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

Conditions

• Partial Thickness Rotator Cuff Tear

Eligibility Criteria

Sex

ALL

Age

30 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Jan 1, 2022

Status verified

Aug 2025

Primary completion

Sep 30, 2025

Completion

Dec 30, 2025

Study Design

Enrollment

246 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

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

Primary Outcome Measure

Primary Endpoint- Safety [ Time Frame: 12 months ]

Locations (11)

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