Mesenchymal Stem Cells in Knee Cartilage Injuries

University of Jordan

Status and phase: Completed; Phase 2

Conditions: Articular Cartilage Disorder of Knee; Osteoarthritis, Knee

Treatments: Biological: Autologous Mesenchymal Stem Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02118519

KneeUJCTC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 40 to 68 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 2 patient groups

mesenchymal stem cells

Active Comparator group

Description:

Autologous Mesenchymal Stem Cells primed prior to intra articular injection into knees of patients with advanced articular cartilage injury

Treatment:

Biological: Autologous Mesenchymal Stem Cells

mesenchymal cells&platelet lysate

Active Comparator group

Description:

Autologous Mesenchymal Stem Cells primed prior to intra articular injection with platelet lysate into knees of patients with advanced articular cartilage injury

Treatment:

Biological: Autologous Mesenchymal Stem Cells