Mesenchymal Stem Cells in Knee Cartilage Injuries
Primary Purpose
Articular Cartilage Disorder of Knee, Osteoarthritis, Knee
Status
Completed
Phase
Phase 2
Locations
Jordan
Study Type
Interventional
Intervention
Autologous Mesenchymal Stem Cells
Sponsored by
About this trial
This is an interventional treatment trial for Articular Cartilage Disorder of Knee focused on measuring Bone marrow derived Mesenchymal Stem Cells, Knee articular cartilage injury, Chondrogenesis, orthopedics
Eligibility 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
Sites / Locations
- Cell Therapy Center, Jordan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
mesenchymal stem cells
mesenchymal cells&platelet lysate
Arm Description
Autologous Mesenchymal Stem Cells primed prior to intra articular injection into knees of patients with advanced articular cartilage injury
Autologous Mesenchymal Stem Cells primed prior to intra articular injection with platelet lysate into knees of patients with advanced articular cartilage injury
Outcomes
Primary Outcome Measures
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.
Secondary Outcome Measures
Assessment of the articular cartilage healing in osteoarthritic patients through intra articular injection of Autologus Mesenchymal stem cell with/or without supported product.
For every patient tests would be performed repeated at 6, and 12 months post-injection.
Full Information
NCT ID
NCT02118519
First Posted
January 24, 2014
Last Updated
February 23, 2016
Sponsor
University of Jordan
1. Study Identification
Unique Protocol Identification Number
NCT02118519
Brief Title
Mesenchymal Stem Cells in Knee Cartilage Injuries
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular Cartilage Disorder of Knee, Osteoarthritis, Knee
Keywords
Bone marrow derived Mesenchymal Stem Cells, Knee articular cartilage injury, Chondrogenesis, orthopedics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mesenchymal stem cells
Arm Type
Active Comparator
Arm Description
Autologous Mesenchymal Stem Cells primed prior to intra articular injection into knees of patients with advanced articular cartilage injury
Arm Title
mesenchymal cells&platelet lysate
Arm Type
Active Comparator
Arm Description
Autologous Mesenchymal Stem Cells primed prior to intra articular injection with platelet lysate into knees of patients with advanced articular cartilage injury
Intervention Type
Biological
Intervention Name(s)
Autologous Mesenchymal Stem Cells
Intervention Description
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 Measure Information:
Title
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Assessment of the articular cartilage healing in osteoarthritic patients through intra articular injection of Autologus Mesenchymal stem cell with/or without supported product.
Description
For every patient tests would be performed repeated at 6, and 12 months post-injection.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdallah Awidi, MD
Organizational Affiliation
Cell Therapy Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mahasen S Najjar, MD
Organizational Affiliation
Jordan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hiba Khalil, PhD
Organizational Affiliation
Al-Neelain University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cell Therapy Center, Jordan University Hospital
City
Amman
ZIP/Postal Code
11942
Country
Jordan
12. IPD Sharing Statement
Citations:
PubMed Identifier
29233163
Citation
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.
Results Reference
derived
Learn more about this trial
Mesenchymal Stem Cells in Knee Cartilage Injuries
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