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 range50 Years – 85 Years

SexALL

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

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 range50 Years – 85 Years

SexALL

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)