Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
R3 Medical Research
Study ID
NCT06608134
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection — BIOLOGICAL
    Direct injection of biologic into the knee joint.

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Sep 2024
Primary completion
Oct 1, 2028
Completion
Oct 1, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 2cc WJ Allograft (Low Dose)
    The 2cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Low Dose Group.
  • Active Comparator: 3cc WJ Allograft (Medium Dose)
    The 3cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Medium Dose Group.
  • Active Comparator: 4cc WJ Allograft (High Dose)
    The 4cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the High Dose Group.

Primary Outcome Measure

C Reactive Protein [ Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year ]

Locations (5)

FacilityCityStateZIPSite coordinators
R3 Anti Aging ScottsdaleScottsdaleArizona85262
Dr. Sabrina Solt, NMD
[email protected]
480-306-6256
R3 Anti Aging Beverly HillsBeverly HillsCalifornia90210
Neville Campbell, MD
[email protected]
424-382-1074
Optimal Medical GroupFresnoCalifornia93722
Dr. Lucia Mireles-Chavez, MD
[email protected]
559-425-1118
Scheer Medical WellnessNew YorkNew York10036
Dr. Alexandre Scheer, MD
[email protected]
212-391-8080
Dr. Duc (Steve) Le, MDClevelandTexas77327
Duc Le, MD
[email protected]
281-593-1500
Duc L, MD (SUB_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
R3 Anti Aging Scottsdale· Scottsdale, AZR3 Anti Aging Beverly Hills· Beverly Hills, CAOptimal Medical Group· Fresno, CAScheer Medical Wellness· New York, NYDr. Duc (Steve) Le, MD· Cleveland, TX

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