A Prospective, Double-Blinded, Multi-Center Pivotal Trial of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears

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

Sponsors

Lead sponsor: InGeneron, Inc.

Source InGeneron, Inc.
Brief 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 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.

Overall Status Recruiting
Start Date May 13, 2019
Completion Date November 1, 2020
Primary Completion Date September 15, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Improvement in Pain: VAS 48 weeks
Improvement or no worsening in supraspinatus strength 48 weeks
Secondary Outcome
Measure Time Frame
Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS 24 weeks
Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale 24 weeks
Mean improvement in VAS - Pain score 48 weeks
Mean improvement in WORC score 24 weeks
Percentage of subjects who demonstrate an improvement in MRI-assessed supraspinatus tendon tear status 24 weeks
Percentage of subjects who demonstrate a ≥ 1-grade improvement in supraspinatus strength on the MRC Muscle Scale 24 weeks
Enrollment 246
Condition
Intervention

Intervention type: Device

Intervention name: Adipose Derived Regenerative Cells

Description: Adipose-derived regenerative cells isolated with the Transpose Ultra system

Arm group label: Adipose Derived Regenerative Cells

Intervention type: Drug

Intervention name: Corticosteroid

Description: Corticosteroid injection into subacrominal space

Arm group label: Corticosteroid

Eligibility

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.

Gender: All

Minimum age: 30 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Jason Hurd, MD Principal Investigator Sanford Orthopedics & Sports Medicine
Overall Contact

Last name: Deborah Quigley

Phone: 508-446-0266

Email: [email protected]

Location
facility status contact investigator
Arizona Research Center | Phoenix, Arizona, 85053, United States Recruiting Rachel Gledhill [email protected] Joseph Gimbel, MD Principal Investigator
Biosolution research | La Mesa, California, 91942, United States Recruiting Tamara Tamara Packard [email protected] Peter Hanson, MD Principal Investigator
Lotus Clinical Research, LLC | Pasadena, California, 91105, United States Recruiting Nick Sargsyan [email protected] Alina Beaton, MD Principal Investigator
Sports and Orthopedic Center | Coral Springs, Florida, 33067, United States Recruiting Danahe Navarrete [email protected]
Universal Axon Clinical Research | Doral, Florida, 33166, United States Recruiting Angel Benitez [email protected] Luis Martinez, MD Principal Investigator
Georgia Institute for Clinical Research | Marietta, Georgia, 30060, United States Recruiting Octavia Nichols [email protected] Anthony Grasso, MD Principal Investigator
University of Michigan | Ann Arbor, Michigan, 48105, United States Recruiting Jordyn Sessel [email protected] Tariq Awan, MD Principal Investigator
New Jersey Regenerative Institute | Cedar Knolls, New Jersey, 07927, United States Recruiting Katrina Norlander [email protected] Gerard Malanga, MD Principal Investigator
Sanford Medical Center | Fargo, North Dakota, 58103, United States Recruiting Amy Tuchscherer [email protected] Mark Lundeen, MD Principal Investigator
Sanford Orthopedic Clinic/Research | Sioux Falls, South Dakota, 57104, United States Recruiting Kristen Walsh [email protected] Jason Hurd, MD Principal Investigator
HD Research | Houston, Texas, 77041, United States Recruiting Hector Hector Garcia Chavez [email protected] Solanki, MD Principal Investigator
Location Countries

United States

Verification Date

February 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Adipose Derived Regenerative Cells

Arm group type: Experimental

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

Arm group label: Corticosteroid

Arm group type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking description: It is a double-blinded trial in which the subject, post-procedural investigator and imaging core laboratory radiologists are blinded.

Source: ClinicalTrials.gov