Rotator Cuff TearNCT03752827
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 Rotator Cuff Tear and Rotator Cuff Tendinitis, run by InGeneron, Inc. at 14 sites in United States.
Trial summary
The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear, Rotator Cuff Tendinitis
- 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
- 168 participants
- Where
- 14 sitesUnited States
- Study dates
- 13 May 2019to 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 30-75 years of age (inclusive).
- Subjects have a minimum of three (3) months of clinical symptoms consistent with a partial-thickness rotator cuff tear including but not limited to pain, muscle weakness, or limited active range of motion (AROM).
- Subjects have > 70% passive range of motion (PROM) of the index shoulder.
- Subjects have a baseline VAS - Pain score of ≥ 30 mm.
- Subjects have a partial-thickness rotator cuff tear, defined as ≥25% partial-thickness tear of the supraspinatus tendon on a 1.5 Tesla (1.5T) or a 3 Tesla (3T) MRI within the last 3 months, as determined by the Investigator.
- Subjects can give appropriate consent.
Who cannot join
- Age < 30 or > 75.
- Subject has an insufficient amount of subcutaneous tissue to allow recovery of 100 milliliters (mL) of adipose tissue.
- Subjects who have received a corticosteroid injection in the index subacromial bursa within the last 3 months.
- Subjects who have received more than one (1) previous corticosteroid injections or any biologic treatment in the index subacromial bursa within the past 6 months.
- Subjects with severe arthrosis of the glenohumeral or acromioclavicular joint.
- Subjects with a full-thickness tear of the rotator cuff.
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- Subjects who have undergone major surgery on the affected shoulder meeting one of the following criteria:
- Performed as treatment for (or required manipulation of) the rotator cuff. Examples include, but are not limited to, subacromial decompression, rotator cuff repair, SLAP repair, arthroplasty and fracture fixation with implants that involve or penetrate the rotator cuff; OR
- Performed using implants that interfere with MR visualization and/or evaluation of the supraspinatus tendon (e.g., biceps tenodesis); OR
- Performed in/on the glenohumeral joint, subacromial space, or acromioclavicular joint within the last 3 years (e.g. soft tissue Bankart repairs performed >3 years ago may still qualify).
- NOTE: This exclusion criterion does not apply to minor soft tissue procedures with short recovery periods that do not involve musculoskeletal structures (e.g., lipoma excision).
- Subjects who were diagnosed with or treated for adhesive capsulitis of the index shoulder within the last 5 years.
- Subjects with current cervical radiculopathy impacting the index shoulder.
- Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane.
- Subjects with any contraindication to MRI scan according to MRI guidelines, or who are unwilling to undergo MRI procedures.
- 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.
- Subjects with a history of systemic malignant neoplasms within the last 5 years.
- Subjects with biopsy-proven, malignant or local neoplasm within the last 6 months or any history of local neoplasm at the site of administration (on the affected arm), excluding basal cell carcinoma.
- Subject is receiving immunosuppressant therapy or has a known immunologic or severe autoimmune disease that requires chronic systemic immunosuppressive or immunomodulatory therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, etc.). [Note: Topical or inhaled corticosteroids are permitted.]
- Subject is on an active regimen of chemotherapy or radiation- based treatment.
- Subjects with an allergy to sodium citrate or any "caine" type of local anesthetic.
- Subject is pregnant or breastfeeding or plans to become pregnant in the next 12 months.
- Subjects with clinically significant abnormal Lab tests (i.e. basic metabolic panel (BMP) or equivalent (e.g. CHEM-7), complete blood count (CBC), Liver function tests (LFTs), and prothrombin time/international normalized ratio (PT/INR)) as interpreted by the Investigator.
- 21. Subjects with a history of a bleeding diathesis or coagulopathy
- 22. Subject is, in the opinion of the Investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. Examples include the inability of the subject to complete patient-reported outcome instruments (PROs) and the inability of the Investigator to perform the injection procedure properly because of anatomic limitations of the subject.
- 23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. (Noninterventional observational studies are not exclusionary.)
- 24. Subject 1) is a litigant in a civil suit that could affect the subject's ability to complete the study related activities or 2) is a defendant in a criminal case or 3) has an active workman's compensation case in progress.
- 25. 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.
- 26. 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
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Michigan
Ann Arbor, Michigan, 48105
Sports and Orthopedic Center
Coral Springs, Florida, 33067
Universal Axon Clinical Research
Doral, Florida, 33166
Sanford Medical Center
Fargo, North Dakota, 58103
Shrock Clinical Research
Fort Lauderdale, Florida, 33316
Andrews Institute for Orthopaedics 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 Plastic Surgery
San Antonio, Texas, 78240
Sanford Orthopedic Clinic/Research
Sioux Falls, South Dakota, 57104
About this study
Official title: A Prospective, Double-Blinded, Multi-Center Pivotal Trial of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space.
Read the detailed description
This is a prospective, double-blinded, randomized, active-controlled, multi-site, pivotal safety and superior effectiveness study in patients with symptomatic partial-thickness rotator cuff tears comparing a single ADRC injection generated with the Transpose® RT system into the supraspinatus tendon and surrounding area to standard-of-care (SOC) corticosteroid injection into the subacromial bursa.
Up to 20 U.S. centers will be initiated to enroll in the study. 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.
- Conditions
- Rotator Cuff Tear, Rotator Cuff Tendinitis
- Being tested
- Adipose Derived Regenerative Cells, Corticosteroid
- Keywords
- rotator cuff tear, adipose-derived regenerative cells, adipose-derived stem cells, partial rotator cuff tears, corticosteroid
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose Derived Regenerative CellsDevice
Adipose-derived regenerative cells isolated with the Transpose Ultra system
CorticosteroidDrug
Corticosteroid injection into subacrominal space
| Study group | Role | What they receive |
|---|---|---|
| Adipose Derived Regenerative Cells | Experimental | Adipose-derived regenerative cell injection into the area of the supraspinatus tendon tear Receives: Device: Adipose Derived Regenerative Cells |
| Corticosteroid | Active comparator | Subjects in the active control arm will receive a corticosteroid injection into the subacromial space using ultrasound (US) guidance. Receives: Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Pain: VAS
≥ 14-millimeter (mm) improvement in Visual Analog Scale (VAS)
Measured: 24 weeks
Improvement or no worsening in supraspinatus strength
supraspinatus strength on the MRC Muscle Scale compared to baseline For supraspinatus strength on the MRC Muscle Scale compared to baseline
- For subjects with normal supraspinatus strength (MRC Muscle Scale = 5] at baseline: no worsening in supraspinatus strength on the MRC Muscle Scale compared to baseline
Measured: 24 weeks
Secondary outcomes (5)
Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS
Pain score compared to baseline at 24 weeks
Measured: 24 weeks
Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale
Supraspinatus strength on the MRC Muscle Scale compared to baseline at 24 weeks
Measured: 24 weeks
Mean improvement in VAS - Pain score
VAS pain score compared to baseline
Measured: 12 and 24 weeks
Mean improvement in WORC score
WORC score compared to baseline
Measured: 12 and 24 weeks
Percentage of subjects who demonstrate a ≥ 1-grade improvement in supraspinatus strength on the MRC Muscle Scale
Supraspinatus strength on the MRC Muscle Scale compared to baseline at 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start13 May 2019
- Primary completion30 Nov 2023
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- InGeneron, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752827
- Sponsor's protocol ID
- RC-002
- Status last verified
- Aug 2025
- First submitted
- 20 Nov 2018
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-Blinded, Multi-Center Pivotal Trial of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT03752827
- Acronym / sponsor ID
- RC-002
- Conditions
- Rotator Cuff Tear, Rotator Cuff Tendinitis
- Keywords
- rotator cuff tear, adipose-derived regenerative cells, adipose-derived stem cells, partial rotator cuff tears, corticosteroid
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 168 participants (actual)
- Lead sponsor
- InGeneron, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 May 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Nov 2018 (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.
The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space.
Detailed description
This is a prospective, double-blinded, randomized, active-controlled, multi-site, pivotal safety and superior effectiveness study in patients with symptomatic partial-thickness rotator cuff tears comparing a single ADRC injection generated with the Transpose® RT system into the supraspinatus tendon and surrounding area to standard-of-care (SOC) corticosteroid injection into the subacromial bursa.
Up to 20 U.S. centers will be initiated to enroll in the study. 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.
Study design
- Primary purpose
- Treatment
- 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 CellsAdipose-derived regenerative cell injection into the area of the supraspinatus tendon tear |
| Corticosteroid | Active comparator | Drug: CorticosteroidSubjects in the active control arm will receive a corticosteroid injection into the subacromial space using ultrasound (US) guidance. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females 30-75 years of age (inclusive).
- Subjects have a minimum of three (3) months of clinical symptoms consistent with a partial-thickness rotator cuff tear including but not limited to pain, muscle weakness, or limited active range of motion (AROM).
- Subjects have > 70% passive range of motion (PROM) of the index shoulder.
- Subjects have a baseline VAS - Pain score of ≥ 30 mm.
- Subjects have a partial-thickness rotator cuff tear, defined as ≥25% partial-thickness tear of the supraspinatus tendon on a 1.5 Tesla (1.5T) or a 3 Tesla (3T) MRI within the last 3 months, as determined by the Investigator.
Key exclusion criteria (29 listed)
- Age < 30 or > 75.
- Subject has an insufficient amount of subcutaneous tissue to allow recovery of 100 milliliters (mL) of adipose tissue.
- Subjects who have received a corticosteroid injection in the index subacromial bursa within the last 3 months.
- Subjects who have received more than one (1) previous corticosteroid injections or any biologic treatment in the index subacromial bursa within the past 6 months.
- Subjects with severe arthrosis of the glenohumeral or acromioclavicular joint.
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 CellsAdipose-derived regenerative cells isolated with the Transpose Ultra system | Device | Adipose Derived Regenerative Cells |
| CorticosteroidCorticosteroid injection into subacrominal space | Drug | Corticosteroid |
Primary outcome
Improvement in Pain: VAS
Time frame: 24 weeks
≥ 14-millimeter (mm) improvement in Visual Analog Scale (VAS)
Improvement or no worsening in supraspinatus strength
Time frame: 24 weeks
supraspinatus strength on the MRC Muscle Scale compared to baseline For supraspinatus strength on the MRC Muscle Scale compared to baseline • For subjects with normal supraspinatus strength (MRC Muscle Scale = 5] at baseline: no worsening in supraspinatus strength on the MRC Muscle Scale compared to baseline
5 secondary outcomes
Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS
Time frame: 24 weeks
Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale
Time frame: 24 weeks
Mean improvement in VAS - Pain score
Time frame: 12 and 24 weeks
Mean improvement in WORC score
Time frame: 12 and 24 weeks
Percentage of subjects who demonstrate a ≥ 1-grade improvement in supraspinatus strength on the MRC Muscle Scale
Time frame: 24 weeks
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 20 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 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 Rotator Cuff Tear and Rotator Cuff Tendinitis, run by InGeneron, Inc. at 14 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 6 inclusion and 29 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: under way, not looking for participants, as of the sponsor's last update on 20 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 14 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?
Improvement in Pain: VAS (time frame: 24 weeks). 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 20 Aug 2025.