A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
Public ClinicalTrials.gov record NCT05400798. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05400798
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 246 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 1, 2022 (Actual)
- Primary completion
- Sep 30, 2025 (Estimated)
- Completion
- Dec 30, 2025 (Estimated)
- Last update posted
- Aug 17, 2025
2022 – 2025
United States locations
- U.S. sites
- 11
- U.S. states
- 7
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85053 | — |
| Biosolutions Clinical Research Center | La Mesa | California | 91942 | — |
| Lotus Clinical Research, LLC | Pasadena | California | 91105 | — |
| Sports and Orthopedic Center | Coral Springs | Florida | 33067 | — |
| Universal Axon Clinical Research | Doral | Florida | 33166 | — |
| Andrews Institute for Orthopedics and Sports Medicine | Gulf Breeze | Florida | 32561 | — |
| Georgia Institute for Clinical Research | Marietta | Georgia | 30060 | — |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | — |
| Sanford Orthopedic Clinic/Research | Sioux Falls | South Dakota | 57104 | — |
| HD Research | Houston | Texas | 77041 | — |
| Texas Center for Cell Therapy and Research | San Antonio | Texas | 78240 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05400798, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 17, 2025 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05400798 live on ClinicalTrials.gov.