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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
168
Adipose-derived regenerative cells isolated with the Transpose Ultra system
Corticosteroid injection into subacrominal space
Arizona Research Center
Phoenix, Arizona, United States
Biosolutions Clinical Research Center
La Mesa, California, United States
Lotus Clinical Research, LLC
Improvement in Pain: VAS
≥ 14-millimeter (mm) improvement in Visual Analog Scale (VAS)
Time frame: 24 weeks
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
Time frame: 24 weeks
Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS
Pain score compared to baseline at 24 weeks
Time frame: 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
Time frame: 24 weeks
Mean improvement in VAS - Pain score
VAS pain score compared to baseline
Time frame: 12 and 24 weeks
Mean improvement in WORC score
WORC score compared to baseline
Time frame: 12 and 24 weeks
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.
Time frame: 24 weeks
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