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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668028
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Tego Science, Inc.

Brief Summary:
Rotator cuff tear is one of the most common shoulder diseases and retears occure frequently after arthroscopic repair. Therefore, there is growing need of new therapy for improving structural outcome. This study evaluates the efficacy and safety of autologous fibroblasts during arthroscopic repair. The primary outcome is the retear rate after 24 weeks of arthroscopic repair with autologous fibroblasts. The secondary outcomes are functional evaluations including ROM, Constant score, ASES score and SST at 24 and 52 week.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 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 : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 male or female, 19 years of age and older.
  2. require arthroscopic repair for full-thickness rotator cuff tear(>2cm, ≤5cm) confirmed by MRI after 3 months of conservative management
  3. allow skin biopsy.
  4. be able and willing to give informed consent for participation in the trial

Exclusion Criteria:

Participants must not

  1. be inappropriate for skin biopsy.
  2. have subscapularis tear.
  3. have medical history of prior shoulder surgery, allergies to proteins of bovine origin, anaphylaxis to gentamicin, coagulopathy, genetic disorder related to fibroblasts or collagen (ex. achondroplasia, osteogenesis imperfecta) and malignant tumor within 5 years.
  4. have autoimmune disease including RA, positive HIV Ab result, acute trauma, chronic shoulder dislocation, pyogenic infection or scapulohumeral osteoarthritis at screening visit.
  5. be pregnant, state of breast feeding or disagree with the use of contraceptive method.
  6. require other surgical or nonsurgical procedures other than arthroscopic repair.
  7. have participated in other clinical trials and received investigational agents within 4 weeks before participation of this study.
  8. be considered inappropriate for this study by investigator.

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


Contacts
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Contact: Jikhyon Han 82)2-818-2900 jhhan@tegoscience.com
Contact: Mighye Kang 82)2-818-2900 mhkang17@tegoscience.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Joo Han Oh, Professor         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Sae Hoon Kim, Professor         
Sponsors and Collaborators
Tego Science, Inc.
Investigators
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Principal Investigator: Joo Han Oh Seoul National University Bundang Hospital
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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 1, 2020
Last Verified: June 2020
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