A Phase I/III Clinical Study of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear

A Multi-center, Randomized, Independent Evaluator-Subject Blinded, Placebo-Controlled, Phase I/III Clinical Study to Evaluate Safety and Efficacy of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear

Rotator cuff tear is one of the most common shoulder diseases and retears occur frequently after arthroscopic repair. Therefore, there is a growing need of new therapy to improve structural outcome. This study evaluates the efficacy and safety of autologous fibroblasts during arthroscopic repair. The primary outcome is the retear rate at 24 weeks after administration of autologous fibroblasts (TPX-114) during arthroscopic repair. Secondary outcomes are functional evaluations including Range of Motion (ROM), Constant Score (CS), American Shoulder and Elbow Surgeons (ASES) score and Simple Shoulder Test (SST) at 24 and 52 weeks after administration.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injuries
• Intervention / Treatment: Biological: TPX-114; Procedure: Arthroscopic surgery

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants must;

1. Be 19 years of age or older.
2. Require arthroscopic repair for full-thickness rotator cuff tear(>2cm, ≤5cm) assessed by MRI without improvement of symptoms despite more than 3 months of conservative management.
3. Consent to undergo skin biopsy to manufacture test product.
4. Understand fully the study and voluntarily sign the informed consent for participation in the study.

Exclusion Criteria:

Participants with any of the following conditions will be excluded unless stated otherwise;

1. Unsuitable for skin biopsy.
2. Have additional subscapularis tear.

3. Have prior medical history of the following at the time of screening.

   • Operation of the affected shoulder
   • Allergies to bovine proteins
   • Anaphylaxis to gentamicin
   • Coagulopathy
   • Genetic disorders affecting fibroblasts or collagen (ex. achondroplasia, osteogenesis imperfecta)
   • Malignant tumors within the last 5 years

4. Have been diagnosed with any of the following diseases at the time of screening.

   • Autoimmune disease (including RA)
   • HIV Ab-positive
   • Acute trauma, chronic shoulder dislocation, pyogenic infection on the affected shoulder
   • Scapulohumeral osteoarthritis
5. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptives suggested in this study.
6. Other surgical or nonsurgical procedures on the affected shoulder to be judged more appropriate than arthroscopic repair.
7. Have participated in and received investigational agents in other clinical trials within 4 weeks of this study.
8. Be deemed inadequate for the study by investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPX-114; Subjects undergo arthroscopic rotator cuff repair with TPX-114.	Biological: TPX-114; Subjects will be treated with autologous fibroblasts (TPX-114) during arthroscopic surgery.; Procedure: Arthroscopic surgery; Subjects undergo conventional arthroscopic surgery for rotator cuff repair.
Placebo Comparator: Placebo; Subjects undergo arthroscopic surgery for rotator cuff repair without TPX-114.	Procedure: Arthroscopic surgery; Subjects undergo conventional arthroscopic surgery for rotator cuff repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retear Rate	Retear rate assessed by an independent evaluator with MRI	24 weeks

Collaborators and Investigators

• Sponsor: Tego Science, Inc.
• Investigators: Principal Investigator: Joo Han Oh, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): September 27, 2021
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: TPX-114-18-01; KCT0003174 (Registry Identifier: CRIS (Clinical Research Information Service, Rep. of Korea))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No