Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
R3 Stem Cell
Study ID
NCT06361485
Phase
PHASE1
Status
Recruiting
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Conditions

  • Low Back Pain

Eligibility Criteria

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

Interventions

  • Lumbar Injections with 10cc's of Wharton's Jelly Allograft — BIOLOGICAL
    Low Back Injections with Minimal Manipulation Umbilical Cord Tissue

Study Details

This is a Pilot Study that is an open label, prospective, non-controlled study in which the safety and feasibility of Wharton's Jelly (WJ) allograft will be evaluated in 100 participants suffering with low back pain.

Key Dates

Start date
Mar 25, 2024
Status verified
Apr 2024
Primary completion
Mar 31, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lumbar Injection Arm
    Lumbar Injections with 10cc's of Umbilical Cord Wharton's Jelly Allograft (BelloWJY)

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
R3 Anti Aging ScottsdaleScottsdaleArizona85262
David Greene, MD, PhD, MBA
[email protected]
480-306-6256
Sabrina Solt, NMD (PRINCIPAL_INVESTIGATOR)
R3 Anti Aging Beverly HillsBeverly HillsCalifornia90210
Kathleen Francesca, BA
[email protected]
424-382-1074
Neville Campbell, MD (PRINCIPAL_INVESTIGATOR)
Scheer Medical WellnessNew YorkNew York10036
Alexandre Scheer, MD
[email protected]
646-762-9499
Alexandre Scheer, MD (PRINCIPAL_INVESTIGATOR)
Dr. Duc (Steve) Le, MDClevelandTexas77327
Steve Le, MD
[email protected]
281-593-1500
Steve Le, MD (PRINCIPAL_INVESTIGATOR)

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

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