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

NCT06361485 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-04-11

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

BIOLOGICAL

Lumbar Injections with 10cc's of Wharton's Jelly Allograft

Low Back Injections with Minimal Manipulation Umbilical Cord Tissue

Sponsors & Collaborators

  • R3 Medical Research

    collaborator INDUSTRY

  • R3 Stem Cell

    lead INDUSTRY

Principal Investigators

  • James Faber, BA · Institute of Cellular and Regenerative Medicine IRB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2027-03-31
Completion
2028-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06361485 on ClinicalTrials.gov