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Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain - Trial NCT06361485

Access comprehensive clinical trial information for NCT06361485 through Pure Global AI's free database. This Phase 1 trial is sponsored by R3 Stem Cell and is currently Recruiting. The study focuses on Low Back Pain. Target enrollment is 100 participants.

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NCT06361485
Phase 1
Recruiting
biological
Trial Details
ClinicalTrials.gov • NCT06361485
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Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain

Study Focus

Low Back Pain

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

Interventional

biological

Sponsor & Location

R3 Stem Cell

Scottsdale,Beverly Hills,New York,Cleveland, United States of America

Timeline & Enrollment

Phase 1

Mar 25, 2024

Apr 01, 2028

100 participants

Primary Outcome

C-reactive protein,Erythrocyte sedimentation rate,Alanine transaminase (ALT),Aspartate transaminase (AST),Alkaline phosphatase (ALP),Albumin,Creatinine,Blood Urea Nitrogen (BUN)

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.

ICD-10 Classifications

Low back pain
Pain in thoracic spine
Contusion of lower back and pelvis
Injuries to the abdomen, lower back, lumbar spine and pelvis
Sprain and strain of lumbar spine

Data Source

ClinicalTrials.gov

NCT06361485

Non-Device Trial