A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear
Recruiting
Phase 2
Phase 3
Interventional Study
Partial Thickness Rotator Cuff Tear
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 166 (estimated)
- Sponsor
- Tego Science, Inc. · Industry
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About This Trial
Rotator cuff tear is one of the most common shoulder diseases and conservative treatment is commonly used for tears involving ≤50% of tendon thickness. Since conventional conservative treatments are not fundamental to repair tendon tissue, there is a growing need of new therapy to improve structural outcome. This study assesses the safety and efficacy of allogeneic fibroblasts on partial-thickness…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Be 19 years of age or older.
2. Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade II assessed by MRI.
3. Have unilateral shoulder pain, muscle weakness and limited active range of motion lasting more than 3 months despite conservative treat…
Contacts