## Protocol Section
### Identification Module
**NCT ID:** NCT06414005

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

**Official Title:** A Multi-center, Randomized, Double Blinded, Placebo-controlled, Phase 2b/3 Clinical Trial to Evaluate the Safety and Efficacy of TPX-115 in Patients With Partial-thickness Rotator Cuff Tear

#### Organization Study ID Info
**ID:** TG-TPX-115-22-02
#### Organization
**Class:** INDUSTRY
**Full Name:** Tego Science, Inc.
### Status Module
#### Completion Date
**Date:** 2027-01-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-15

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Tego Science, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Partial Thickness Rotator Cuff Tear

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 166

**Type:** ESTIMATED

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects receive ultrasound-guided intratendinous injection of TPX-115

**Intervention Names:**

- Biological: TPX-115

**Label:** TPX-115

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects receive ultrasound-guided intratendinous placebo injection

**Intervention Names:**

- Other: Placebo (Saline)

**Label:** Placebo (Saline)

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TPX-115

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

**Name:** TPX-115

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Placebo (Saline)

**Description:** Ultrasound-guided intratendinous placebo injection

**Name:** Placebo (Saline)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Change in shoulder score of Constant score (CS)

**Time Frame:** 24 weeks

#### Secondary Outcomes

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

**Measure:** Change in shoulder score of Constant score (CS)

**Time Frame:** 4, 12, 52 weeks

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

**Measure:** hange in pain score of Visual Analogue Scale (VAS)

**Time Frame:** 4, 12, 24, 52 weeks

**Description:** 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.

**Measure:** Change of American Shoulder and Elbow Surgeons (ASES) Shoulder Score

**Time Frame:** 4, 12, 24, 52 weeks

**Description:** 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.

**Measure:** Change of Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Outcome Measure

**Time Frame:** 4, 12, 24, 52 weeks

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

**Measure:** Change in Simple Shoulder Test (SST) Score

**Time Frame:** 4, 12, 24, 52 weeks

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

**Measure:** Change in Range of Motion (ROM)

**Time Frame:** 4, 12, 24, 52 weeks

**Description:** Ellman grade is assessed by an independent evaluator.

**Measure:** Change in Ellman grade on Magnetic Resonance Image (MRI)

**Time Frame:** 24, 52 weeks

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

**Measure:** Change of tendinosis on MRI

**Time Frame:** 24, 52 weeks

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jhhan@tegoscience.com

**Name:** Jikhyon Han, Ph.D.

**Phone:** +82-2-818-2900

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seongnam-si

**Contacts:**

***Contact 1:***

- **Name:** Joo Han Oh, Professor

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Seoul National University Bundang Hospital

**State:** Gyeonggi-do

**Status:** RECRUITING

**Zip:** 13620

#### Overall Officials

**Official 1:**

**Affiliation:** Seoul National University Bundang Hospital

**Name:** Joo Han Oh, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012421

- Term: Rupture

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000070599

- Term: Shoulder Injuries

- ID: D000013708

- Term: Tendon Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15241

- Name: Rupture

- Relevance: LOW

- As Found: Unknown

- ID: M22785

- Name: Lacerations

- Relevance: LOW

- As Found: Unknown

- ID: M624

- Name: Rotator Cuff Injuries

- Relevance: HIGH

- As Found: Rotator Cuff Tears

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M602

- Name: Shoulder Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M16479

- Name: Tendon Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000070636

- Term: Rotator Cuff Injuries

### Misc Info Module

- Version Holder: 2024-05-31
