NCT05400798

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: InGeneron, Inc. · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Partial Thickness Rotator Cuff Tear

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-09-30
• Completion: 2025-12-30
• First posted: 2022-06-02
• Last updated: 2025-08-17

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study