Clinical trial NCT03866330: Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis
Official title: Effectiveness of Wharton's Jelly-derived Stem Cells in Patients With Osteoarthritis of the Knee, Hip or Glenohumeral Joint and Analysis of the Regeneration Processes Based on Inflammatory Markers, microRNAs and Clinical Features
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Hip Osteoarthritis
Knee Osteoarthritis
Glenohumeral Osteoarthritis
Keywords: Osteoarthritis
Wharton Jelly derived Mesenchymal Stem Cells
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: HIP DISABILITY AND OSTEOARTHRITIS OUTCOME SCORE (HOOS)
timeFrame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
measure: Harris Hip Score
timeFrame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
measure: modified Harris Hip Score for knee
timeFrame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
measure: The International Knee Documentation Committee (IKDC Questionnaire)
timeFrame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
measure: WOMAC (for hip and knee)
timeFrame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
measure: Disability of Arm, Shoulder and Hand [DASH]
timeFrame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
measure: The Constant-Murley score (CMS)
timeFrame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
measure: Visual Analog Scale (VAS)
timeFrame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
Secondary outcomes:
measure: 1. Nature, incidence and severity of adverse events (AEs)
timeFrame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
measure: 2. Change in radiographic/magnetic resonance joint morphology
timeFrame: Baseline, and 12 months post-treatment cycle
measure: 3. Change in cartilage thickness
timeFrame: Baseline, and 12 months post-treatment cycle
measure: 4. Change in cartilage volume
timeFrame: Baseline, and 12 months post-treatment cycle
measure: 5. Change in cartilage morphology
timeFrame: Baseline, and 12 months post-treatment cycle
measure: 6. Change in subchondral bone morphology
timeFrame: Baseline, and 12 months post-treatment cycle
measure: 8. Inflammation monitoring
timeFrame: Baseline, and 12 months post-treatment cycle]
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Life Clinic
state: Mazovian
Study officials:
affiliation: Medical University of Warsaw
name: Marek Postula, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: