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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668028
Recruitment Status : Active, not recruiting
First Posted : September 12, 2018
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Tego Science, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Injuries Biological: TPX-114 Procedure: Arthroscopic surgery Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Retear Rate [ Time Frame: 24 weeks ]
    Retear rate assessed by an independent evaluator with MRI


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668028


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Tego Science, Inc.
Investigators
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Principal Investigator: Joo Han Oh Seoul National University Bundang Hospital
More Information
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Responsible Party: Tego Science, Inc.
ClinicalTrials.gov Identifier: NCT03668028    
Other Study ID Numbers: TPX-114-18-01
KCT0003174 ( Registry Identifier: CRIS (Clinical Research Information Service, Rep. of Korea) )
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries