Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for
R3 Medical Research
Summary
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.
Description
This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled study in which the safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee OA. 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. As this is a Pilot Study primarily designed to evaluate safety, no control will be used. The dosing groups will consist of either 2cc WJ Allograft (L…
Eligibility
- Age range
- 30+ years
- Sex
- All
- Healthy volunteers
- No
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 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, procedu…
Interventions
- BiologicalUmbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
Direct injection of biologic into the knee joint.
Locations (5)
- R3 Anti Aging ScottsdaleScottsdale, Arizona
- R3 Anti Aging Beverly HillsBeverly Hills, California
- Optimal Medical GroupFresno, California
- Scheer Medical WellnessNew York, New York
- Dr. Duc (Steve) Le, MDCleveland, Texas