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:

  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.

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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Page 1 of 1 (2 locations)

1

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 13620

2

Seoul National University Hospital

Seoul, South Korea, 03080