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

Partial Thickness Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05400798
• Other study ID #: RC-004
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: InGeneron, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 246
• Est. completion date: June 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Partial Thickness Rotator Cuff Tear
• Rotator Cuff Injuries

Intervention

Device:
• Adipose Derived Regenerative Cells
single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
• Corticosteroid
a single corticosteroid injection into the associated subacromial space

Locations

Country	Name	City	State
United States	Sports and Orthopedic Center	Coral Springs	Florida
United States	Universal Axon Clinical Research	Doral	Florida
United States	Andrews Institute for Orthopedics and Sports Medicine	Gulf Breeze	Florida
United States	HD Research	Houston	Texas
United States	Biosolutions Clinical Research Center	La Mesa	California
United States	Georgia Institute for Clinical Research	Marietta	Georgia
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Lotus Clinical Research, LLC	Pasadena	California
United States	Arizona Research Center	Phoenix	Arizona
United States	Texas Center for Cell Therapy and Research	San Antonio	Texas
United States	Sanford Orthopedic Clinic/Research	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
InGeneron, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint- Safety	Incidence (%) severity and seriousness of adverse events (AEs)	12 months
Primary	Primary Endpoint- Safety	Incidence (%) of treatment-related adverse events	12 months
Secondary	Percentage of subjects who demonstrate = 14 mm improvement in VAS - Pain score compared to baseline		12 months
Secondary	Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline		12 months
Secondary	Mean improvement in VAS - Pain score compared to baseline		12 months
Secondary	Mean improvement in WORC score compared to baseline		12 months