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Recruiting NCT06414005

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

Phase II / Phase III Interventional Partial Thickness Rotator Cuff Tear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TPX-115, Placebo (Saline).
Who it may be relevant to
Registry conditions: Partial Thickness Rotator Cuff Tear. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multi-center, Randomized, Double Blinded, Placebo-controlled, Phase 2b/3 Clinical Trial to Evaluate the Safety and Efficacy of TPX-115 in Patients With Partial-thickness Rotator Cuff Tear

Overview

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.

Interventions

  • Biological TPX-115
    Ultrasound-guided intratendinous injection of allogeneic fibroblasts (TPX-115)
  • Other Placebo (Saline)
    Ultrasound-guided intratendinous placebo injection

Primary outcome measures

  • Change in shoulder score of Constant score (CS) [Time frame: 24 weeks]
Secondary outcome measures (8)
  • Change in shoulder score of Constant score (CS) [Time frame: 4, 12, 52 weeks]
  • hange in pain score of Visual Analogue Scale (VAS) [Time frame: 4, 12, 24, 52 weeks]
  • Change of American Shoulder and Elbow Surgeons (ASES) Shoulder Score [Time frame: 4, 12, 24, 52 weeks]
  • Change of Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Outcome Measure [Time frame: 4, 12, 24, 52 weeks]
  • Change in Simple Shoulder Test (SST) Score [Time frame: 4, 12, 24, 52 weeks]
  • Change in Range of Motion (ROM) [Time frame: 4, 12, 24, 52 weeks]
  • Change in Ellman grade on Magnetic Resonance Image (MRI) [Time frame: 24, 52 weeks]
  • Change of tendinosis on MRI [Time frame: 24, 52 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

South Korea · 2 centers
  • Seoul National University Bundang Hospital — Seongnam-si
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT06414005 · TG-TPX-115-22-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗