Actively Recruiting
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis
Led by R3 Medical Research · Updated on 2024-09-23
120
Participants Needed
5
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be over age 30
- Diagnosed with Grade II or III osteoarthritis in one knee
- Body Mass Index (BMI) under 50 kg/m2
- Have a pain score of 4 or more on the Numeric Pain Rating Scale
- Female patients must be abstinent, surgically sterilized, or postmenopausal
- Premenopausal females must have a negative pregnancy test, use contraceptives, and not plan pregnancy during the study
- Able and willing to give written informed consent in English
- Able and willing to follow study procedures and visits in English
You will not qualify if you...
- Taken any pain medication including NSAIDs within 2 weeks before the injection
- Use anticoagulants, have substance abuse history, or take knee-symptom modifying drugs without reporting to the study team
- Had any intra-articular injection or surgery on the study knee within the past 6 months
- Had a traumatic injury to the study knee within the past 3 months
- Have planned elective surgery during the study
- History of organ or blood transplant, rheumatoid arthritis, or other autoimmune disorders
- Use immunosuppressive medications
- Diagnosed with cancer within the past 2 years
- Have or recently treated knee infection within the past 3 months
- Participated in another clinical trial or received investigational treatment within 30 days before this study
- Are breastfeeding, pregnant, or plan to become pregnant during the study
- Have contraindications to X-rays or MRI scans
- Have serious neurological, psychological, or psychiatric disorders
- Have injury or disability claims involved in current litigation or worker's compensation
- Known allergy to amphotericin-B, ciprofloxacin, gentamycin, penicillin, or streptomycin
AI-Screening
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Trial Site Locations
Total: 5 locations
1
R3 Anti Aging Scottsdale
Scottsdale, Arizona, United States, 85262
Actively Recruiting
2
R3 Anti Aging Beverly Hills
Beverly Hills, California, United States, 90210
Actively Recruiting
3
Optimal Medical Group
Fresno, California, United States, 93722
Actively Recruiting
4
Scheer Medical Wellness
New York, New York, United States, 10036
Actively Recruiting
5
Dr. Duc (Steve) Le, MD
Cleveland, Texas, United States, 77327
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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