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.
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…
Contacts
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