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

Overview

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.

Interventions

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

Primary outcome measures

• Primary Endpoint- Safety [Time frame: 12 months]
• Primary Endpoint- Safety [Time frame: 12 months]

Secondary outcome measures (4)

• Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline [Time frame: 12 months]
• Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline [Time frame: 12 months]
• Mean improvement in VAS - Pain score compared to baseline [Time frame: 12 months]
• Mean improvement in WORC score compared to baseline [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Other

Study locations

United States · 11 centers

• Arizona Research Center — Phoenix
• Biosolutions Clinical Research Center — La Mesa
• Lotus Clinical Research, LLC — Pasadena
• Sports and Orthopedic Center — Coral Springs
• Universal Axon Clinical Research — Doral
• Andrews Institute for Orthopedics and Sports Medicine — Gulf Breeze
• Georgia Institute for Clinical Research — Marietta
• Tulane University School of Medicine — New Orleans
• … and 3 more centers

Identifiers

NCT: NCT05400798 · RC-004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗