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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

246

Participants

Timeline

Start Date

January 1, 2022

Primary Completion Date

September 30, 2025

Study Completion Date

December 30, 2025

Conditions
Partial Thickness Rotator Cuff Tear
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

Trial Locations (11)

30060

Georgia Institute for Clinical Research, Marietta

32561

Andrews Institute for Orthopedics and Sports Medicine, Gulf Breeze

33067

Sports and Orthopedic Center, Coral Springs

33166

Universal Axon Clinical Research, Doral

57104

Sanford Orthopedic Clinic/Research, Sioux Falls

70112

Tulane University School of Medicine, New Orleans

77041

HD Research, Houston

78240

Texas Center for Cell Therapy and Research, San Antonio

85053

Arizona Research Center, Phoenix

91105

Lotus Clinical Research, LLC, Pasadena

91942

Biosolutions Clinical Research Center, La Mesa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

InGeneron, Inc.

INDUSTRY