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Completed

NCT Number: NCT02118519

Mesenchymal Stem Cells in Knee Cartilage Injuries

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.

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Key information

Conditions

Articular Cartilage Disorder of Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cell Therapy Center, Jordan University Hospital

Amman, 11942, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous mesenchymal stem cells

Biological

Comparison of clinical outcomes of patients injected by mesenchymal stem cells only with patients injected with mesenchymal stem cells supported by platelet lysate

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 21, 2014
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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