Efficacy and Safety Study of TPX-115 on Partial-thickness Rotator Cuff Tear

Recruiting Phase 2 Interventional Study
Partial Thickness Rotator Cuff Tears
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Tego Science, Inc. · Industry
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About This Trial
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 functiona…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients aged \>= 18 years. * Patients with PTRCT involving \<= 50% of the tendon thickness based on depth of defect (or Grade I or II on Ellman classification) assessed by MRI within the last 3 months prior to screening and determined by the investigator. * Patients with clin…
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