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

Not Applicable

• Conditions: Partial Thickness Rotator Cuff Tear
• Interventions: Device: Corticosteroid; Device: Adipose Derived Regenerative Cells

• Registration Number: NCT05400798
• Lead Sponsor: InGeneron, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-06-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2025-03-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 246

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid	Corticosteroid	a single corticosteroid injection into the subacromial space of the index arm
Adipose Derived Regenerative Cells	Adipose Derived Regenerative Cells	a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear

Primary Outcome Measures

Name	Time	Method
Primary Endpoint- Safety	12 months	Incidence (%) of treatment-related adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (11)

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Biosolutions Clinical Research Center; 🇺🇸 La Mesa, California, United States

Lotus Clinical Research, LLC; 🇺🇸 Pasadena, California, United States

Sports and Orthopedic Center; 🇺🇸 Coral Springs, Florida, United States

Andrews Institute for Orthopedics and Sports Medicine; 🇺🇸 Gulf Breeze, Florida, United States

Universal Axon Clinical Research; 🇺🇸 Doral, Florida, United States

Georgia Institute for Clinical Research; 🇺🇸 Marietta, Georgia, United States

Texas Center for Cell Therapy and Research; 🇺🇸 San Antonio, Texas, United States

Sanford Orthopedic Clinic/Research; 🇺🇸 Sioux Falls, South Dakota, United States

Tulane University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

HD Research; 🇺🇸 Houston, Texas, United States