NCT06414005 A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear
| NCT ID | NCT06414005 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Tego Science, Inc. |
| Condition | Partial Thickness Rotator Cuff Tear |
| Study Type | INTERVENTIONAL |
| Enrollment | 166 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 166 participants in total. It began in 2024-04-15 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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.
Contact & Investigator
Joo Han Oh, M.D.
PRINCIPAL INVESTIGATOR
Seoul National University Bundang Hospital
Frequently Asked Questions
Who can join the NCT06414005 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Partial Thickness Rotator Cuff Tear. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06414005 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06414005 currently recruiting?
Yes, NCT06414005 is actively recruiting participants. Contact the research team at jhhan@tegoscience.com for enrollment information.
Where is the NCT06414005 trial being conducted?
This trial is being conducted at Seongnam-si, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06414005 clinical trial?
NCT06414005 is sponsored by Tego Science, Inc.. The principal investigator is Joo Han Oh, M.D. at Seoul National University Bundang Hospital. The trial plans to enroll 166 participants.