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

Primary Purpose

Rotator Cuff Injuries

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TPX-114
Arthroscopic surgery
Sponsored by
Tego Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Bundang Hospital
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TPX-114

Placebo

Arm Description

Subjects undergo arthroscopic rotator cuff repair with TPX-114.

Subjects undergo arthroscopic surgery for rotator cuff repair without TPX-114.

Outcomes

Primary Outcome Measures

Retear Rate
Retear rate assessed by an independent evaluator with MRI

Secondary Outcome Measures

Full Information

First Posted
September 11, 2018
Last Updated
May 17, 2023
Sponsor
Tego Science, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03668028
Brief Title
A Phase I/III Clinical Study of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
April 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tego Science, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TPX-114
Arm Type
Experimental
Arm Description
Subjects undergo arthroscopic rotator cuff repair with TPX-114.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects undergo arthroscopic surgery for rotator cuff repair without TPX-114.
Intervention Type
Biological
Intervention Name(s)
TPX-114
Intervention Description
Subjects will be treated with autologous fibroblasts (TPX-114) during arthroscopic surgery.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic surgery
Intervention Description
Subjects undergo conventional arthroscopic surgery for rotator cuff repair.
Primary Outcome Measure Information:
Title
Retear Rate
Description
Retear rate assessed by an independent evaluator with MRI
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must; Be 19 years of age or older. 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. Consent to undergo skin biopsy to manufacture test product. 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; Unsuitable for skin biopsy. Have additional subscapularis tear. 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 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 Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptives suggested in this study. Other surgical or nonsurgical procedures on the affected shoulder to be judged more appropriate than arthroscopic repair. Have participated in and received investigational agents in other clinical trials within 4 weeks of this study. Be deemed inadequate for the study by investigators.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo Han Oh
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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