Phase 1/2 Clinical Study of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear

A Multi-center, Randomized, Independent Evaluator-blinded, Subject-blinded, Placebo-controlled, Phase 1/2 Clinical Study to Evaluate 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 American Shoulder and Elbow Surgeons (ASES) score at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in Visual Analogue Score (VAS) pain score, functional evaluations including Range of Motion (ROM), Constant Score (CS), ASES score and Simple Shoulder Test (SST) at 4, 12 and 24 weeks after administration and structural evaluation using MRI at 24 weeks after injection.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injuries
• Intervention / Treatment: Biological: TPX-115; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants must;

1. Be 19 years of age or older.
2. Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade I, II assessed by MRI.
3. Have unilateral shoulder pain lasting more than 3 months despite conservative treatment and VAS pain score ≥5 at screening.
4. Understand fully the study and voluntarily sign the informed consent for participation in the study.

Exclusion Criteria:

Participants with any of the following conditions will be excluded unless stated otherwise;

1. 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.
2. 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.).
3. Have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit.
4. Have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit.

5. 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
6. Have allergies to bovine proteins or gentamicin.
7. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study.
8. Have participated in other clinical trials and received investigational agents within 4 weeks of this study
9. Be deemed inadequate for the study by investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPX-115; Subjects receive ultrasound-guided intratendinous injection of TPX-115	Biological: TPX-115; Ultrasound-guided intratendinous injection of allogeneic fibroblasts(TPX-115)
Placebo Comparator: Placebo; Subjects receive ultrasound-guided intratendinous placebo injection	Other: Placebo; Ultrasound-guided intratendinous placebo injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)	ASES shoulder score is derived from the Visual Analogue Scale (VAS) score for pain and activities of daily living score. The total score - maximum of 100 points - is weighted 50% for pain and 50% for function.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)	ASES shoulder score is derived from the Visual Analogue Scale (VAS) score for pain and the activities of daily living score. The total score - maximum of points - is weighted 50% for pain and 50% for function.	4, 12 weeks
Change 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 weeks
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 weeks
Change in Constant score (CS)	The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25)	4, 12, 24 weeks
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 weeks
Change in tear size on Magnetic Resonance Image (MRI)	Tear size is assessed by an independent evaluator.	24 weeks
Change in tendon thickness on Magnetic Resonance Image (MRI)	Tendon thickness is assessed by an independent evaluator.	24 weeks
Change in tear/footprint on MRI	Ratio of tear lengths to whole footprint length is measured by an independent evaluator.	24 weeks
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 weeks

Collaborators and Investigators

• Sponsor: Tego Science, Inc.
• Investigators: Principal Investigator: Joo Han Oh, Ph.D, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): February 17, 2022

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: TG-TPX-115-20-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No