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

NCT06429241 | Recruiting Phase 1

• 1 other identifier: 2023-TH-SC01-I-007
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Anal Fistula; Complex Perianal Fistulas; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Standardized uptake value

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

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

Secondary Outcomes (3)

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

  Week 1，Week 4，Week 24

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

  Week 1，Week 4，Week 24，Month 24

• 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.

  Week 1

Study Arms (1)

MSCs treatment group

EXPERIMENTAL

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

Biological: Mesenchymal Stem Cells (MSCs)

Interventions

Mesenchymal Stem Cells (MSCs) BIOLOGICAL

single dose injection (120 million cells)

MSCs treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Subjects with Crohn\'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.
• 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
• 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.
• ECOG score 0\~1, ASA grade I\~II
• 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.

You may not qualify if:

• Subjects with active infection evaluated by the investigator.
• Subjects with Crohn\'s disease requiring immediate therapy.
• Subjects with abscess or collections \>2 cm.
• Subjects with rectal and/or anal stenosis and/or active proctitis.
• Subjects who treated with systemic steroids in the 4 weeks prior to stem cells administration.
• Subjects with abnormal laboratory results: liver function: total bilirubin \>=1.5 × ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \>=2 × ULN; renal function: creatinine clearance below 60 mL/minute calculated using Cockcroft-Gault formula or by serum creatinine \>=1.5 × upper limit of normal (ULN).
• Subjects with malignant tumors or a history of malignant tumors.
• Subjects with severe, progressive, uncontrolled hepatic, hematological, gastrointestinal (except Crohn\'s disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases.
• Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
• Subjects allergic to Human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic drug
• Subjects who has received stem cells therapy.
• Subjects who has major surgery or severe trauma within 6 months prior to the screening period.
• Subjects who has received any investigational drug within 3 months prior to the screening.
• Subjects deemed inappropriate by the investigator to participate in this clinical trial.
• The female participant who is pregnant, or is lactating.

Sponsors & Collaborators

• Jiangsu Topcel-KH Pharmaceutical Co., Ltd.: lead
• The First Affiliated Hospital of Soochow University: collaborator

Study Sites (1)

The first Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Rectal Fistula; Crohn Disease

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammatory Bowel Diseases; Gastroenteritis

Central Study Contacts

Miu Li Yan The First Affiliated Hospital of Soochow University

CONTACT

86+0512-67972858; E-mail:sdfyec@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 24, 2024
• Study Start: April 8, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2025
• Last Updated: June 12, 2024

Record last verified: 2024-05

Locations

CN (1)