Phase 1/2 Clinical Study of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear

NCT04470167 | Completed Phase 1

• 1 other identifier: TG-TPX-115-20-01
• Study Type: interventional
• Target: 49
• 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 American Shoulder and Elbow Surgeons (ASES) score at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in Visual Analogue Score (VAS) pain score, functional evaluations including Range of Motion (ROM), Constant Score (CS), ASES score and Simple Shoulder Test (SST) at 4, 12 and 24 weeks after administration and structural evaluation using MRI at 24 weeks after injection.

Conditions

Rotator Cuff Injuries

Outcome Measures

Primary Outcomes (1)

• Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)

  ASES shoulder score is derived from the Visual Analogue Scale (VAS) score for pain and activities of daily living score. The total score - maximum of 100 points - is weighted 50% for pain and 50% for function.

  24 weeks

Secondary Outcomes (9)

• Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)

  4, 12 weeks

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

  4, 12, 24 weeks

• Change in Range of Motion (ROM)

  4, 12, 24 weeks

• Change in Constant score (CS)

  4, 12, 24 weeks

• Change in Simple Shoulder Test (SST) Score

  4, 12, 24 weeks

Study Arms (2)

TPX-115

EXPERIMENTAL

Subjects receive ultrasound-guided intratendinous injection of TPX-115

Biological: TPX-115

Placebo

PLACEBO COMPARATOR

Subjects receive ultrasound-guided intratendinous placebo injection

Other: Placebo

Interventions

TPX-115 BIOLOGICAL

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

TPX-115

Placebo OTHER

Ultrasound-guided intratendinous placebo injection

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tego Science, Inc.: lead

Study Sites (2)

Seoul National University Bundang Hospital

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

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Joo Han Oh, Ph.D

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: July 3, 2020
• First Posted: July 14, 2020
• Study Start: October 26, 2020
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)