NCT03668028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2018

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2022

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

3.2 years

First QC Date

September 11, 2018

Last Update Submit

May 17, 2023

Conditions

Rotator Cuff Injuries

Outcome Measures

Primary Outcomes (1)

  • Retear Rate

    Retear rate assessed by an independent evaluator with MRI

    24 weeks

Study Arms (2)

TPX-114

EXPERIMENTAL

Subjects undergo arthroscopic rotator cuff repair with TPX-114.

Biological: TPX-114Procedure: Arthroscopic surgery

Placebo

PLACEBO COMPARATOR

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

Procedure: Arthroscopic surgery

Interventions

TPX-114BIOLOGICAL

Subjects will be treated with autologous fibroblasts (TPX-114) during arthroscopic surgery.

TPX-114
Arthroscopic surgeryPROCEDURE

Subjects undergo conventional arthroscopic surgery for rotator cuff repair.

PlaceboTPX-114

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Interventions

Arthroscopy

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOrthopedic Procedures

Study Officials

  • Joo Han Oh

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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

September 11, 2018

First Posted

September 12, 2018

Study Start

July 9, 2018

Primary Completion

September 27, 2021

Study Completion

April 28, 2022

Last Updated

May 18, 2023

Record last verified: 2023-05

Locations

KR(2)