Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 30 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Males and females 30-75 years of age (inclusive). 2. 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).
3. Subjects have > 70% passive range of motion (PROM) of the index shoulder. 4. Subjects have a baseline VAS
  • - Pain score of ≥ 30 mm.
5. Subjects have a partial-thickness rotator cuff tear, defined as ≥25% partial-thickness tear of the supraspinatus tendon on a 3 Tesla (3T) MRI within the last 3 months, as determined by the Investigator. 6. Subjects can give appropriate consent.

Exclusion Criteria:

1. Age < 30 or > 75. 2. Subject has an insufficient amount of subcutaneous tissue to allow recovery of 100 milliliters (mL) of adipose tissue. 3. Subjects who have received a corticosteroid injection in the index subacromial bursa within the last 3 months. 4. 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.
5. Subjects with severe arthrosis of the glenohumeral or acromioclavicular joint. 6. Subjects with a full-thickness tear of the rotator cuff. 7. 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). 8. Subjects who were diagnosed with or treated for adhesive capsulitis of the index shoulder within the last 5 years. 9. Subjects with current cervical radiculopathy impacting the index shoulder. 10. Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane. 11. Subjects with any contraindication to MRI scan according to MRI guidelines, or who are unwilling to undergo MRI procedures. 12. 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. 13. Subjects with a history of systemic malignant neoplasms within the last 5 years. 14. 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). 15. 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.] 16. Subject is on an active regimen of chemotherapy or radiation- based treatment. 17. Subjects with an allergy to sodium citrate or any "caine" type of local anesthetic. 18. Subject is pregnant or breastfeeding or plans to become pregnant in the next 12 months. 19. 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03752827
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

InGeneron, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jason Hurd, MD
Principal Investigator Affiliation Sanford Orthopedics & Sports Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rotator Cuff Tear, Rotator Cuff Tendinitis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Adipose Derived Regenerative Cells

Adipose-derived regenerative cell injection into the area of the supraspinatus tendon tear

Active Comparator: Corticosteroid

Subjects in the active control arm will receive a corticosteroid injection into the subacromial space using ultrasound (US) guidance.

Interventions

Device: - Adipose Derived Regenerative Cells

Adipose-derived regenerative cells isolated with the Transpose Ultra system

Drug: - Corticosteroid

Corticosteroid injection into subacrominal space

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arizona Research Center, Phoenix, Arizona

Status

Recruiting

Address

Arizona Research Center

Phoenix, Arizona, 85053

Site Contact

Rachel Gledhill

[email protected]

(713) 440 9900

Biosolution research, La Mesa, California

Status

Recruiting

Address

Biosolution research

La Mesa, California, 91942

Site Contact

Tamara Tamara Packard

[email protected]

(713) 440 9900

Lotus Clinical Research, LLC, Pasadena, California

Status

Recruiting

Address

Lotus Clinical Research, LLC

Pasadena, California, 91105

Site Contact

Nick Sargsyan

[email protected]

(713) 440 9900

Sports and Orthopedic Center, Coral Springs, Florida

Status

Recruiting

Address

Sports and Orthopedic Center

Coral Springs, Florida, 33067

Site Contact

Danahe Navarrete

[email protected]

(713) 440 9900

Universal Axon Clinical Research, Doral, Florida

Status

Recruiting

Address

Universal Axon Clinical Research

Doral, Florida, 33166

Site Contact

Angel Benitez

[email protected]

(713) 440 9900

Georgia Institute for Clinical Research, Marietta, Georgia

Status

Recruiting

Address

Georgia Institute for Clinical Research

Marietta, Georgia, 30060

Site Contact

Octavia Nichols

[email protected]

(713) 440 9900

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48105

Site Contact

Jordyn Sessel

[email protected]

(713) 440 9900

New Jersey Regenerative Institute, Cedar Knolls, New Jersey

Status

Recruiting

Address

New Jersey Regenerative Institute

Cedar Knolls, New Jersey, 07927

Site Contact

Katrina Norlander

[email protected]

(713) 440 9900

Sanford Medical Center, Fargo, North Dakota

Status

Recruiting

Address

Sanford Medical Center

Fargo, North Dakota, 58103

Sanford Orthopedic Clinic/Research, Sioux Falls, South Dakota

Status

Recruiting

Address

Sanford Orthopedic Clinic/Research

Sioux Falls, South Dakota, 57104

HD Research, Houston, Texas

Status

Recruiting

Address

HD Research

Houston, Texas, 77041

Site Contact

Hector Hector Garcia Chavez

[email protected]

(713) 440 9900