Mesenchymal Stem Cells in Knee Cartilage Injuries

February 23, 2016 updated by: Fatima Jamali, University of Jordan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11942
        • Cell Therapy Center, Jordan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Investigators

  • Principal Investigator: Mahasen S Najjar, MD, Jordan University Hospital
  • Principal Investigator: Hiba Khalil, PhD, Al-Neelain University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KneeUJCTC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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