UnknownPhase 1/2

Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis

Poland100 participantsStarted 2019-03-01

Plain-language 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.

Who can participate

Age range

30 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)]

Harris Hip Score

Timeframe: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]

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)]

modified Harris Hip Score for knee

Timeframe: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]

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)]

WOMAC (for hip and knee)

Timeframe: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)

Trial details

NCT IDNCT03866330

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

Contact for this trial

Marek Postula, MD, PhD

+48605113346 mpostula@wum.edu.pl

View on ClinicalTrials.gov More Osteoarthritis trials

Plain-language summary

Who can participate

Age range

30 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)]

Harris Hip Score

Timeframe: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]

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)]

modified Harris Hip Score for knee

Timeframe: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]

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)]

WOMAC (for hip and knee)

Timeframe: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)