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Partial Thickness Rotator Cuff TearPhase 2/3NCT06414005

A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear

A Phase 2/3 study testing TPX-115 in people with Partial Thickness Rotator Cuff Tear, run by Tego Science, Inc. at 2 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
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
Partial Thickness Rotator Cuff Tear
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
166 participants
Where
2 sitesSouth Korea
Study dates
15 Apr 2024to 31 Jan 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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

  • Be 19 years of age or older.
  • Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade II assessed by MRI.
  • Have unilateral shoulder pain, muscle weakness and limited active range of motion lasting more than 3 months despite conservative treatment
  • VAS pain score ≥4 at screening.
  • Understand fully the study and voluntarily sign the informed consent for participation in the study.

Who cannot join

  • Regardless of partial-thickness rotator cuff tear, have full-thickness rotator cuff tear confirmed by MRI.
  • Have been treated with the following
  • Have had painkiller within 1 week prior to screening visit.
  • Have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit.
  • Have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit.
  • Have shoulder surgery on the rotator cuff tear or had received drug that included growth factor, within 6 months prior to screening visit.
Show all 20Show fewer
  • Have been diagnosed with the following diseases.
  • 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. Contact the study team or a site near you to ask about taking part.

Jikhyon Han, Ph.D. contact

+82-2-818-2900

jhhan@tegoscience.com

South Korea2 sites, 2 recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Joo Han Oh, Professor

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Sae Hoon Kim, Professor

    Recruiting

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Double Blinded, Placebo-controlled, Phase 2b/3 Clinical Trial to Evaluate the 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 Constant Score (CS) at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in CS, Visual Analogue Score (VAS) pain score, American Shoulder and Elbow Surgeons (ASES) score, Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH), Simple Shoulder Test (SST), and functional evaluations including Range of Motion (ROM) at 4, 12, 24 and 52 weeks after administration and structural evaluation using MRI at 24 and 52 weeks after injection.

Being tested
TPX-115, Placebo (Saline)

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)

  • Placebo (Saline)Other

    Ultrasound-guided intratendinous placebo injection

Study groups in NCT06414005
Study groupRoleWhat they receive
TPX-115ExperimentalSubjects receive ultrasound-guided intratendinous injection of TPX-115
Receives: Biological: TPX-115
Placebo (Saline)Placebo comparatorSubjects receive ultrasound-guided intratendinous placebo injection
Receives: Other: Placebo (Saline)

What is being measured

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

  1. Change in shoulder score of Constant score (CS)

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

    Measured: 24 weeks

Secondary outcomes (8)

  1. Change in shoulder score of Constant score (CS)

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

    Measured: 4, 12, 52 weeks

  2. hange 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, 52 weeks

  3. Change of American Shoulder and Elbow Surgeons (ASES) Shoulder Score

    ASES shoulder score is derived from the visual analogue scale score for pain and the activities of daily living score. The total score(100 maximum points) is weighted 50% for pain and 50% for function.

    Measured: 4, 12, 24, 52 weeks

  4. Change of Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Outcome Measure

    The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.

    Measured: 4, 12, 24, 52 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, 52 weeks

  6. 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, 52 weeks

  7. Change in Ellman grade on Magnetic Resonance Image (MRI)

    Ellman grade is assessed by an independent evaluator.

    Measured: 24, 52 weeks

  8. 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, 52 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 May 2024
  2. Study start15 Apr 2024
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
166 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06414005
Sponsor's protocol ID
TG-TPX-115-22-02
Status last verified
Mar 2024
First submitted
10 May 2024
Last updated
5 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TPX-115 in people with Partial Thickness Rotator Cuff Tear, 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 20 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: looking for participants now, as of the sponsor's last update on 5 Jun 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jikhyon Han, Ph.D. (+82-2-818-2900, jhhan@tegoscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in shoulder score of Constant score (CS) (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 NCT06414005.

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 5 Jun 2024.

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