Partial Thickness Rotator Cuff TearNCT05400798
A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
A study testing Adipose Derived Regenerative Cells and Corticosteroid in people with Partial Thickness Rotator Cuff Tear, run by InGeneron, Inc. at 11 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Partial Thickness Rotator Cuff Tear
- What is being tested?
- Adipose Derived Regenerative Cells and Corticosteroid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Jan 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects must have completed RC-002.
- 2. Subjects can give appropriate consent.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites
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
HD Research
Houston, Texas, 77041
Biosolutions Clinical Research Center
La Mesa, California, 91942
Georgia Institute for Clinical Research
Marietta, Georgia, 30060
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Lotus Clinical Research, LLC
Pasadena, California, 91105
Arizona Research Center
Phoenix, Arizona, 85053
Texas Center for Cell Therapy and Research
San Antonio, Texas, 78240
Sanford Orthopedic Clinic/Research
Sioux Falls, South Dakota, 57104
About this study
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.
- Conditions
- Partial Thickness Rotator Cuff Tear
- Being tested
- Adipose Derived Regenerative Cells, Corticosteroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose Derived Regenerative CellsDevice
single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
CorticosteroidDevice
a single corticosteroid injection into the associated subacromial space
| Study group | Role | What they receive |
|---|---|---|
| Adipose Derived Regenerative Cells | Experimental | a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear Receives: Device: Adipose Derived Regenerative Cells |
| Corticosteroid | Active comparator | a single corticosteroid injection into the subacromial space of the index arm Receives: Device: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint- Safety
Incidence (%) severity and seriousness of adverse events (AEs)
Measured: 12 months
Primary Endpoint- Safety
Incidence (%) of treatment-related adverse events
Measured: 12 months
Secondary outcomes (4)
Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline
Measured: 12 months
Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline
Measured: 12 months
Mean improvement in VAS - Pain score compared to baseline
Measured: 12 months
Mean improvement in WORC score compared to baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Jan 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Thickness Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InGeneron, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Alt, MD, Study director, InGeneron, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400798
- Sponsor's protocol ID
- RC-004
- Status last verified
- Aug 2025
- First submitted
- 27 May 2022
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT05400798
- Acronym / sponsor ID
- RC-004
- Conditions
- Partial Thickness Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- InGeneron, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adipose Derived Regenerative Cells | Experimental | Device: Adipose Derived Regenerative Cellsa single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear |
| Corticosteroid | Active comparator | Device: Corticosteroida single corticosteroid injection into the subacromial space of the index arm |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Subjects must have completed RC-002.
- 2. Subjects can give appropriate consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose Derived Regenerative Cellssingle injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear | Device | Adipose Derived Regenerative Cells |
| Corticosteroida single corticosteroid injection into the associated subacromial space | Device | Corticosteroid |
Primary outcome
Primary Endpoint- Safety
Time frame: 12 months
Incidence (%) severity and seriousness of adverse events (AEs)
Primary Endpoint- Safety
Time frame: 12 months
Incidence (%) of treatment-related adverse events
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Alt, MD study director
InGeneron, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adipose Derived Regenerative Cells and Corticosteroid in people with Partial Thickness Rotator Cuff Tear, run by InGeneron, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint- Safety (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.