Treatment for partial-thickness rotator cuff tears using TPX-115
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
This study is testing a new treatment called TPX-115 to see if it can help people with partial-thickness rotator cuff tears feel less pain and improve their shoulder function.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Tego Science, Inc. Industry-sponsored |
| Locations | 2 sites (Seongnam-si, Gyeonggi-do and 1 other locations) |
| Trial ID | NCT06414005 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of TPX-115, an allogeneic fibroblast therapy, for patients with partial-thickness rotator cuff tears. Participants will receive either TPX-115 or a placebo injection and will be monitored for changes in shoulder function and pain over a period of up to 52 weeks. The primary outcome measure is the change in Constant Score at 24 weeks, while secondary outcomes include various pain and functional assessments. The study aims to provide a new therapeutic option for patients who have not responded to conservative treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with unilateral partial-thickness rotator cuff tears and persistent shoulder pain despite conservative treatment.
Not a fit: Patients with full-thickness rotator cuff tears or those who have recently received certain treatments or injections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve shoulder function and reduce pain for patients with partial-thickness rotator cuff tears.
How similar studies have performed: While there is ongoing interest in fibroblast therapies for tendon injuries, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be 19 years of age or older. 2. Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade II assessed by MRI. 3. Have unilateral shoulder pain, muscle weakness and limited active range of motion lasting more than 3 months despite conservative treatment 4. VAS pain score ≥4 at screening. 5. Understand fully the study and voluntarily sign the informed consent for participation in the study. Exclusion Criteria: 1. Regardless of partial-thickness rotator cuff tear, have full-thickness rotator cuff tear confirmed by MRI. 2. 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. 3. 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 4. Have allergies to bovine proteins or gentamicin. 5. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study. 6. Have participated in other clinical trials and received investigational agents within 4 weeks of this study. 7. Be deemed inadequate for the study by investigators.
Where this trial is running
Seongnam-si, Gyeonggi-do and 1 other locations
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Joo Han Oh, M.D. — Seoul National University Bundang Hospital
- Study coordinator: Jikhyon Han, Ph.D.
- Email: jhhan@tegoscience.com
- Phone: +82-2-818-2900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.