## Protocol Section
### Identification Module
**NCT ID:** NCT06429241

**Brief Title:** Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula

**Official Title:** A Phase I Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Perianal Fistula

#### Organization Study ID Info
**ID:** 2023-TH-SC01-I-007
#### Organization
**Class:** INDUSTRY
**Full Name:** Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** The First Affiliated Hospital of Soochow University

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula

**Detailed Description:** A Phase I clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula

### Conditions Module

**Conditions:**

- Anal Fistula

- Complex Perianal Fistulas

- Crohn's Disease

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 8

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Intralesional injection of expanded human umbilical cord-derived mesenchymal stem cells suspension.

**Intervention Names:**

- Biological: Mesenchymal Stem Cells (MSCs)

**Label:** MSCs treatment group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MSCs treatment group

**Description:** single dose injection (120 million cells)

**Name:** Mesenchymal Stem Cells (MSCs)

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** Standardized values of organs or tissues after PET/CT imaging after local injection in patients with perianal fistula

**Measure:** Standardized uptake value

**Time Frame:** 8-12 hour、32-36 hour、56-60 hour、104-108 hour、152-156 hour，296-300 hour

#### Secondary Outcomes

**Description:** Change from baseline in pain score (VAS score).Total score ranges from 0 to 10. Higher score means more pain.

**Measure:** Effectiveness endpoint:Proportion of subjects with clinically significant effect at week 24 after local injection

**Time Frame:** Week 1，Week 4，Week 24

**Description:** All subjects were observed for any adverse events/reactions or serious adverse events/reactions that occurred during the clinical trial, including but not limited to clinically significant abnormal changes in clinical symptoms, physical examination, vital signs examination, laboratory examination, 12-lead electrocardiogram examination, etc. The clinical features, severity, occurrence time, end time, treatment and outcome of the disease should be recorded, and the correlation between the disease and the investigational drug should be determined.

**Measure:** Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events

**Time Frame:** Week 1，Week 4，Week 24，Month 24

**Description:** Based on the image data obtained by PET/CT scan, OLINDA's sphere model was used to delineate the injection site and important organs or tissues as areas of interest (ROI), obtain standardized uptake values (SUV) of each ROI, and obtain time-radioactive activity curves (TACs) of each tissue and organ. The absorbed dose of vital organs or tissues, the equivalent dose of the whole body, and the distribution and change of transplanted cells in different tissues or organs at different time points are described

**Measure:** Radiation exposure: Uptake rate (%ID), absorbed dose, and systemic effective dose in vital organs or tissues after local injection of nuclide labeled TH-SC01 cells.

**Time Frame:** Week 1

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Signed informed consent
2. Subjects with Crohn\&amp;#39;s disease or complex perianal fistula diagnosed at least 6 months earlier according to the Chinese Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Diseases (Beijing, 2018).Subjects with active perianal fistula and non active luminal CD defined by a CDAI ≤ 200.
3. For patients with perianal fistula, 1≤ the number of internal openings ≤2, and 1≤ the number of external openings ≤3, the fistula of the patient needs to be drained smoothly
4. All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.
5. ECOG score 0\~1, ASA grade I\~II
6. Subjects failed to respond to adequate treatment with any of the conventional antibiotics, immunomodulatory drugs (including steroids), anti-tumor necrosis factor-α (TNF-α) monoclonal antibodies and other biological agents.

Exclusion Criteria:

1. Subjects with active infection evaluated by the investigator.
2. Subjects with Crohn\&amp;amp;amp;#39;s disease requiring immediate therapy.
3. Subjects with abscess or collections \&amp;amp;amp;gt;2 cm.
4. Subjects with rectal and/or anal stenosis and/or active proctitis.
5. Subjects who treated with systemic steroids in the 4 weeks prior to stem cells administration.
6. Subjects with abnormal laboratory results: liver function: total bilirubin \&amp;amp;amp;gt;=1.5 × ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \&amp;amp;amp;gt;=2 × ULN; renal function: creatinine clearance below 60 mL/minute calculated using Cockcroft-Gault formula or by serum creatinine \&amp;amp;amp;gt;=1.5 × upper limit of normal (ULN).
7. Subjects with malignant tumors or a history of malignant tumors.
8. Subjects with severe, progressive, uncontrolled hepatic, hematological, gastrointestinal (except Crohn\&amp;amp;amp;#39;s disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases.
9. Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
10. Subjects allergic to Human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic drug
11. Subjects who has received stem cells therapy.
12. Subjects who has major surgery or severe trauma within 6 months prior to the screening period.
13. Subjects who has received any investigational drug within 3 months prior to the screening.
14. Subjects deemed inappropriate by the investigator to participate in this clinical trial.
15. The female participant who is pregnant, or is lactating.
16. Not suitable for PET/CT examination.
17. Participants considered inappropriate to participate in this clinical trial

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** E-mail:sdfyec@163.com

**Name:** Miu Li Yan The First Affiliated Hospital of Soochow University

**Phone:** 86+0512-67972858

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015212

- Term: Inflammatory Bowel Diseases

- ID: D000005759

- Term: Gastroenteritis

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000007412

- Term: Intestinal Fistula

- ID: D000016154

- Term: Digestive System Fistula

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6638

- Name: Crohn Disease

- Relevance: HIGH

- As Found: Crohn's Disease

- ID: M8532

- Name: Fistula

- Relevance: HIGH

- As Found: Fistula

- ID: M14845

- Name: Rectal Fistula

- Relevance: HIGH

- As Found: Perianal Fistula

- ID: M17917

- Name: Inflammatory Bowel Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M10446

- Name: Intestinal Fistula

- Relevance: LOW

- As Found: Unknown

- ID: M18616

- Name: Digestive System Fistula

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003424

- Term: Crohn Disease

- ID: D000012003

- Term: Rectal Fistula

- ID: D000005402

- Term: Fistula

### Misc Info Module

- Version Holder: 2024-05-31
