R3 Medical Research
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.
Osteoarthritis, Knee
Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
EARLY_PHASE1
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 (Low Dose), 3cc WJ Allograft (Medium Dose), or 4cc WJ Allograft (High Dose) with 120 total patients randomized into the three arms equally. In addition to baseline outcome instruments along with imaging and laboratory studies, patients will be followed for one year for evaluation of safety, pain relief and functional improvements.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 120 participants |
Masking : | DOUBLE |
Masking Description : | With double blinding of the allograft neither participant nor provider will know what is being administered. |
Primary Purpose : | TREATMENT |
Official Title : | Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for |
Actual Study Start Date : | 2024-10-01 |
Estimated Primary Completion Date : | 2028-10-01 |
Estimated Study Completion Date : | 2029-10-01 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 30 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
R3 Anti Aging Scottsdale
Scottsdale, arizona, United States, 85262
RECRUITING
R3 Anti Aging Beverly Hills
Beverly Hills, California, United States, 90210
RECRUITING
Optimal Medical Group
Fresno, California, United States, 93722
RECRUITING
Scheer Medical Wellness
New York, New York, United States, 10036
RECRUITING
Dr. Duc (Steve) Le, MD
Cleveland, Texas, United States, 77327