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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
Led by Tego Science, Inc. · Updated on 2024-06-05
166
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Partial-thickness rotator cuff tear is a common shoulder condition where tears involve 50% or less of the tendon thickness. This trial evaluates the safety and effectiveness of an investigational treatment called TPX-115, which consists of allogeneic fibroblasts injected into the tendon. The study aims to improve tendon repair beyond standard conservative treatments by measuring shoulder function and pain scores over time. Participants are randomly assigned to receive either TPX-115 or a placebo injection guided by ultrasound directly into the tendon. The study is double-blinded, meaning neither participants nor researchers know which treatment is given. Assessments occur at 4, 12, 24, and 52 weeks after injection, with structural evaluations using MRI at 24 and 52 weeks to monitor tendon changes. During the study, participants will complete various shoulder function tests including the Constant Score, pain assessments using Visual Analogue Scale, and other shoulder-specific questionnaires. Range of motion and MRI scans will also be performed to observe physical and structural changes. The primary outcome is the change in Constant Score at 24 weeks, with ongoing safety and efficacy monitoring through one year of follow-up.
CONDITIONS
Brief Title
A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 19 years of age or older
- Have a partial-thickness rotator cuff tear involving 50% or less of tendon thickness or Ellman grade II confirmed by MRI
- Experience unilateral shoulder pain, muscle weakness, and limited active range of motion lasting more than 3 months despite conservative treatment
- Have a Visual Analogue Scale (VAS) pain score of 4 or higher at screening
- Understand the study and voluntarily sign informed consent
You will not qualify if you...
- Have a full-thickness rotator cuff tear confirmed by MRI
- Have used painkillers within 1 week prior to screening
- Have received systemic steroid or immunosuppressive agents within 4 weeks prior to screening
- Have had subacromial or intra-articular injections to the affected shoulder within 3 months prior to screening
- Have had shoulder surgery on the rotator cuff or received drugs with growth factors within 6 months prior to screening
- Diagnosed with inflammatory joint diseases, other shoulder diseases causing pain or dysfunction, autoimmune diseases, active hepatitis B or C, HIV positive, malignant tumors within 5 years, coagulopathy, genetic fibroblast or collagen disorders, or other serious diseases affecting study results
- Allergic to bovine proteins or gentamicin
- Pregnant, breastfeeding, planning pregnancy, or unwilling to use contraception as suggested
- Participated in other clinical trials with investigational agents within 4 weeks
- Deemed inadequate for the study by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single injection with follow-up up to 52 weeks
Participants receive an ultrasound-guided intratendinous injection of either TPX-115 or placebo to treat partial-thickness rotator cuff tear.
Visits at 4, 12, 24, and 52 weeks post-injection
Trial Site Locations
Total: 2 locations
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
2
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
Research Team
J
Jikhyon Han, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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