Perianal FistulaPhase 1/2NCT05626023
A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
A Phase 1/2 study testing Human TH-SC01 cell injection in people with Perianal Fistula and Crohn's Disease, run by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perianal Fistula, Crohn's Disease
- What is being tested?
- Human TH-SC01 cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2022to 28 Feb 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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.
- Subjects with perianal fistula confirmed by clinical assessment and MRI.
- Subjects aged between 18 and 70, both male and female.
- 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.
- 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.
Who cannot join
- 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).
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- 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 gentamicin sulfate, anesthetics or contrast media.
- Subjects allergic to MRI contrast.
- Subjects who has received stem cells in a previous clinical study or as a therapeutic agent.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Safety and Tolerability of Human TH-SC01 Cell Injection for the Treatment of Perianal Fistulas in Crohn's Disease
The purpose of this study is to evaluate the safety and tolerability of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease
Read the detailed description
This study is a phase 1, single-arm, safety and tolerability study of human TH-SC01 cell injection for perianal fistulas in Crohn's Disease.
- Conditions
- Perianal Fistula, Crohn's Disease
- Being tested
- Human TH-SC01 cell injection
- 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 injectionDrug
Single injection of human TH-SC01 cell injection
| Study group | Role | What they receive |
|---|---|---|
| Human TH-SC01 cell injection | Experimental | Single injection of 0.6×10^7, 1.2×10^8, 1.8×10^8 cells/kg Receives: Drug: Human TH-SC01 cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and incidence of adverse events
Severity and incidence of adverse events within 28 days after adiministration
Measured: 28 days
Dose-limiting toxicity (DLT)
Exploration of dose-limiting toxicity (DLT)
Measured: 84 days
Maximum tolerated dose (MTD)
Exploration of maximum tolerated dose (MTD)
Measured: 84 days
Secondary outcomes (7)
Perianal fistula healing
Change from baseline in Van Assche Score by MRI test. The score range was from 0 to 25. Higher score means more severe disease.
Measured: 84 days
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: 84 days
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: 84 days
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: 84 days
VAS score
Change from baseline in pain score (VAS score).Total score ranges from 0 to 10. Higher score means more pain.
Measured: 84 days
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: 84 days
Anal sphincter function： rectal pressure
Change from baseline in rectal pressure，In healthy people, the pressure ranges from 60 to 150mmHg, with the internal sphincter pressure accounts for about 80% and external sphincter pressure accounts for 20%.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start30 Jan 2022
- Primary completion30 Aug 2023
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Changhai Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626023
- Sponsor's protocol ID
- TH-SC 2.0
- Status last verified
- Mar 2025
- First submitted
- 26 Oct 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Tolerability of Human TH-SC01 Cell Injection for the Treatment of Perianal Fistulas in Crohn's Disease
- ClinicalTrials.gov ID
- NCT05626023
- Acronym / sponsor ID
- TH-SC 2.0
- Conditions
- Perianal Fistula, Crohn's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Changhai Hospital
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease
Detailed description
This study is a phase 1, single-arm, safety and tolerability study of human TH-SC01 cell injection for perianal fistulas in Crohn's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human TH-SC01 cell injection | Experimental | Drug: Human TH-SC01 cell injectionSingle injection of 0.6×10^7, 1.2×10^8, 1.8×10^8 cells/kg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Subjects with perianal fistula confirmed by clinical assessment and MRI.
- Subjects aged between 18 and 70, both male and female.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human TH-SC01 cell injectionSingle injection of human TH-SC01 cell injection | Drug | Human TH-SC01 cell injection |
Primary outcome
Severity and incidence of adverse events
Time frame: 28 days
Severity and incidence of adverse events within 28 days after adiministration
Dose-limiting toxicity (DLT)
Time frame: 84 days
Exploration of dose-limiting toxicity (DLT)
Maximum tolerated dose (MTD)
Time frame: 84 days
Exploration of maximum tolerated dose (MTD)
7 secondary outcomes
Perianal fistula healing
Time frame: 84 days
Crohn's Disease Activity Index (CDAI) score
Time frame: 84 days
Perianal Disease Activity Index (PDAI)
Time frame: 84 days
Inflammatory Bowel Disease Questionnaire（IBDQ）score
Time frame: 84 days
VAS score
Time frame: 84 days
Anal sphincter function：Wexner incontinence score
Time frame: 84 days
Anal sphincter function： rectal pressure
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human TH-SC01 cell injection in people with Perianal Fistula and 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 16 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: finished, as of the sponsor's last update on 1 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity and incidence of adverse events (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.