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

NCT ID: NCT06414005

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2027-01-31

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 not fundamental to repair tendon tissue, there is a growing need of new therapy to improve structural outcome. This study assesses the safety and efficacy of allogeneic fibroblasts on partial-thickness rotator cuff tear. The primary outcome is change in Constant Score (CS) at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in CS, Visual Analogue Score (VAS) pain score, American Shoulder and Elbow Surgeons (ASES) score, Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH), Simple Shoulder Test (SST), and functional evaluations including Range of Motion (ROM) at 4, 12, 24 and 52 weeks after administration and structural evaluation using MRI at 24 and 52 weeks after injection.

Conditions

Partial Thickness Rotator Cuff Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TPX-115

Subjects receive ultrasound-guided intratendinous injection of TPX-115

Group Type: EXPERIMENTAL

TPX-115

Intervention Type: BIOLOGICAL

Ultrasound-guided intratendinous injection of allogeneic fibroblasts (TPX-115)

Placebo (Saline)

Subjects receive ultrasound-guided intratendinous placebo injection

Group Type: PLACEBO_COMPARATOR

Placebo (Saline)

Intervention Type: OTHER

Ultrasound-guided intratendinous placebo injection

Interventions

TPX-115

Ultrasound-guided intratendinous injection of allogeneic fibroblasts (TPX-115)

Intervention Type: BIOLOGICAL

Placebo (Saline)

Ultrasound-guided intratendinous placebo injection

Intervention Type: OTHER

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tego Science, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joo Han Oh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jikhyon Han, Ph.D.

Role: CONTACT

jhhan@tegoscience.com

+82-2-818-2900

Facility Contacts

Joo Han Oh, Professor

Role: primary

Sae Hoon Kim, Professor

Role: primary

Other Identifiers

TG-TPX-115-22-02

Identifier Type: -

Identifier Source: org_study_id