Status:
RECRUITING
A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear
Lead Sponsor:
Tego Science, Inc.
Conditions:
Partial Thickness Rotator Cuff Tear
Eligibility:
All Genders
19+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 n...
Eligibility Criteria
Inclusion Criteria:
- Be 19 years of age or older.
- Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade II assessed by MRI.
- Have unilateral shoulder pain, muscle weakness and limited active range of motion lasting more than 3 months despite conservative treatment
- VAS pain score ≥4 at screening.
- Understand fully the study and voluntarily sign the informed consent for participation in the study.
Exclusion Criteria:
-
Regardless of partial-thickness rotator cuff tear, have full-thickness rotator cuff tear confirmed by MRI.
-
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.
-
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
-
Have allergies to bovine proteins or gentamicin.
-
Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study.
-
Have participated in other clinical trials and received investigational agents within 4 weeks of this study.
-
Be deemed inadequate for the study by investigators.
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT06414005
Start Date
April 15 2024
End Date
January 31 2027
Last Update
June 5 2024
Active Locations (2)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
2
Seoul National University Hospital
Seoul, South Korea, 03080