Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis
Recruiting
Early Phase 1
Interventional Study
Osteoarthritis, Knee
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 30 and older
- Sex
- Any
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- R3 Medical Research · Industry
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About This Trial
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 lo…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 fe…
Contacts
No contact information available.