A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear

Phase 2

Recruiting

• Conditions: Partial Thickness Rotator Cuff Tear
• Interventions: Biological: TPX-115; Other: Placebo (Saline)

• Registration Number: NCT06414005
• Lead Sponsor: Tego Science, Inc.

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

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-04-15
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-14
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Primary Completion: 2026-06-30
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 166

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPX-115	TPX-115	Subjects receive ultrasound-guided intratendinous injection of TPX-115
Placebo (Saline)	Placebo (Saline)	Subjects receive ultrasound-guided intratendinous placebo injection

Primary Outcome Measures

Name	Time	Method
Change in shoulder score of Constant score (CS)	24 weeks	The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25)

Secondary Outcome Measures

Name	Time	Method
hange in pain score of Visual Analogue Scale (VAS)	4, 12, 24, 52 weeks	VAS pain score is measured on a scale of 0 (no pain) to 10 (worst pain imaginable).
Change in Ellman grade on Magnetic Resonance Image (MRI)	24, 52 weeks	Ellman grade is assessed by an independent evaluator.
Change of tendinosis on MRI	24, 52 weeks	Tendinosis is assessed with tendinosis grading system by an independent evaluator. (0: normal, 1: mild, 2: moderate, 3: marked)
Change in shoulder score of Constant score (CS)	4, 12, 52 weeks	The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25).
Change of American Shoulder and Elbow Surgeons (ASES) Shoulder Score	4, 12, 24, 52 weeks	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.
Change of Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Outcome Measure	4, 12, 24, 52 weeks	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.
Change in Simple Shoulder Test (SST) Score	4, 12, 24, 52 weeks	SST assesses functional disability of the shoulder (function related to pain, function/strength and Range of Motion).
Change in Range of Motion (ROM)	4, 12, 24, 52 weeks	Measurement of ROM for forward elevation, external rotation at 90º abduction, external rotation at side and internal rotation at back.

Trial Locations

Locations (2)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of