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

NCT06414005 | Recruiting Phase 2

• 1 other identifier: TG-TPX-115-22-02
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in shoulder score of Constant score (CS)

  The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25)

  24 weeks

Secondary Outcomes (8)

• Change in shoulder score of Constant score (CS)

  4, 12, 52 weeks

• hange in pain score of Visual Analogue Scale (VAS)

  4, 12, 24, 52 weeks

• Change of American Shoulder and Elbow Surgeons (ASES) Shoulder Score

  4, 12, 24, 52 weeks

• Change of Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Outcome Measure

  4, 12, 24, 52 weeks

• Change in Simple Shoulder Test (SST) Score

  4, 12, 24, 52 weeks

Study Arms (2)

TPX-115

EXPERIMENTAL

Subjects receive ultrasound-guided intratendinous injection of TPX-115

Biological: TPX-115

Placebo (Saline)

PLACEBO COMPARATOR

Subjects receive ultrasound-guided intratendinous placebo injection

Other: Placebo (Saline)

Interventions

TPX-115 BIOLOGICAL

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

TPX-115

Placebo (Saline) OTHER

Ultrasound-guided intratendinous placebo injection

Placebo (Saline)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tego Science, Inc.: lead

Study Sites (2)

Seoul National University Bundang Hospital

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

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Joo Han Oh, M.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jikhyon Han, Ph.D.

CONTACT

+82-2-818-2900; jhhan@tegoscience.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 14, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 5, 2024

Record last verified: 2024-03

Locations

KR (2)