Clinical trial NCT04470167: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rotator Cuff Injuries
Lead sponsor: Tego Science, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-14
Enrollment: 49
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)
timeFrame: 4, 12 weeks
measure: Change in pain score of Visual Analogue Scale (VAS)
timeFrame: 4, 12, 24 weeks
measure: Change in Range of Motion (ROM)
timeFrame: 4, 12, 24 weeks
measure: Change in Constant score (CS)
timeFrame: 4, 12, 24 weeks
measure: Change in Simple Shoulder Test (SST) Score
timeFrame: 4, 12, 24 weeks
measure: Change in tear size on Magnetic Resonance Image (MRI)
timeFrame: 24 weeks
measure: Change in tendon thickness on Magnetic Resonance Image (MRI)
timeFrame: 24 weeks
measure: Change in tear/footprint on MRI
timeFrame: 24 weeks
measure: Change of tendinosis on MRI
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Joo Han Oh, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: