Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis

Medical University of Warsaw

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Osteoarthritis; Glenohumeral Osteoarthritis; Hip Osteoarthritis; Knee Osteoarthritis

Treatments: Biological: Intraarticular injection of WJMSC

Study type: Interventional

Funder types: Other

Identifiers

NCT03866330

001/LIFE/2019

Details and patient eligibility

About

This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/ glenohumeral joint will be enrolled according to strict inclusion and exclusion criteria. Subjects will receive every three months a single dose of at least 10 million of Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) form the Polish Stem Cell Bank for 12 months (maximum four doses in total and at least 40 million of WJMSC in total) via ultrasound guided intra-articular injection.

Full description

This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/ glenohumeral joint will be enrolled according to strict inclusion and exclusion criteria. All patients are selected and sign consent forms, then divided into 3 groups based on clinical presentation. Subjects will receive a single dose of at least 10 million of Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) prepared by the Polish Stem Cell Bank every three months for 12 months (maximum four doses in total and at least 40 million of WJMSC in total) via ultrasound guided intra-articular injection. During the study period and 24 months after last injection they will be followed by clinical assessment, laboratory investigations including inflammatory markers and microRNA, as well as magnetic resonance imaging (MRI) of the injected joint. The investigators will also determine the local and systemic safety of the procedure and therapy with WJMSC.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• presence of osteoarthritis of the knee, hip or glenohumeral joint,
• confirmation cartilage injury, articular cartilage part or full-thickness injury by MR (Magnetic Resonance),
• joint pain of VAS (visual analog scale score) is 1 or higher while resting, 2 and higher during any physical activity,
• loss of joint function based on scale specific for certain joints; for hip: HHS scale (Harris Hip Score), HOOS scale (Hip disability and Osteoarthritis Outcome Score), The Western Ontario and McMaster Universities Arthritis Index (WOMAC); for knee: modified HHS score (Harris Hip Score), The Western Ontario and McMaster Universities Arthritis Index (WOMAC), The International Knee Documentation Committee (IKDC Questionnaire) and KOOS scale (Osteoarthritis Outcome Score); glenohumeral joint: Disability of Arm, Shoulder and Hand [DASH], CONSTANT score,
• clinical indication for surgical intervention,
• no effect of pharmacotherapy according to The World Health Organization (WHO) analgesic ladder lasting at least 6 months,
• no effect of physical rehabilitation lasting at least 6 months,
• willing to participate understand and sign the consent form of this study.

Exclusion criteria

• active inflammatory disease or infection,
• skin disease/infection around joint,
• severe heart failure,
• anemia,
• active/history of human immunodeficiency viruses (HIV), the hepatitis B virus (HBV) or the hepatitis C virus (HCV) infection,
• pregnant or breast-feeding women,
• mental disease, addiction to drugs or alcohol,
• participate other clinical experiments in 6 months,
• refuse to sign the consent form, or cannot keep follow-up visit.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

osteoarthritis of the knee

Active Comparator group

Description:

Intraarticular injection of WJMSC

Treatment:

Biological: Intraarticular injection of WJMSC

osteoarthritis of the hip

Active Comparator group

Description:

Intraarticular injection of WJMSC

Treatment:

Biological: Intraarticular injection of WJMSC

osteoarthritis of the glenohumeral joint

Active Comparator group

Description:

Intraarticular injection of WJMSC

Treatment:

Biological: Intraarticular injection of WJMSC