A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
NCT ID: NCT05400798
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
246 participants
INTERVENTIONAL
2022-01-01
2025-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis.
NCT01739504
Effectiveness and Safety of Autologous ADRC for Treatment of Anterior Cruciate Ligament Partial Rupture
NCT02469792
Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
NCT04238143
Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis
NCT05005000
Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints
NCT03166410
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adipose Derived Regenerative Cells
a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
Adipose Derived Regenerative Cells
single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
Corticosteroid
a single corticosteroid injection into the subacromial space of the index arm
Corticosteroid
a single corticosteroid injection into the associated subacromial space
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Adipose Derived Regenerative Cells
single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
Corticosteroid
a single corticosteroid injection into the associated subacromial space
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 2\. Subjects can give appropriate consent.
Exclusion Criteria
* 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.
30 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
InGeneron, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christopher Alt, MD
Role: STUDY_DIRECTOR
InGeneron, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Research Center
Phoenix, Arizona, United States
Biosolutions Clinical Research Center
La Mesa, California, United States
Lotus Clinical Research, LLC
Pasadena, California, United States
Sports and Orthopedic Center
Coral Springs, Florida, United States
Universal Axon Clinical Research
Doral, Florida, United States
Andrews Institute for Orthopedics and Sports Medicine
Gulf Breeze, Florida, United States
Georgia Institute for Clinical Research
Marietta, Georgia, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Sanford Orthopedic Clinic/Research
Sioux Falls, South Dakota, United States
HD Research
Houston, Texas, United States
Texas Center for Cell Therapy and Research
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.