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ENROLLING BY INVITATION
NCT05400798
NA

A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears

Sponsor: InGeneron, Inc.

View on ClinicalTrials.gov

Summary

This is a longitudinal follow-up study of the RC-002 study, in which up to 246 subjects assigned to two randomization arms will be enrolled: an adipose-derived regenerative cell (ADRC) injection arm (ADRC treatment arm) and the SOC corticosteroid injection arm (active control arm). All subjects will be randomly assigned to ADRC treatment or active control arms in a 2:1 ratio and will be followed up for 6 months. The goal of the RC-004 study is to enroll all patients that were enrolled and treated in RC-002 and follow for 3 years.

Key Details

Gender

All

Age Range

30 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

246

Start Date

2022-01-01

Completion Date

2025-12-30

Last Updated

2025-08-17

Healthy Volunteers

No

Interventions

DEVICE

Adipose Derived Regenerative Cells

single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear

DEVICE

Corticosteroid

a single corticosteroid injection into the associated subacromial space

Locations (11)

Arizona Research Center

Phoenix, Arizona, United States

Biosolutions Clinical Research Center

La Mesa, California, United States

Lotus Clinical Research, LLC

Pasadena, California, United States

Sports and Orthopedic Center

Coral Springs, Florida, United States

Universal Axon Clinical Research

Doral, Florida, United States

Andrews Institute for Orthopedics and Sports Medicine

Gulf Breeze, Florida, United States

Georgia Institute for Clinical Research

Marietta, Georgia, United States

Tulane University School of Medicine

New Orleans, Louisiana, United States

Sanford Orthopedic Clinic/Research

Sioux Falls, South Dakota, United States

HD Research

Houston, Texas, United States

Texas Center for Cell Therapy and Research

San Antonio, Texas, United States