None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Experimental: Ultrasound-guided intratendinous injection of TPX-115
Control: Ultrasound-guided intratendinous placebo injection
Sponsors
Tego Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of ASES | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of ASES;Change of VAS pain score;Change of functional outcomes;Changes of tear size and thickness on MRI assessed by an independent evaluator;Changes of tear/footprint on MRI assessed by an independent evaluator;Changes of tendinosis grade on MRI assessed by an independent evaluator | — |
Countries
Korea, Republic of
Contacts
Public ContactMyeonggon Jeong
Seoul National University Bundang Hospital
Outcome results
None listed