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

NCT05400798 | Enrolling By Invitation FDA Device

• 1 other identifier: RC-004
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 11

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Adipose Derived Regenerative Cells

EXPERIMENTAL

a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear

Device: Adipose Derived Regenerative Cells

Corticosteroid

ACTIVE COMPARATOR

a single corticosteroid injection into the subacromial space of the index arm

Device: Corticosteroid

Interventions

Adipose Derived Regenerative Cells DEVICE

single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear

Adipose Derived Regenerative Cells

Corticosteroid DEVICE

a single corticosteroid injection into the associated subacromial space

Corticosteroid

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane.
• \. 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.
• \. Subject is on an active regimen of chemotherapy or radiation-based treatment.
• \. 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.
• \. 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.

Sponsors & Collaborators

• InGeneron, Inc.: lead

Study Sites (11)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Biosolutions Clinical Research Center

La Mesa, California, 91942, United States

Location

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

Sports and Orthopedic Center

Coral Springs, Florida, 33067, United States

Location

Universal Axon Clinical Research

Doral, Florida, 33166, United States

Location

Andrews Institute for Orthopedics and Sports Medicine

Gulf Breeze, Florida, 32561, United States

Location

Georgia Institute for Clinical Research

Marietta, Georgia, 30060, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Sanford Orthopedic Clinic/Research

Sioux Falls, South Dakota, 57104, United States

Location

HD Research

Houston, Texas, 77041, United States

Location

Texas Center for Cell Therapy and Research

San Antonio, Texas, 78240, United States

Location

Study Officials

• Christopher Alt, MD

  InGeneron, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 2, 2022
• Study Start: January 1, 2022
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)