Knee
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Intervention(s)
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Biological: Autologous Mesenchymal Stem Cells
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Primary Outcome(s)
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Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.
[Time Frame: 12 months]
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Secondary Outcome(s)
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Assessment of the articular cartilage healing in osteoarthritic patients through intra articular injection of Autologus Mesenchymal stem cell with/or without supported product.
[Time Frame: 12 months]
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Secondary ID(s)
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KneeUJCTC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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