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NCT06608134 · ClinicalTrials.gov registry record · Early Phase 1

Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis

A Early Phase 1 study of Osteoarthritis, Knee, sponsored by R3 Medical Research.

Recruiting
Registry status
Early Phase 1
Development phase
120
Enrollment target
5
Study locations

NCT06608134: Recruiting Early Phase 1 study of Osteoarthritis, Knee, sponsored by R3 Medical Research.

NCT06608134 is a Early Phase 1 study of Osteoarthritis, Knee that is actively recruiting participants, run by R3 Medical Research. The registered enrollment target is 120 participants, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (76% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06608134, a Early Phase 1 study of Osteoarthritis, Knee, is actively recruiting participants, sponsored by R3 Medical Research.

RECRUITING
Registry status
Early Phase 1
Development phase
120 participants
Enrollment target
5
Study locations

Study Summary

This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled evaluating safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee osteoarthritis. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.

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 Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection

Study Locations (5)

California

  • R3 Anti Aging Beverly Hills - Beverly Hills
  • Optimal Medical Group - Fresno

Arizona

  • R3 Anti Aging Scottsdale - Scottsdale

New York

  • Scheer Medical Wellness - New York

Texas

  • Dr. Duc (Steve) Le, MD - Cleveland

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2024-10-01
Est. Completion 2029-10-01
Phase Early Phase 1
R3 Medical Research

1 total trials

What NCT06608134 shows while recruiting

NCT06608134 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (76% lower).

The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 1 intervention - of which Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection is the first listed.

NCT06608134 lists 5 locations in 4 states (California, Arizona, New York).

Frequently Asked Questions

What is clinical trial NCT06608134 about?

NCT06608134 is a clinical study titled "Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis". This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled evaluating safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee osteoarthritis. The participants will be randomized to one of thre...

What is the current status of trial NCT06608134?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 120 participants. The study started on 2024-10-01. Estimated completion is 2029-10-01.

What conditions does trial NCT06608134 study?

This clinical trial studies the following conditions: Osteoarthritis, Knee.

What interventions are being tested in trial NCT06608134?

The interventions under investigation include: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection (BIOLOGICAL).

Who is sponsoring clinical trial NCT06608134?

This trial is sponsored by R3 Medical Research, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06608134 being conducted?

This trial has 5 study locations across Arizona, California, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Osteoarthritis, Knee

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 NCT06608134's enrollment target sits among peer trials

120 55th of 112 higher than 55 of 112 other Osteoarthritis, Knee trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Osteoarthritis, Knee 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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Source: ClinicalTrials.gov NCT06608134, the US trial registry maintained by the National Library of Medicine. NCT06608134 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.