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ACTIVE NOT RECRUITING
NCT03752827
NA

Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears

Sponsor: InGeneron, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space.

Official title: A Prospective, Double-Blinded, Multi-Center Pivotal Trial of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears

Key Details

Gender

All

Age Range

30 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2019-05-13

Completion Date

2025-12

Last Updated

2025-08-20

Healthy Volunteers

Yes

Interventions

DEVICE

Adipose Derived Regenerative Cells

Adipose-derived regenerative cells isolated with the Transpose Ultra system

DRUG

Corticosteroid

Corticosteroid injection into subacrominal space

Locations (14)

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

Shrock Clinical Research

Fort Lauderdale, Florida, United States

Andrews Institute for Orthopaedics 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

University of Michigan

Ann Arbor, Michigan, United States

Sanford Medical Center

Fargo, North Dakota, United States

Sanford Orthopedic Clinic/Research

Sioux Falls, South Dakota, United States

HD Research

Houston, Texas, United States

Texas Plastic Surgery

San Antonio, Texas, United States