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

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ClinicalTrials.gov Identifier: NCT03752827
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Rotator Cuff Tendinitis Device: Adipose Derived Regenerative Cells Drug: Corticosteroid Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
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
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids Tears

Arm Intervention/treatment
Experimental: Adipose Derived Regenerative Cells
Adipose-derived regenerative cell injection into the area of the supraspinatus tendon tear
Device: Adipose Derived Regenerative Cells
Adipose-derived regenerative cells isolated with the Transpose Ultra system

Active Comparator: Corticosteroid
Subjects in the active control arm will receive a corticosteroid injection into the subacromial space using ultrasound (US) guidance.
Drug: Corticosteroid
Corticosteroid injection into subacrominal space




Primary Outcome Measures :
  1. Improvement in Pain: VAS [ Time Frame: 48 weeks ]
    ≥ 14-millimeter (mm) improvement in Visual Analog Scale (VAS)

  2. Improvement or no worsening in supraspinatus strength [ Time Frame: 48 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



Secondary Outcome Measures :
  1. Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS [ Time Frame: 24 weeks ]
    Pain score compared to baseline at 24 weeks

  2. Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale [ Time Frame: 24 weeks ]
    Supraspinatus strength on the MRC Muscle Scale compared to baseline at 24 weeks

  3. Mean improvement in VAS - Pain score [ Time Frame: 48 weeks ]
    VAS pain score compared to baseline

  4. Mean improvement in WORC score [ Time Frame: 24 weeks ]
    WORC score compared to baseline

  5. Percentage of subjects who demonstrate an improvement in MRI-assessed supraspinatus tendon tear status [ Time Frame: 24 weeks ]
    Percentage of subjects with improvement

  6. Percentage of subjects who demonstrate a ≥ 1-grade improvement in supraspinatus strength on the MRC Muscle Scale [ Time Frame: 24 weeks ]
    Supraspinatus strength on the MRC Muscle Scale compared to baseline at 24 weeks.


Other Outcome Measures:
  1. Mean improvement in Rand Short Form-36 score [ Time Frame: 48 weeks ]
    Rand Form-36 score compared at baseline

  2. Measurement of subject satisfaction with treatment on a VAS scale (VAS - Satisfaction) [ Time Frame: 48 weeks ]
    VAS satisfaction score improvement

  3. Measurement of EuroQoL-5D-5L (EQ-5D-5L) [ Time Frame: 24 weeks ]
    EuroQoL -5D-5L score

  4. Measurement of Shoulder Activity Level [ Time Frame: 24 weeks ]
    Recording shoulder activity level

  5. Measurement of shoulder motion (forward elevation, shoulder abduction in the plane of the scapula) [ Time Frame: 24 weeks ]
    As determined by goniometer

  6. MRI-assessed supraspinatus tendon tear location (articular surface, bursal surface, interstitial), tendon tear size and tendon tear percent thickness involvement [ Time Frame: 48 weeks ]
    tendon tear size and tendon thickness



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females 40-75 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 ≥50% 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 < 40 or > 75.
  2. Subject has an insufficient amount of subcutaneous tissue to allow recovery of 100 milliliters (mL) of lipoaspirate.
  3. Subjects who have received a corticosteroid injection in the index rotator cuff site within the last 3 months.
  4. Subjects who have received more than one (1) previous corticosteroid injections in the index rotator cuff site at any point in the past.
  5. Subjects with severe arthrosis of the glenohumeral or acromioclavicular joint.
  6. Subjects with a full-thickness tear of the rotator cuff.
  7. Subjects with any previous shoulder surgery on the affected shoulder.
  8. Subjects with a previous or current history of adhesive capsulitis of the index shoulder.
  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 immunosuppressive or immunomodulatory therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, etc.).
  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.
  20. Subjects with clinical evidence of an abdominal hernia or a history of abdominal mesh placement.
  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 is a litigant in a civil or criminal case or 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752827


Contacts
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Contact: Deborah Quigley 508-446-0266 info@prcclinical.com
Contact: Glenn Winnier, PhD 713 440 9900 gwinnier@ingeneron.com

Locations
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United States, Florida
Sports and Orthopedic Center Recruiting
Coral Springs, Florida, United States, 33067
Contact: Danahe Navarrete       dnavarrete@pioneerclinical.com   
Sponsors and Collaborators
InGeneron, Inc.
Investigators
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Principal Investigator: Jason Hurd, MD Sanford Orthopedics & Sports Medicine

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Responsible Party: InGeneron, Inc.
ClinicalTrials.gov Identifier: NCT03752827     History of Changes
Other Study ID Numbers: RC-002
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by InGeneron, Inc.:
rotator cuff tear
adipose-derived regenerative cells
adipose-derived stem cells
partial rotator cuff tears
corticosteroid
Additional relevant MeSH terms:
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Tendinopathy
Rotator Cuff Injuries
Wounds and Injuries
Rupture
Shoulder Injuries
Tendon Injuries
Muscular Diseases
Musculoskeletal Diseases