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Mesenchymal Stem Cells in Knee Cartilage Injuries

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ClinicalTrials.gov Identifier: NCT02118519
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Fatima Jamali, University of Jordan

Brief Summary:
Induction of autologous repair chondrogenesis to regenerate injured articular cartilage using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions.

Condition or disease Intervention/treatment Phase
Articular Cartilage Disorder of Knee Osteoarthritis, Knee Biological: Autologous Mesenchymal Stem Cells Phase 2

Detailed Description:

Fourteen patients from both genders, age range 40-68, will be enrolled according to strict inclusion and exclusion criteria, divided into two equal groups based upon receiving autologous MSCs alone, or MSCs supported by platelet lysate through percutaneous injection.

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: mesenchymal stem cells
Autologous Mesenchymal Stem Cells primed prior to intra articular injection into knees of patients with advanced articular cartilage injury
Biological: 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

Active Comparator: 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
Biological: 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




Primary Outcome Measures :
  1. Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]
    For every patient tests would be performed repeated at 6, and 12 months post-injection.



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Ages Eligible for Study:   40 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02118519


Locations
Jordan
Cell Therapy Center, Jordan University Hospital
Amman, Jordan, 11942
Sponsors and Collaborators
University of Jordan
Investigators
Study Director: Abdallah Awidi, MD Cell Therapy Center
Principal Investigator: Mahasen S Najjar, MD Jordan University Hospital
Principal Investigator: Hiba Khalil, PhD Al-Neelain University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fatima Jamali, Researcher, University of Jordan
ClinicalTrials.gov Identifier: NCT02118519     History of Changes
Other Study ID Numbers: KneeUJCTC
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016

Keywords provided by Fatima Jamali, University of Jordan:
Bone marrow derived Mesenchymal Stem Cells
Knee articular cartilage injury
Chondrogenesis
orthopedics

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Cartilage Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases