Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414005
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-10
Brief Title:
A Phase 2b3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear
Sponsor:
Tego Science Inc
Organization:
Tego Science Inc
Study Overview
Official Title:
A Multi-center Randomized Double Blinded Placebo-controlled Phase 2b3 Clinical Trial to Evaluate the Safety and Efficacy of TPX-115 in Patients With Partial-thickness Rotator Cuff Tear
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None