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Enrolling by Invitation

NCT Number: NCT05400798

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.

Enrolling by Invitation

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Research Center, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adipose Derived Regenerative Cells

Device

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

Corticosteroid

Device

a single corticosteroid injection into the associated subacromial space

Primary outcomes

  1. Primary Endpoint- Safety

    Time frame: 12 months

    Incidence (%) severity and seriousness of adverse events (AEs)

  2. Primary Endpoint- Safety

    Time frame: 12 months

    Incidence (%) of treatment-related adverse events

Secondary outcomes

  1. Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline

    Time frame: 12 months

  2. Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline

    Time frame: 12 months

  3. Mean improvement in VAS - Pain score compared to baseline

    Time frame: 12 months

  4. Mean improvement in WORC score compared to baseline

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

InGeneron, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2022
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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