NCT06361485

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: R3 Stem Cell · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
BIOLOGICAL	Lumbar Injections with 10cc's of Wharton's Jelly Allograft	Low Back Injections with Minimal Manipulation Umbilical Cord Tissue

Timeline

• Start date: 2024-03-25
• Primary completion: 2027-03-31
• Completion: 2028-04-01
• First posted: 2024-04-11
• Last updated: 2024-04-11

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study