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

Recruiting Phase 1 Interventional Study
Low Back Pain
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
20 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
R3 Stem Cell · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: • Patient must * Be over age 20. * Suffering from chronic lumbar pain * Body Mass Index (BMI) \<50 Kilograms/m2. * Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS). * Female participants must be abstinent, surgically sterilized or postmenopausal. * Premenopausal …
Contacts

David L Greene, MD, PhD, MBA

(602) 677-8981

dgreene@r3medicalresearch.com

CONTACT

Katherine Minter-Dykhouse, PhD

4803066256

kmd@bello.bio

CONTACT