A Phase 2, Double-blinded, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Allogeneic Dermal Fibroblasts (TPX-115) in Patients With Partial-thickness Rotator Cuff Tear
Tego Science, Inc.
Summary
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 clinical symptoms including but not limited to pain, muscle weakness, or limited active range of motion (ROM) of PTRCT persisting for more than 3 months despite conservation treatment. * Patients who report a usual pain level of \>= 4 on visual analogue scale (VAS) at screening. * Patients who had, in t…
Interventions
- BiologicalTPX-115
Single injection of Allogeneic dermal fibroblasts (TPX-115) via ultrasound-guided intratendinous injection
- OtherCryopreserving hyaluronic acid medium
Medium included in TPX-115 for cryopreservation
- DrugSaline
Saline
Locations (3)
- BioSolutions Clinical Research CenterLa Mesa, California
- Sports & Orthopedic Center - Advanced ResearchDeerfield Beach, Florida
- Rush University Medical CenterChicago, Illinois