Evaluation of Outcomes With Umbilical Cord Allograft for Musculoskeletal Conditions Musculoskeletal Conditions

Part of paid clinical trials in Encino, California.

Sponsor
R3 Stem Cell
Study ID
NCT03390920
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Umbilical Allograft — OTHER
    The umbilical allograft is regulated by the FDA and comes from a lab that is FDA registered.

Study Details

The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for pain relief and functional improvements for all types of musculoskeletal conditions. The study is prospective, with outcome measures being obtained at numerous time points after the regenerative procedure.

Key Dates

Start date
Jan 1, 2022
Status verified
Sep 2021
Primary completion
Jan 1, 2025
Completion
Jan 1, 2030

Study Design

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

Arms

  • Experimental: Umbilical Allograft
    The study is nonrandomized with one arm. Depending on the body area being treated, the amount of the product utilized will be either 1.0cc's or 2cc's.

Primary Outcome Measure

Short Musculoskeletal Function Assessment Questionnaire (SMFA) [ Time Frame: Baseline and then Assess Changes Post Intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Advanced Stem Cell InstituteEncinoCalifornia91316
David Greene, PhD
844-438-7836

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