A Prospective, Double-Blinded, Multi-Center Pivotal Trial of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
Overview
- Phase
- Not Applicable
- Intervention
- Adipose Derived Regenerative Cells
- Conditions
- Rotator Cuff Tear
- Sponsor
- InGeneron, Inc.
- Enrollment
- 168
- Locations
- 14
- Primary Endpoint
- Improvement or no worsening in supraspinatus strength
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
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 \>
- •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).
Arms & Interventions
Adipose Derived Regenerative Cells
Adipose-derived regenerative cell injection into the area of the supraspinatus tendon tear
Intervention: Adipose Derived Regenerative Cells
Corticosteroid
Subjects in the active control arm will receive a corticosteroid injection into the subacromial space using ultrasound (US) guidance.
Intervention: Corticosteroid
Outcomes
Primary Outcomes
Improvement or no worsening in supraspinatus strength
Time Frame: 24 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
Improvement in Pain: VAS
Time Frame: 24 weeks
≥ 14-millimeter (mm) improvement in Visual Analog Scale (VAS)
Secondary Outcomes
- Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS(24 weeks)
- Mean improvement in VAS - Pain score(12 and 24 weeks)
- Mean improvement in WORC score(12 and 24 weeks)
- Percentage of subjects who demonstrate a ≥ 1-grade improvement in supraspinatus strength on the MRC Muscle Scale(24 weeks)
- Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale(24 weeks)