Mesenchymal Stem Cells in Knee Cartilage Injuries

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118519
• Other study ID #: KneeUJCTC
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2014
• Last updated: February 23, 2016
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 68 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Articular Cartilage Disorder of Knee
• Cartilage Diseases
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Jordan	Cell Therapy Center, Jordan University Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.		12 months	Yes
Secondary	Assessment of the articular cartilage healing in osteoarthritic patients through intra articular injection of Autologus Mesenchymal stem cell with/or without supported product.	For every patient tests would be performed repeated at 6, and 12 months post-injection.	12 months	No