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

Rotator Cuff Tear Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03752827
• Other study ID #: RC-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: InGeneron, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 compared to the administration of a single corticosteroid injection into the associated subacromial space.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: June 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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 1.5 Tesla (1.5T) or 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), excluding basal cell carcinoma.

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear
• Rotator Cuff Tendinitis
• Tendinopathy

Intervention

Device:
• Adipose Derived Regenerative Cells
Adipose-derived regenerative cells isolated with the Transpose Ultra system

Drug:
• Corticosteroid
Corticosteroid injection into subacrominal space

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Sports and Orthopedic Center	Coral Springs	Florida
United States	Universal Axon Clinical Research	Doral	Florida
United States	Sanford Medical Center	Fargo	North Dakota
United States	Shrock Clinical Research	Fort Lauderdale	Florida
United States	Andrews Institute for Orthopaedics and Sports Medicine	Gulf Breeze	Florida
United States	HD Research	Houston	Texas
United States	Biosolutions Clinical Research Center	La Mesa	California
United States	Georgia Institute for Clinical Research	Marietta	Georgia
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Lotus Clinical Research, LLC	Pasadena	California
United States	Arizona Research Center	Phoenix	Arizona
United States	Texas Plastic Surgery	San Antonio	Texas
United States	Sanford Orthopedic Clinic/Research	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
InGeneron, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean improvement in Rand Short Form-36 score	Rand Form-36 score compared at baseline	24 weeks
Other	Measurement of subject satisfaction with treatment on a VAS scale (VAS - Satisfaction)	VAS satisfaction score improvement	24 weeks
Other	Measurement of EuroQoL-5D-5L (EQ-5D-5L)	EuroQoL -5D-5L score	24 weeks
Other	Measurement of Shoulder Activity Level	Recording shoulder activity level	24 weeks
Other	Measurement of shoulder motion (forward elevation, shoulder abduction in the plane of the scapula)	As determined by goniometer	24 weeks
Primary	Improvement in Pain: VAS	= 14-millimeter (mm) improvement in Visual Analog Scale (VAS)	24 weeks
Primary	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	24 weeks
Secondary	Percentage of subjects who demonstrate = 14 mm improvement in VAS	Pain score compared to baseline at 24 weeks	24 weeks
Secondary	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	24 weeks
Secondary	Mean improvement in VAS - Pain score	VAS pain score compared to baseline	12 and 24 weeks
Secondary	Mean improvement in WORC score	WORC score compared to baseline	12 and 24 weeks
Secondary	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.	24 weeks