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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Partial Thickness Rotator Cuff Tear
• Intervention / Treatment: Device: Adipose Derived Regenerative Cells; Device: Corticosteroid

• Study Type: Interventional
• Enrollment (Estimated): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Arizona Research Center
  • California
    • La Mesa, California, United States, 91942
      • BioSolutions Clinical Research Center
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research, LLC
  • Florida
    • Coral Springs, Florida, United States, 33067
      • Sports and Orthopedic Center
    • Doral, Florida, United States, 33166
      • Universal Axon Clinical Research
    • Gulf Breeze, Florida, United States, 32561
      • Andrews Institute for Orthopedics and Sports Medicine
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Georgia Institute for Clinical Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Orthopedic Clinic/Research
  • Texas
    • Houston, Texas, United States, 77041
      • HD Research
    • San Antonio, Texas, United States, 78240
      • Texas Center for Cell Therapy and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Subjects must have completed RC-002.
• 2. Subjects can give appropriate consent.

Exclusion Criteria:

• 1. Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane.
• 2. Subjects whose pain behavior or pain medication usage is, in the opinion of the Investigator, out of proportion to the underlying clinical condition or could interfere with the study-required assessments.
• 3. Subject is on an active regimen of chemotherapy or radiation-based treatment.
• 4. Subject is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
• 5. Uncooperative subjects or those with neurological/psychiatric disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adipose Derived Regenerative Cells; a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear	Device: Adipose Derived Regenerative Cells; single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
Active Comparator: Corticosteroid; a single corticosteroid injection into the subacromial space of the index arm	Device: Corticosteroid; a single corticosteroid injection into the associated subacromial space

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint- Safety	Incidence (%) severity and seriousness of adverse events (AEs)	12 months
Primary Endpoint- Safety	Incidence (%) of treatment-related adverse events	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline	12 months
Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline	12 months
Mean improvement in VAS - Pain score compared to baseline	12 months
Mean improvement in WORC score compared to baseline	12 months

Collaborators and Investigators

• Sponsor: InGeneron, Inc.
• Investigators: Study Director: Christopher Alt, MD, InGeneron, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: RC-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No