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Clinical Trials/NCT02118519
NCT02118519
Completed
Phase 2

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

University of Jordan1 site in 1 country13 target enrollmentJanuary 2014

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Articular Cartilage Disorder of Knee
Sponsor
University of Jordan
Enrollment
13
Locations
1
Primary Endpoint
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fatima Jamali

Researcher

University of Jordan

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

Outcomes

Primary Outcomes

Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.

Time Frame: 12 months

Secondary Outcomes

  • Assessment of the articular cartilage healing in osteoarthritic patients through intra articular injection of Autologus Mesenchymal stem cell with/or without supported product.(12 months)

Study Sites (1)

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