Partial Thickness Rotator Cuff Tear Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 166 |
| Est. completion date | January 31, 2027 |
| Est. primary completion date | June 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
| Korea, Republic of | Seoul National University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Tego Science, Inc. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in shoulder score of Constant score (CS) | The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25) | 24 weeks | |
| Secondary | Change in shoulder score of Constant score (CS) | The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25). | 4, 12, 52 weeks | |
| Secondary | 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). | 4, 12, 24, 52 weeks | |
| Secondary | 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. | 4, 12, 24, 52 weeks | |
| Secondary | 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. | 4, 12, 24, 52 weeks | |
| Secondary | Change in Simple Shoulder Test (SST) Score | SST assesses functional disability of the shoulder (function related to pain, function/strength and Range of Motion). | 4, 12, 24, 52 weeks | |
| Secondary | 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. | 4, 12, 24, 52 weeks | |
| Secondary | Change in Ellman grade on Magnetic Resonance Image (MRI) | Ellman grade is assessed by an independent evaluator. | 24, 52 weeks | |
| Secondary | Change of tendinosis on MRI | Tendinosis is assessed with tendinosis grading system by an independent evaluator. (0: normal, 1: mild, 2: moderate, 3: marked) | 24, 52 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01123889 -
Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection
|
N/A | |
| Terminated |
NCT03597490 -
Multimodal Physical Therapy With Exercise in Partial-thickness Rotator Cuff Tears
|
||
| Enrolling by invitation |
NCT05400798 -
A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
|
N/A |