Mesenchymal Stem Cells in Knee Cartilage Injuries

Phase 2

Completed

• Conditions: Articular Cartilage Disorder of Knee; Osteoarthritis, Knee
• Interventions: Biological: Autologous Mesenchymal Stem Cells

• Registration Number: NCT02118519
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-24
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mesenchymal stem cells	Autologous Mesenchymal Stem Cells	Autologous Mesenchymal Stem Cells primed prior to intra articular injection into knees of patients with advanced articular cartilage injury
mesenchymal cells&platelet lysate	Autologous Mesenchymal Stem Cells	Autologous Mesenchymal Stem Cells primed prior to intra articular injection with platelet lysate into knees of patients with advanced articular cartilage injury

Primary Outcome Measures

Name	Time	Method
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.	12 months

Secondary Outcome Measures

Name	Time	Method
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	For every patient tests would be performed repeated at 6, and 12 months post-injection.

Trial Locations

Locations (1)

Cell Therapy Center, Jordan University Hospital; 🇯🇴 Amman, Jordan