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

Last updated: April 4, 2024
Sponsor: InGeneron, Inc.
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

Adipose Derived Regenerative Cells

Corticosteroid

Clinical Study ID

NCT05400798
RC-004
  • Ages 30-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 246
Treatment Group(s): 2
Primary Treatment: Adipose Derived Regenerative Cells
Phase:
Study Start date:
January 01, 2022
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Arizona Research Center

    Phoenix, Arizona 85053
    United States

    Site Not Available

  • Biosolutions Clinical Research Center

    La Mesa, California 91942
    United States

    Site Not Available

  • Lotus Clinical Research, LLC

    Pasadena, California 91105
    United States

    Site Not Available

  • Sports and Orthopedic Center

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Universal Axon Clinical Research

    Doral, Florida 33166
    United States

    Site Not Available

  • Shrock Clinical Research

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Andrews Institute for Orthopedics and Sports Medicine

    Gulf Breeze, Florida 32561
    United States

    Site Not Available

  • Georgia Institute for Clinical Research

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Tulane University School of Medicine

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Sanford Medical Center

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Sanford Orthopedic Clinic/Research

    Sioux Falls, South Dakota 57104
    United States

    Site Not Available

  • HD Research

    Houston, Texas 77041
    United States

    Site Not Available

  • Texas Center for Cell Therapy and Research

    San Antonio, Texas 78240
    United States

    Site Not Available

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