The goal of this study is to evaluate the efficacy and safety of allogeneic dermal fibroblasts (TPX-115) compared to placebo in patients with Partial-Thickness Rotator Cuff Tear(PTRCT). Primary endpoint is to evaluate the efficacy of TPX-115 compared to placebo, as measured by improvement in the Constant-Murley Score (CMS) in patients with PTRCT. Secondary endpoints are: * To evaluate functional (including shoulder pain) and structural improvements in the affected shoulder after administration of TPX-115 compared to placebo in patients with PTRCT * To evaluate the safety and tolerability of TPX-115 in patients with PTRCT * To assess the immunogenicity of TPX-115
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Single injection of Allogeneic dermal fibroblasts (TPX-115) via ultrasound-guided intratendinous injection
Medium included in TPX-115 for cryopreservation
Saline
BioSolutions Clinical Research Center
La Mesa, California, United States
Sports & Orthopedic Center - Advanced Research
Deerfield Beach, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Change from baseline in Constant-Murley Score(CMS) at Week 24
The CMS is calculated from 0 (worst function) to 100 (best function) points
Time frame: Baseline, Week 24
Change from baseline in Constant-Murley Score(CMS) at Weeks 4, 12, and 52
The CMS is calculated from 0 (worst function) to 100 (best function) points
Time frame: Baseline, Week 4, Week 12, Week 52
Increase of at least 8 points from baseline in Constant-Murley Score(CMS) at Week 24
The CMS is calculated from 0 (worst function) to 100 (best function) points
Time frame: Baseline, Week 24
Change from baseline in Visual Analogue Scale(VAS) (0 to 10 cm) score for shoulder pain at Weeks 4, 12, 24, and 52
The VAS is a horizontal line, 10 cm in length, with anchor statements on the left (0 cm; meaning 'no pain') and on the right (10cm; meaning 'extreme pain')
Time frame: Baseline, Week 4, Week 12, Week 24, Week 52
Change from baseline in Range of Motion(ROM) in the affected shoulder at Weeks 4, 12, 24, and 52
Time frame: Baseline, Week 4, Week 12, Week 24, Week 52
Change from baseline in American Shoulder and Elbow Surgeons(ASES) score at Weeks 4, 12, 24, and 52
The ASES score is calculated from zero (worst) to 100 (best) points
Time frame: Baseline, Week 4, Week 12, Week 24, Week 52
Change from baseline in Simple Shoulder Test at Weeks 4, 12, 24, and 52
Time frame: Baseline, Week 4, Week 12, Week 24, Week 52
Change from baseline in tear size (mm) on MRI at Week 52
Time frame: Baseline, Week 52
Change from baseline in tendon thickness (mm) on MRI at Week 52
Time frame: Baseline, Week 52
Change from baseline in tear/footprint (%p) on MRI at Week 52
Time frame: Baseline, Week 52
Change from baseline in tendinosis on MRI at Week 52
The grade of tendinosis is assessed from zero (normal) to 3 (marked) by a central reader only (independent evaluator).
Time frame: Baseline, Week 52
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