Clinical trial NCT02118519: Mesenchymal Stem Cells in Knee Cartilage Injuries
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Articular Cartilage Disorder of Knee
Osteoarthritis, Knee
Keywords: Bone marrow derived Mesenchymal Stem Cells
Knee articular cartilage injury
Chondrogenesis
orthopedics
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of the articular cartilage healing in osteoarthritic patients through intra articular injection of Autologus Mesenchymal stem cell with/or without supported product.
timeFrame: 12 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center, Jordan University Hospital
Study officials:
affiliation: Cell Therapy Center
name: Abdallah Awidi, MD
role: STUDY_DIRECTOR
affiliation: Jordan University Hospital
name: Mahasen S Najjar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Neelain University
name: Hiba Khalil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Najar M, Khalil H, Al-Ajlouni J, Al-Antary E, Hamdan M, Rahmeh R, Alhattab D, Samara O, Yasin M, Abdullah AA, Al-Jabbari E, Hmaid D, Jafar H, Awidi A. Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study. J Orthop Surg Res. 2017 Dec 12;12(1):190. doi: 10.1186/s13018-017-0689-6.