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NCT06361485 · ClinicalTrials.gov registry record · Phase 1
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
A Phase 1 study of Low Back Pain, sponsored by R3 Stem Cell.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 4
- Study locations
NCT06361485: Recruiting Phase 1 study of Low Back Pain, sponsored by R3 Stem Cell.
NCT06361485 is a Phase 1 study of Low Back Pain that is actively recruiting participants, run by R3 Stem Cell. The registered enrollment target is 100 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (80% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06361485, a Phase 1 study of Low Back Pain, is actively recruiting participants, sponsored by R3 Stem Cell.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
C-reactive protein (CRP) is a protein made by the liver. The level of CRP increases when there's inflammation in the body. A simple blood test can check your C-reactive protein level. C-reactive protein is measured in milligrams per liter (mg/L). Results equal to or greater than 8 mg/L or 10 mg/L are considered high. Range values vary depending on the lab doing the test. A high test result is a sign of inflammation. It may be due to serious infection, injury or chronic disease. Your health car
Conditions Studied
Interventions
- BIOLOGICAL Lumbar Injections with 10cc's of Wharton's Jelly Allograft
Study Locations (4)
Arizona
- R3 Anti Aging Scottsdale - Scottsdale
California
- R3 Anti Aging Beverly Hills - Beverly Hills
New York
- Scheer Medical Wellness - New York
Texas
- Dr. Duc (Steve) Le, MD - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-03-25 |
| Est. Completion | 2028-04-01 |
| Phase | Phase 1 |
What NCT06361485 shows while recruiting
NCT06361485 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Low Back Pain appearing as the primary indexed condition, and to 1 intervention - of which Lumbar Injections with 10cc's of Wharton's Jelly Allograft is the first listed.
NCT06361485 reports a single indexed study location in Arizona, California, New York.
Frequently Asked Questions
What is clinical trial NCT06361485 about?
NCT06361485 is a clinical study titled "Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain". 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.
What is the current status of trial NCT06361485?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2024-03-25. Estimated completion is 2028-04-01.
What conditions does trial NCT06361485 study?
This clinical trial studies the following conditions: Low Back Pain.
What interventions are being tested in trial NCT06361485?
The interventions under investigation include: Lumbar Injections with 10cc's of Wharton's Jelly Allograft (BIOLOGICAL).
Who is sponsoring clinical trial NCT06361485?
This trial is sponsored by R3 Stem Cell, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06361485 being conducted?
This trial has 4 study locations across Arizona, California, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Low Back Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06361485's enrollment target sits among peer trials
100 57th of 122 higher than 63 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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