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

Primary Purpose

Rotator Cuff Injuries

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

TPX-115

Placebo

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Seoul National University Bundang Hospital
Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TPX-115

Placebo

Arm Description

Subjects receive ultrasound-guided intratendinous injection of TPX-115

Subjects receive ultrasound-guided intratendinous placebo injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

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.

Change in Constant score (CS)

The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25)

Change in Simple Shoulder Test (SST) Score

SST assesses functional disability of the shoulder (function related to pain, function/strength and Range of Motion).

Change in tear size on Magnetic Resonance Image (MRI)

Tear size is assessed by an independent evaluator.

Change in tendon thickness on Magnetic Resonance Image (MRI)

Tendon thickness is assessed by an independent evaluator.

Change in tear/footprint on MRI

Ratio of tear lengths to whole footprint length is measured by an independent evaluator.

Change of tendinosis on MRI

Tendinosis is assessed with tendinosis grading system by an independent evaluator. (0: normal, 1: mild, 2: moderate, 3: marked)

Full Information

NCT ID

NCT04470167

First Posted

July 3, 2020

Last Updated

May 17, 2023

Sponsor

Tego Science, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04470167

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

October 26, 2020 (Actual)

Primary Completion Date

February 17, 2022 (Actual)

Study Completion Date

February 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tego Science, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TPX-115

Arm Type

Experimental

Arm Description

Subjects receive ultrasound-guided intratendinous injection of TPX-115

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects receive ultrasound-guided intratendinous placebo injection

Intervention Type

Biological

Intervention Name(s)

TPX-115

Intervention Description

Ultrasound-guided intratendinous injection of allogeneic fibroblasts(TPX-115)

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Ultrasound-guided intratendinous placebo injection

Primary Outcome Measure Information:

Title

Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)

Description

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)

Description

Time Frame

4, 12 weeks

Title

Change in pain score of Visual Analogue Scale (VAS)

Description

VAS pain score is measured on a scale of 0 (no pain) to 10 (worst pain imaginable).

Time Frame

4, 12, 24 weeks

Title

Change in Range of Motion (ROM)

Description

Measurement of ROM for forward elevation, external rotation at 90º abduction, external rotation at side and internal rotation at back.

Time Frame

4, 12, 24 weeks

Title

Change in Constant score (CS)

Description

The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25)

Time Frame

4, 12, 24 weeks

Title

Change in Simple Shoulder Test (SST) Score

Description

SST assesses functional disability of the shoulder (function related to pain, function/strength and Range of Motion).

Time Frame

4, 12, 24 weeks

Title

Change in tear size on Magnetic Resonance Image (MRI)

Description

Tear size is assessed by an independent evaluator.

Time Frame

24 weeks

Title

Change in tendon thickness on Magnetic Resonance Image (MRI)

Description

Tendon thickness is assessed by an independent evaluator.

Time Frame

24 weeks

Title

Change in tear/footprint on MRI

Description

Ratio of tear lengths to whole footprint length is measured by an independent evaluator.

Time Frame

24 weeks

Title

Change of tendinosis on MRI

Description

Tendinosis is assessed with tendinosis grading system by an independent evaluator. (0: normal, 1: mild, 2: moderate, 3: marked)

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joo Han Oh, Ph.D

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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