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

Rotator Cuff Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04470167
• Other study ID #: TG-TPX-115-20-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 26, 2020
• Est. completion date: February 17, 2022

Study information

• Verified date: May 2023
• Source: Tego Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 17, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries

Intervention

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

Other:
• Placebo
Ultrasound-guided intratendinous placebo injection

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Tego Science, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in tear size on Magnetic Resonance Image (MRI)	Tear size is assessed by an independent evaluator.	24 weeks
Secondary	Change in tendon thickness on Magnetic Resonance Image (MRI)	Tendon thickness is assessed by an independent evaluator.	24 weeks
Secondary	Change in tear/footprint on MRI	Ratio of tear lengths to whole footprint length is measured by an independent evaluator.	24 weeks
Secondary	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