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

NCT05400798 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2025-08-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • InGeneron, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Alt, MD · InGeneron, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2025-09-30
Completion
2025-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05400798 on ClinicalTrials.gov