RecruitingOsteoarthritis, Knee
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis
Eligible age
30+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
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About this study
This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled evaluating safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee osteoarthritis. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.
Sponsor: R3 Medical Research
You may qualify if…
- ✓ Be over age 30
- ✓ Diagnosed with Grade II or III OA on the KL scale (in one knee).
- ✓ Body Mass Index (BMI) \<50Kg/m2
- ✓ Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS)
- ✓ Female patients must be abstinent, surgically sterilized or postmenopausal
- ✓ Premenopausal females must have a negative pregnancy test, on contraceptive measures and do not anticipate pregnancy during the duration of the study.
- ✓ Be willing and capable of giving written informed consent to participate in English.
- ✓ Be willing and capable of complying with study-related requirements, procedures and visits in English.
You may not qualify if…
- ✕ Have taken any pain medication including nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study injection date.
- ✕ Use anticoagulants have a substance abuse history and fail to agree not to take any knee-symptom modifying drugs during the course of the study without discussing and reporting the use to the site principal investigator and study team.
- ✕ Have had an intra-articular injection of any drug including viscosupplementation in the index knee in the past 6 months.
- ✕ Have had surgery on the index knee with the past 6 months.
- ✕ Had a traumatic injury to the index knee with the past 3 months.
- ✕ Planned elective surgery during the course of the study.
- ✕ A history of organ or hematologic transplantation, rheumatoid arthritis, or other autoimmune disorders.
- ✕ Be on immunosuppressive medications.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06608134 · last updated 2024-09-23