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

Primary Purpose

Rotator Cuff Tear, Rotator Cuff Tendinitis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adipose Derived Regenerative Cells
Corticosteroid
Sponsored by
InGeneron, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring rotator cuff tear, adipose-derived regenerative cells, adipose-derived stem cells, partial rotator cuff tears, corticosteroid

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Arizona Research Center
  • Biosolutions Clinical Research Center
  • Lotus Clinical Research, LLC
  • Sports and Orthopedic Center
  • Universal Axon Clinical Research
  • Shrock Clinical Research
  • Andrews Institute for Orthopaedics and Sports Medicine
  • Georgia Institute for Clinical Research
  • Tulane University School of Medicine
  • University of Michigan
  • Sanford Medical Center
  • Sanford Orthopedic Clinic/Research
  • HD Research
  • Texas Plastic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adipose Derived Regenerative Cells

Corticosteroid

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement in Pain: VAS
≥ 14-millimeter (mm) improvement in Visual Analog Scale (VAS)
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

Secondary Outcome Measures

Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS
Pain score compared to baseline at 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
Mean improvement in VAS - Pain score
VAS pain score compared to baseline
Mean improvement in WORC score
WORC score compared to baseline
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.

Full Information

First Posted
November 20, 2018
Last Updated
September 26, 2023
Sponsor
InGeneron, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03752827
Brief Title
Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InGeneron, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear, Rotator Cuff Tendinitis
Keywords
rotator cuff tear, adipose-derived regenerative cells, adipose-derived stem cells, partial rotator cuff tears, corticosteroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
It is a double-blinded trial in which the subject, post-procedural investigator and imaging core laboratory radiologists are blinded.
Allocation
Randomized
Enrollment
246 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adipose Derived Regenerative Cells
Arm Type
Experimental
Arm Description
Adipose-derived regenerative cell injection into the area of the supraspinatus tendon tear
Arm Title
Corticosteroid
Arm Type
Active Comparator
Arm Description
Subjects in the active control arm will receive a corticosteroid injection into the subacromial space using ultrasound (US) guidance.
Intervention Type
Device
Intervention Name(s)
Adipose Derived Regenerative Cells
Intervention Description
Adipose-derived regenerative cells isolated with the Transpose Ultra system
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Intervention Description
Corticosteroid injection into subacrominal space
Primary Outcome Measure Information:
Title
Improvement in Pain: VAS
Description
≥ 14-millimeter (mm) improvement in Visual Analog Scale (VAS)
Time Frame
24 weeks
Title
Improvement or no worsening in supraspinatus strength
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS
Description
Pain score compared to baseline at 24 weeks
Time Frame
24 weeks
Title
Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale
Description
Supraspinatus strength on the MRC Muscle Scale compared to baseline at 24 weeks
Time Frame
24 weeks
Title
Mean improvement in VAS - Pain score
Description
VAS pain score compared to baseline
Time Frame
12 and 24 weeks
Title
Mean improvement in WORC score
Description
WORC score compared to baseline
Time Frame
12 and 24 weeks
Title
Percentage of subjects who demonstrate a ≥ 1-grade improvement in supraspinatus strength on the MRC Muscle Scale
Description
Supraspinatus strength on the MRC Muscle Scale compared to baseline at 24 weeks.
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Mean improvement in Rand Short Form-36 score
Description
Rand Form-36 score compared at baseline
Time Frame
24 weeks
Title
Measurement of subject satisfaction with treatment on a VAS scale (VAS - Satisfaction)
Description
VAS satisfaction score improvement
Time Frame
24 weeks
Title
Measurement of EuroQoL-5D-5L (EQ-5D-5L)
Description
EuroQoL -5D-5L score
Time Frame
24 weeks
Title
Measurement of Shoulder Activity Level
Description
Recording shoulder activity level
Time Frame
24 weeks
Title
Measurement of shoulder motion (forward elevation, shoulder abduction in the plane of the scapula)
Description
As determined by goniometer
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Biosolutions Clinical Research Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Lotus Clinical Research, LLC
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Sports and Orthopedic Center
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Universal Axon Clinical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Shrock Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Andrews Institute for Orthopaedics and Sports Medicine
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Georgia Institute for Clinical Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Sanford Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Sanford Orthopedic Clinic/Research
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
HD Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77041
Country
United States
Facility Name
Texas Plastic Surgery
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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