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Rotator Cuff InjuriesPhase 1/2NCT04470167

Phase 1/2 Clinical Study of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear

A Phase 1/2 study testing TPX-115 in people with Rotator Cuff Injuries, run by Tego Science, Inc. at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rotator cuff tear is one of the most common shoulder diseases and conservative treatment is commonly used for tears involving ≤50% of tendon thickness. Since conventional conservative treatments are not fundamental to repair tendon tissue, there is a growing need of new therapy to improve structural outcome. 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-115
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
2 sitesSouth Korea
Study dates
26 Oct 2020to 17 Feb 2022
Phase
Phase 1/2
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.
  • Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade I, II assessed by MRI.
  • Have unilateral shoulder pain lasting more than 3 months despite conservative treatment and VAS pain score ≥5 at screening.
  • 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;
  • Have partial-thickness rotator cuff tear larger than 50% of tendon thickness or of Ellman grade III, or full-thickness rotator cuff tear confirmed by MRI.
  • Have prior medical history of shoulder surgery on the torn rotator cuff or the upper part of shoulder within 6 months prior to screening visit (shoulder trauma, fracture, upper cervical spine surgery, etc.).
  • Have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit.
  • Have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit.
  • Have been diagnosed with the following diseases.
Show all 19Show fewer
  • Inflammatory joint diseases
  • Other shoulder diseases which may cause shoulder pain or functional disorder
  • Autoimmune diseases
  • Active hepatitis B or C
  • HIV Ab positive
  • Malignant tumors within the last 5 years
  • Coagulopathy
  • Genetic disorders related to fibroblasts of collagen
  • Other serious diseases deemed to affect the results of the study
  • Have allergies to bovine proteins or gentamicin.
  • Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study.
  • Have participated in other clinical trials and received investigational agents 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

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Independent Evaluator-blinded, Subject-blinded, Placebo-controlled, Phase 1/2 Clinical Study to Evaluate Safety and Efficacy of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear

Rotator cuff tear is one of the most common shoulder diseases and conservative treatment is commonly used for tears involving ≤50% of tendon thickness. Since conventional conservative treatments are not fundamental to repair tendon tissue, there is a growing need of new therapy to improve structural outcome. This study assesses the safety and efficacy of allogeneic fibroblasts on partial-thickness rotator cuff tear. The primary outcome is change in American Shoulder and Elbow Surgeons (ASES) score at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in Visual Analogue Score (VAS) pain score, functional evaluations including Range of Motion (ROM), Constant Score (CS), ASES score and Simple Shoulder Test (SST) at 4, 12 and 24 weeks after administration and structural evaluation using MRI at 24 weeks after injection.

Being tested
TPX-115, Placebo
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-115Biological

    Ultrasound-guided intratendinous injection of allogeneic fibroblasts(TPX-115)

  • PlaceboOther

    Ultrasound-guided intratendinous placebo injection

Study groups in NCT04470167
Study groupRoleWhat they receive
TPX-115ExperimentalSubjects receive ultrasound-guided intratendinous injection of TPX-115
Receives: Biological: TPX-115
PlaceboPlacebo comparatorSubjects receive ultrasound-guided intratendinous placebo injection
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)

    ASES shoulder score is derived from the Visual Analogue Scale (VAS) score for pain and activities of daily living score. The total score - maximum of 100 points - is weighted 50% for pain and 50% for function.

    Measured: 24 weeks

Secondary outcomes (9)

  1. Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)

    ASES shoulder score is derived from the Visual Analogue Scale (VAS) score for pain and the activities of daily living score. The total score - maximum of points - is weighted 50% for pain and 50% for function.

    Measured: 4, 12 weeks

  2. Change in pain score of Visual Analogue Scale (VAS)

    VAS pain score is measured on a scale of 0 (no pain) to 10 (worst pain imaginable).

    Measured: 4, 12, 24 weeks

  3. Change in Range of Motion (ROM)

    Measurement of ROM for forward elevation, external rotation at 90º abduction, external rotation at side and internal rotation at back.

    Measured: 4, 12, 24 weeks

  4. Change in Constant score (CS)

    The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25)

    Measured: 4, 12, 24 weeks

  5. Change in Simple Shoulder Test (SST) Score

    SST assesses functional disability of the shoulder (function related to pain, function/strength and Range of Motion).

    Measured: 4, 12, 24 weeks

  6. Change in tear size on Magnetic Resonance Image (MRI)

    Tear size is assessed by an independent evaluator.

    Measured: 24 weeks

  7. Change in tendon thickness on Magnetic Resonance Image (MRI)

    Tendon thickness is assessed by an independent evaluator.

    Measured: 24 weeks

  8. Change in tear/footprint on MRI

    Ratio of tear lengths to whole footprint length is measured by an independent evaluator.

    Measured: 24 weeks

  9. Change of tendinosis on MRI

    Tendinosis is assessed with tendinosis grading system by an independent evaluator. (0: normal, 1: mild, 2: moderate, 3: marked)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2020
  2. Study start26 Oct 2020
  3. Primary completion17 Feb 2022
  4. Study completion17 Feb 2022

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04470167
Sponsor's protocol ID
TG-TPX-115-20-01
Status last verified
May 2023
First submitted
3 Jul 2020
Last updated
18 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TPX-115 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change in shoulder score of American Shoulder and Elbow Surgeons (ASES) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04470167.

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.

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