NCT03752827

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: InGeneron, Inc. · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a prospective, double-blinded, randomized, active-controlled, multi-site, pivotal safety and superior effectiveness study in patients with symptomatic partial-thickness rotator cuff tears comparing a single ADRC injection generated with the Transpose® RT system into the supraspinatus tendon and surrounding area to standard-of-care (SOC) corticosteroid injection into the subacromial bursa. Up to 20 U.S. centers will be initiated to enroll in the study. 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.

Conditions

• Rotator Cuff Tear
• Rotator Cuff Tendinitis

Interventions

Type	Name	Description
DEVICE	Adipose Derived Regenerative Cells	Adipose-derived regenerative cells isolated with the Transpose Ultra system
DRUG	Corticosteroid	Corticosteroid injection into subacrominal space

Timeline

• Start date: 2019-05-13
• Primary completion: 2023-11-30
• Completion: 2025-12-01
• First posted: 2018-11-26
• Last updated: 2025-08-20

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study