A Study of TH-SC01 for Treating Complex Perianal Fistula in Perianal Crohn's Disease.

NCT04939337 | Unknown Phase 1 DMC

• 1 other identifier: 20181231
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to asses the efficacy and Safety of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Complex Perianal Fistula in Perianal Crohn's Disease.

Conditions

Crohn's Disease

Keywords

Complex Perianal Fistulas

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who Achieve Combined Remission

  Combined remission is defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of abscess(es) \>2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by central magnetic resonance imaging (MRI) assessment or transrectal ultrasonography(TRUS)

  24 weeks

Secondary Outcomes (6)

• Percentage of Participants who Achieve Clinical Remission

  Up to Week 24

• Percentage of Participants who Achieve Clinical Response

  Up to Week 24

• Percentage of Participants who decrease in PDAI

  0、4、8、16、24 weeks

• Percentage of Participants who decrease in IBDQ

  0、4、8、16、24 weeks

• Percentage of Participants who decrease in VAS scale

  0、4、8、16、24 weeks

Study Arms (1)

TH-SC01

EXPERIMENTAL

TH-SC01 24 mL suspension of 120 million cells as a perilesional injection, once on Day 0.

Drug: TH-SC01

Interventions

TH-SC01 DRUG

Allogeneic Umbilical Cord-derived Mesenchymal Stem cells perilesional injection. Human TH-SC01 cell injection (human umbilical cord mesenchymal stem cells for injection, 5 million cells / ml, 6.0-10.0ml / bottle)

TH-SC01

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；
• \. According to the Diagnostic Criterion for Crohn's Disease in China's 《Consensus on the Diagnosis and Treatment of Inflammatory Bowel Disease》 (2018, Beijing), Crohn's disease was diagnosed at least 6 months before the screening period；
• \. Crohn's disease activity index (CDAI) score of 220 or less is defined as inactive or mildly active luminal Crohn's disease；
• \. Through clinical evaluation, MRI evaluation for anal fistula patients；
• \. Age 18 \~ 70, male or female；
• \. The serum or urine pregnancy test of a woman of reproductive age must be negative. Both men and women must agree to use a contraceptive method；
• \. According to the history and related examination, the general health condition is good；
• \. The eligible patients must at least meet one of the following conditions: patients who have failed to respond to any conventional treatment, such as conventional antibiotic therapy, immunomodulatory drug therapy, anti-tumor necrosis factor (TNF) α monoclonal antibody therapy, and 5-aminosalicylic acid

You may not qualify if:

• \. CDAI \> 220, or due to Crohn's disease activity, treatment needs to be upgraded immediately；
• \. Patients with abdominal and pelvic abscess or fistula diameter more than 2 cm；
• \. Patients with rectal and/or anal stenosis and/or active proctitis (due to limited surgical procedures)；
• \. The number of internal and / or external openings of anal fistula was more than 2 and 3 respectively;
• \. Patients who received steroid therapy within the first 4 weeks were screened；
• \. Abnormal laboratory test results： Liver function: total bilirubin ≥1.5 times the upper limit of normal value, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)≥2.5 times the upper limit of normal value; Renal function: Creatinine clearance below 60mL/min or 1.5 times the upper normal limit of serum creatinine (measured value or calculated by the Cockcroft-Gault formula)；
• Patients with malignancy or a history of malignancy, including fistula cancer of any type；
• \. Patients with severe, progressive, uncontrollable diseases of the liver, blood, gastrointestinal (except Crohn's disease), endocrine, lung, heart, neurological, psychiatric, or brain；
• \. HIV, syphilis antibody positive, HCV / HBV positive, tuberculosis in the infectious period, etc;
• \. Patients who are allergic to human serum albumin, human platelet lysates, anesthetic agents or contrast agents；
• \. Patients with contraindications to MRI scanning；
• \. Pregnant or lactating women and subjects who cannot commit to using effective contraceptives during the trial and for 6 months after the end of the trial；
• \. Patients who have undergone major surgery or severe trauma in the past six months；
• \. Patients who had received any study drug within a certain period of time prior to screening；
• Patients deemed ineligible to participate in this clinical trial by the investigator

Sponsors & Collaborators

• Jinling Hospital, China: lead
• Jiangsu Topcel-KH Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Jinling hospital

Nanjing, Jiangsu, 210002, China

Location

Related Publications (2)

• Thoreson R, Cullen JJ. Pathophysiology of inflammatory bowel disease: an overview. Surg Clin North Am. 2007 Jun;87(3):575-85. doi: 10.1016/j.suc.2007.03.001.

  PMID: 17560413 RESULT

• Wei J, Zhang Y, Chen C, Feng X, Yang Z, Feng J, Jiang Q, Fu J, Xuan J, Gao H, Liao L, Wang F. Efficacy and safety of allogeneic umbilical cord-derived mesenchymal stem cells for the treatment of complex perianal fistula in Crohn's disease: a pilot study. Stem Cell Res Ther. 2023 Oct 31;14(1):311. doi: 10.1186/s13287-023-03531-0.

  PMID: 37904247 DERIVED

Related Links

• Thoreson R, Cullen JJ. Pathophysiology of inflammatory bowel disease: an overview. Surg Clin North Am. 2007 Jun;87(3):575-85. Review.

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Wei Juan, doctor

  Jinling Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of digestive department

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 25, 2021
• Study Start: November 12, 2020
• Primary Completion: January 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)