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Clinical Trial Summary

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.


Clinical Trial Description

This is a prospective, open label, non-controlled Pilot study in which the safety and feasibility of umbilical cord Wharton's Jelly (WJ) allograft will be evaluated in participants suffering with lumbar pain. The participants will receive a series of lumbar injections described in the protocol. As this is a Pilot study primarily designed to evaluate safety, no control will be used. The dosing will consist of 10cc WJ Allograft with 100 total participants. In addition to baseline outcome instruments along with imaging and laboratory studies, participants will be followed for one year for evaluation of safety, pain relief and functional improvements. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06361485
Study type Interventional
Source R3 Stem Cell
Contact David L Greene, MD, PhD, MBA
Phone (602) 677-8981
Email dgreene@r3medicalresearch.com
Status Recruiting
Phase Phase 1
Start date March 25, 2024
Completion date April 1, 2028

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