Status:
COMPLETED
Phase 1/2 Clinical Study of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear
Lead Sponsor:
Tego Science, Inc.
Conditions:
Rotator Cuff Injuries
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
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
- Participants must;
- Be 19 years of age or older.
- Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade I, II assessed by MRI.
- Have unilateral shoulder pain lasting more than 3 months despite conservative treatment and VAS pain score ≥5 at screening.
- Understand fully the study and voluntarily sign the informed consent for participation in the study.
Exclusion
- Participants with any of the following conditions will be excluded unless stated otherwise;
- Have partial-thickness rotator cuff tear larger than 50% of tendon thickness or of Ellman grade III, or full-thickness rotator cuff tear confirmed by MRI.
- Have prior medical history of shoulder surgery on the torn rotator cuff or the upper part of shoulder within 6 months prior to screening visit (shoulder trauma, fracture, upper cervical spine surgery, etc.).
- Have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit.
- Have had received systemic steroid or immunosuppressive agents within 4 weeks 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 :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2022
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04470167
Start Date
October 26 2020
End Date
February 17 2022
Last Update
May 18 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
2
Seoul National University Hospital
Seoul, South Korea, 03080