Rotator Cuff InjuriesPhase 3NCT03668028
A Phase I/III Clinical Study of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear
A Phase 3 study testing TPX-114 and Arthroscopic surgery in people with Rotator Cuff Injuries, run by Tego Science, Inc. at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- TPX-114 and Arthroscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 9 Jul 2018to 28 Apr 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
About this study
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
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.
- Conditions
- Rotator Cuff Injuries
- Being tested
- TPX-114, Arthroscopic surgery
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPX-114Biological
Subjects will be treated with autologous fibroblasts (TPX-114) during arthroscopic surgery.
Arthroscopic surgeryProcedure or surgery
Subjects undergo conventional arthroscopic surgery for rotator cuff repair.
| Study group | Role | What they receive |
|---|---|---|
| TPX-114 | Experimental | Subjects undergo arthroscopic rotator cuff repair with TPX-114. Receives: Biological: TPX-114; Procedure: Arthroscopic surgery |
| Placebo | Placebo comparator | Subjects undergo arthroscopic surgery for rotator cuff repair without TPX-114. Receives: Procedure: Arthroscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retear Rate
Retear rate assessed by an independent evaluator with MRI
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start9 Jul 2018
- Primary completion27 Sep 2021
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tego Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joo Han Oh, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668028
- Sponsor's protocol ID
- TPX-114-18-01
- Other IDs
- KCT0003174
- Status last verified
- May 2023
- First submitted
- 11 Sep 2018
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03668028
- Acronym / sponsor ID
- TPX-114-18-01
- Conditions
- Rotator Cuff Injuries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Tego Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPX-114 | Experimental | Biological: TPX-114, Procedure: Arthroscopic surgerySubjects undergo arthroscopic rotator cuff repair with TPX-114. |
| Placebo | Placebo comparator | Procedure: Arthroscopic surgerySubjects undergo arthroscopic surgery for rotator cuff repair without TPX-114. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
- Have been diagnosed with any of the following diseases at the time of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPX-114Subjects will be treated with autologous fibroblasts (TPX-114) during arthroscopic surgery. | Biological | TPX-114 |
| Arthroscopic surgerySubjects undergo conventional arthroscopic surgery for rotator cuff repair. | Procedure or surgery | Placebo, TPX-114 |
Primary outcome
Retear Rate
Time frame: 24 weeks
Retear rate assessed by an independent evaluator with MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo Han Oh principal investigator
Seoul National University Bundang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TPX-114 and Arthroscopic surgery in people with Rotator Cuff Injuries, run by Tego Science, Inc. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retear Rate (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.