AzTrials
AzTrials

Crohn's DiseasePhase 3NCT06925594

Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease

A Phase 3 study testing Human TH-SC01 cell injection and Saline solution in people with Crohn's Disease, run by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease over 24 weeks. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Crohn's Disease
What is being tested?
Human TH-SC01 cell injection and Saline solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
228 participants
Where
1 siteChina
Study dates
20 Mar 2025to 28 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Subjects with Crohn's disease 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.
  • Presence of perianal fistulas with a maximum of 2 fistulas (internal openings) and a maximum of 3 external openings, assessed by clinical assessment and MRI.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
  • American Society of Anesthesiologists (ASA) physical status classification of grade I to grade II.
  • 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.

Who cannot join

  • Subjects allergic to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic drugs or MRI contrast agents.
  • Subjects with active infection evaluated by the investigator
  • Subjects with active Crohn's disease before drug administration or have not completed the induction-phase treatment.
  • Subjects with abscess or collections >2 cm.
  • Rectal and/or anal stenosis , if this means a limitation for any surgical procedure
  • Subjects with concurrent active proctitis.
Show all 22Show fewer
  • Subjects with other fistulas such as rectum/anal canal-vaginal fistulas or rectum-bladder fistulas.
  • Patients have undergone a diverting stoma operation in the past, except for patients have completed stoma closure at least one month before drug administration.
  • Patients plan to undergo surgery in the perianal area during the trial period due to other diseases other than anal fistula.
  • 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).
  • Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
  • Subjects with malignant tumors or a history of malignant tumors.
  • Subjects with congenital or acquired immunodeficiency.
  • Contraindication to MRI scan
  • Current or recent history of abnormal, severe, progressive, uncontrolled hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease.
  • Subjects received stem cell treatment within two years prior to screening.
  • Patient with ongoing steroid treatment or treated with steroids in the last 4 weeks.
  • Patient undergone major surgical operations (such as orthopedic surgery, abdominal surgery) within one month before drug administration, or Patient plan to receive surgeries during the study period (except for the surgeries required by the procedures of this trial).
  • Patients with a history of drug abuse or alcoholism (Criteria for alcoholism: having a long-term drinking history of more than 5 years, with the amount of ethanol equivalent to ≥40g/d for men and ≥20g/d for women, or having a history of heavy drinking within 2 weeks, with the amount of ethanol equivalent to >80g/d. The conversion formula for the amount of ethanol (g) = the amount of alcohol consumed (ml) × the ethanol content (%) × 0.8).
  • Pregnant or lactating women.
  • Patients with a history of diverting ostomy, except those who have undergone stoma reversal at least 1 month prior to drug administration.
  • Other diseases or conditions that the investigator deems inappropriate for participating in this clinical trial, such as poor subject compliance and the expectation of being unable to complete follow-up and evaluation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jueyu Xia, Master contact

025-52700103

xiajueyu@topcelbio.com

China1 site, 1 recruiting

  • Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

    Nanjing, Jiangsu

    Jueyu Xia, Master, 025-52700103, xiajueyu@topcelbio.com

    Zhaoshen Li, Ph.D.

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Human TH-SC01 Cell Injection in the Treatment of Anal Fistulas in Patients With Non-active/Mildly Active Crohn's Disease

The purpose of this study is to evaluate the efficacy of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease over 24 weeks.

Conditions
Crohn's Disease
Being tested
Human TH-SC01 cell injection, Saline solution
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human TH-SC01 cell injectionOther

    Human TH-SC01 cell injection is a cell suspension in aseptic buffered solution containing human expanded umbilical cord-derived stem cells of allogeneic origin in disposable vials with no preservative agents. The cells will be given at a dose of 120 million cells (5 million cells / mL) for intralesional injection.

  • Saline solutionOther

    Placebo (saline solution) will be given also for intralesional injection at the same quantity (volume, 24 mL) and following the same schedule.

Study groups in NCT06925594
Study groupRoleWhat they receive
Treatment ArmExperimental120 million cells administered by intralesional injection.
Receives: Other: Human TH-SC01 cell injection
Placebo-control groupPlacebo comparator24 mL saline solution by intralesional injection
Receives: Other: Saline solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of subjects achieved combined remission

    Combined Remission of perianal fistulising Crohn's disease defined as the all treated external openings achieved clinical remission at week 24， and absence of collections > 2 cm of the treated perianal fistulas confirmed by centrally blinded MRI assessment by week 24.

    Measured: 24 weeks

Secondary outcomes (11)

  1. The proportion of subjects achieved clinical remission

    Clinical Remission defined as closure of all treated external openings that were draining at baseline despite gentle finger compression, and no obvious fistulas can be felt by digital examination，as clinically assessed.

    Measured: 24 weeks ，52 weeks and104 weeks

  2. The proportion of subjects achieved a clinical response

    Clinical response defined as closure of at least 50% of all treated external openings that were draining at baseline, as clinically assessed

    Measured: 24 weeks，52 weeks and104 weeks

  3. The proportion of subjects recurrence

    Recurrence defined as the reopening of the closed external openings that had achieved clinical remission after treatment, the appearance of spontaneous fluid drainage, or the presence of fistulas with fluid collections > 2 cm as assessed by enhanced pelvic MRI

    Measured: 24 weeks，52 weeks and104 weeks

  4. Time to achieve clinical remission, clinical response and recurrence

    Time to achieve clinical remission, clinical response and recurrence within 24 weeks after drug administration.

    Measured: 24 weeks，52 weeks and104 weeks

  5. The proportion of subjects achieved combined remission

    Combined Remission of perianal fistulising Crohn's disease at week 52 and 104 (as defined for week 24)

    Measured: 52 weeks and104 weeks

  6. VAS score

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

    Measured: 24 weeks，52 weeks and104 weeks

  7. Perianal Disease Activity Index (PDAI)

    Change from baseline in Perianal Disease Activity Index (PDAI). Total score ranges from 0 to 20. Higher score means more severe disease

    Measured: 24 weeks，52 weeks and104 weeks

  8. Crohn's Disease Activity Index (CDAI) score

    Change from baseline in the Crohn's Disease Activity Index (CDAI) score. Higher score means more severe disease and especially severe disease was defined as a value of greater than 450

    Measured: 24 weeks，52 weeks and104 weeks

  9. Inflammatory Bowel Disease Questionnaire（IBDQ）score

    Change from baseline in IBDQ score. Total score ranges from 32 to 224. Higher score means better quality of life

    Measured: 24 weeks，52 weeks and104 weeks

  10. Anal sphincter function：Wexner incontinence score

    Change from baseline in anal sphincter function, Wexner incontinence score,Total score ranges from 0 to 20. Higher score means more severe disease

    Measured: 24 weeks，52 weeks and104 weeks

  11. peripheral blood cytokines

    Changes in the levels of peripheral blood cytokines compared to the baseline.

    Measured: 2 weeks，4 weeks ，8 weeks ，12weeks and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2025
  2. Study start20 Mar 2025
  3. Primary completion28 Dec 2026 (estimated)
  4. Study completion28 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
228 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06925594
Sponsor's protocol ID
TH-SC01-CD-Ⅲ-01
Status last verified
Mar 2025
First submitted
7 Apr 2025
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Human TH-SC01 cell injection and Saline solution in people with Crohn's Disease, run by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jueyu Xia, Master (025-52700103, xiajueyu@topcelbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects achieved combined remission (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06925594.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in