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
- Degenerative Arthritis
- Degenerative Disc Disease
- Ligament Injury
- Neuropathy
- Osteoarthritis
- Pelvic Pain
- Sports Injury
- Tendinitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Umbilical Allograft — OTHERThe 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 AllograftThe 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
- David Greene, PhD, MBA844-438-7836
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Advanced Stem Cell Institute | Encino | California | 91316 |
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