Status:
UNKNOWN
Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis
Lead Sponsor:
Medical University of Warsaw
Conditions:
Osteoarthritis
Hip Osteoarthritis
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
PHASE2
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 ...
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03866330
Start Date
March 1 2019
End Date
March 1 2022
Last Update
March 8 2019
Active Locations (1)
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1
Life Clinic
Warsaw, Mazovian, Poland, 00-132