CompletedNot Applicable

Effect of Implanting Allogenic Cytokines Derived From Human Amniotic Membrane (HAM) and Mesenchymal Stem Cells Derived From Human Umbilical Cord Wharton's Jelly (HUMCWJ) on Pain and Functioning of Knee Osteoarthritis

United States60 participantsStarted 2017-11-09

Plain-language summary

The purpose of this study is to compare the pain, functioning and pain medication consumption of knee osteoarthritis (OA) patients who have allogenic cytokines derived from human amniotic membranes (HAM) and allogenic mesenchymal stem cells derived from human umbilical cord Wharton's Jelly (HUMCWJ) implanted into the affected knee with knee OA patients who self-select to be in a non-intervention control group.

Who can participate

Age range

50 Years – 85 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: * knee OA patients who are eligible for HAM and HUMCWJ therapy of their knee, no previous HAM or HUMCWJ therapy, between the ages of 50-85, independently residing in the community, no previously diagnosed cognitive decline or mental illness, and not taking pain medication more than once per week for a condition other than knee OA Exclusion Criteria: * Allergy to or use of penicillin, streptomycin, emphotericin B or dimethylsulfoxide. DMSO allergies and any immunocompromised conditions will also be excluded

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

Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) over 3 months

Timeframe: Baseline (T0), 4 weeks (T1), 3 months (T2)

Change in pain during sit-to-stand over 3 months

Timeframe: Baseline (T0), 4 weeks (T1), 3 months (T2)

Change in pain during supine to upright over 3 months

Timeframe: Baseline (T0), 4 weeks (T1), 3 months (T2)

Change in pain during ascent/decent stairs over 3 months

Timeframe: Baseline (T0), 4 weeks (T1), 3 months (T2)

Trial details

NCT IDNCT03337243

SponsorSport and Spine Rehab Clinical Research Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-26

View on ClinicalTrials.gov More Knee Osteoarthritis trials

Plain-language summary

Who can participate

Age range

50 Years – 85 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

Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) over 3 months

Timeframe: Baseline (T0), 4 weeks (T1), 3 months (T2)

Change in pain during sit-to-stand over 3 months

Timeframe: Baseline (T0), 4 weeks (T1), 3 months (T2)

Change in pain during supine to upright over 3 months

Timeframe: Baseline (T0), 4 weeks (T1), 3 months (T2)

Change in pain during ascent/decent stairs over 3 months

Timeframe: Baseline (T0), 4 weeks (T1), 3 months (T2)