Knee Osteoarthritis Clinical Trial
Official title:
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
Verified date | May 2020 |
Source | Sport and Spine Rehab Clinical Research Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 26, 2019 |
Est. primary completion date | April 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Scott Medical Health Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sport and Spine Rehab Clinical Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) over 3 months | Baseline (T0), 4 weeks (T1), 3 months (T2) | ||
Primary | Change in pain during sit-to-stand over 3 months | Participants will perform as many sit-to-stand movements as they can in 30 seconds and then will rate pain | Baseline (T0), 4 weeks (T1), 3 months (T2) | |
Primary | Change in pain during supine to upright over 3 months | Participants will perform a supine to upright movement as quickly as they can and then will rate pain | Baseline (T0), 4 weeks (T1), 3 months (T2) | |
Primary | Change in pain during ascent/decent stairs over 3 months | Participants will ascend and decent 10 stairs as quickly as they can and then will rate pain | Baseline (T0), 4 weeks (T1), 3 months (T2) |
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