A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear

Launched by TEGO SCIENCE, INC. · May 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TPX-115 for people with partial-thickness rotator cuff tears in their shoulders. A rotator cuff tear is a common shoulder issue that can cause pain and difficulty moving the arm. This study aims to see if injecting allogeneic fibroblasts (cells that help repair tissue) can improve healing and reduce pain. Participants will be monitored for changes in their shoulder function and pain levels over 24 weeks, with follow-ups at 4, 12, and 52 weeks.

To be eligible for this trial, participants must be at least 19 years old and have shoulder pain and weakness due to a partial-thickness rotator cuff tear that has lasted more than three months, despite other treatments. They should also have a certain level of pain at the start of the study. However, those with more severe tears or certain medical conditions will not be able to participate. Throughout the trial, participants can expect regular evaluations to track their progress and may also undergo MRI scans to see how well the treatment is working. This study is currently recruiting participants, and anyone interested should talk to their doctor to see if they qualify.

Gender

ALL

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 treatment
• • 4. VAS pain score ≥4 at screening.
• • 5. Understand fully the study and voluntarily sign the informed consent for participation in the study.
• Exclusion Criteria:
• • 1. Regardless of partial-thickness rotator cuff tear, have full-thickness rotator cuff tear confirmed by MRI.
• • 2. Have been treated with the following
• • Have had painkiller within 1 week prior to screening visit.
• • Have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit.
• • Have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit.
• • Have shoulder surgery on the rotator cuff tear or had received drug that included growth factor, within 6 months prior to screening visit.
• • 3. Have been diagnosed with the following diseases.
• • Inflammatory joint diseases
• • Other shoulder diseases which may cause shoulder pain or functional disorder
• • Autoimmune diseases
• • Active hepatitis B or C
• • HIV Ab positive
• • Malignant tumors within the last 5 years
• • Coagulopathy
• • Genetic disorders related to fibroblasts of collagen
• • Other serious diseases deemed to affect the results of the study
• • 4. Have allergies to bovine proteins or gentamicin.
• • 5. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study.
• • 6. Have participated in other clinical trials and received investigational agents within 4 weeks of this study.
• • 7. Be deemed inadequate for the study by investigators.