Complex Perianal FistulasPhase 1/2NCT05677672
The Purpose of This Study is to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Complex Perianal Fistula
A Phase 1/2 study testing Human TH-SC01 Cell Injection and Saline solution in people with Complex Perianal Fistulas, 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 efficacy of human TH-SC01 cell injection for the treatment of complex perianal fistulas Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Complex Perianal Fistulas
- 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
- 84 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2022to 30 Dec 2023
- 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 aged between 18 and 70, both male and female.
- The subject was clinically diagnosed as complex anal fistula. The diagnostic criteria for complex anal fistula were adopted by the 2016 American Association of Colorectal Surgeons Guidelines for the Treatment of Perianal Abscess, Anal Fistula and Rectovaginal Fistula.
- The subjects had received conventional treatment for anal fistulas
- 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 with anal fistula in the acute infection period.
- Subjects with abscess or collections >2 cm.
- 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.
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- Subjects allergic to gentamicin sulfate, anesthetics or contrast media.
- Subjects allergic to MRI contrast.
- 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.
China1 site
Xiangya Hospital Central University
Changsha, Hunan, 410000
Weidong Zhang, Dr., 073189753568, davidcsu@foxmail.com
About this study
Official title: Phase I/Ⅱ Study to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Complex Perianal Fistula
The purpose of this study is to evaluate the safety and efficacy of human TH-SC01 cell injection for the treatment of complex perianal fistulas
Read the detailed description
This study is a phase Ⅰ/Ⅱ study, Phase 1 was the dose increment phase, and phase 2 was the expansion phase
- Conditions
- Complex Perianal Fistulas
- Being tested
- Human TH-SC01 Cell Injection, Saline solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human TH-SC01 Cell InjectionBiological
Single injection of 0.6×10^7,1.2×10^8, 1.8×10^8 cells/kg
Saline solutionOther
saline solution will be given at the same quantity and following the same schedule
| Study group | Role | What they receive |
|---|---|---|
| Human TH-SC01 cell injection | Experimental | Human TH-SC01 Cell Injection is a human expanded umbilical cord mesenchymal stem cells suspension Receives: Biological: Human TH-SC01 Cell Injection |
| Placebo-control group | Placebo comparator | Saline solution Receives: Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and incidence of study drug-related adverse-events
Severity and incidence of study drug-related adverse-events within D28(W4) after administration.
Measured: Day 28 (Week 4)
Dose-limiting toxicity (DLT)
Exploration of dose-limiting toxicity (DLT)
Measured: Day 28
maximum tolerated dose (MTD)
Exploration of maximum tolerated dose(MTD)
Measured: Day 28
Percentage of effectiveness
Percentage of effectiveness at 84 days of administration by MRI imaging evaluated fistula healing with no or minimal effusion
Measured: Day 84
Secondary outcomes (1)
Severity and incidence of study drug-related adverse-events
Severity and incidence of study drug-related adverse-events after D28(W4) after administration.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start30 Dec 2022 (estimated)
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Perianal FistulasStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1 was a non-randomized, single-arm, multicenter, dose-escalation clinical trial design. Phase 2 was a randomized, double-masking , multicenter, blank control, dose-extended clinical trial design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xiangya Hospital of Central South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677672
- Sponsor's protocol ID
- TH-SC01-CAF-Ⅰ/Ⅱ 1.0
- Status last verified
- Dec 2022
- First submitted
- 14 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/Ⅱ Study to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Complex Perianal Fistula
- ClinicalTrials.gov ID
- NCT05677672
- Acronym / sponsor ID
- TH-SC01-CAF-Ⅰ/Ⅱ 1.0
- Conditions
- Complex Perianal Fistulas
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Xiangya Hospital of Central South University
- Study start
- 30 Dec 2022 (estimated)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 10 Jan 2023 (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 efficacy of human TH-SC01 cell injection for the treatment of complex perianal fistulas
Detailed description
This study is a phase Ⅰ/Ⅱ study, Phase 1 was the dose increment phase, and phase 2 was the expansion phase
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 1 was a non-randomized, single-arm, multicenter, dose-escalation clinical trial design. Phase 2 was a randomized, double-masking , multicenter, blank control, dose-extended clinical trial design.
| Arm | Type | Receives |
|---|---|---|
| Human TH-SC01 cell injection | Experimental | Biological: Human TH-SC01 Cell InjectionHuman TH-SC01 Cell Injection is a human expanded umbilical cord mesenchymal stem cells suspension |
| Placebo-control group | Placebo comparator | Other: Saline solutionSaline solution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent.
- Subjects aged between 18 and 70, both male and female.
- The subject was clinically diagnosed as complex anal fistula. The diagnostic criteria for complex anal fistula were adopted by the 2016 American Association of Colorectal Surgeons Guidelines for the Treatment of Perianal Abscess, Anal Fistula and Rectovaginal Fistula.
- The subjects had received conventional treatment for anal fistulas
- 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.
Key exclusion criteria (12 listed)
- Subjects with anal fistula in the acute infection period.
- Subjects with abscess or collections >2 cm.
- 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.
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 0.6×10^7,1.2×10^8, 1.8×10^8 cells/kg | Biological | Human TH-SC01 cell injection |
| Saline solutionsaline solution will be given at the same quantity and following the same schedule | Other | Placebo-control group |
Primary outcome
Severity and incidence of study drug-related adverse-events
Time frame: Day 28 (Week 4)
Severity and incidence of study drug-related adverse-events within D28(W4) after administration.
Dose-limiting toxicity (DLT)
Time frame: Day 28
Exploration of dose-limiting toxicity (DLT)
maximum tolerated dose (MTD)
Time frame: Day 28
Exploration of maximum tolerated dose(MTD)
Percentage of effectiveness
Time frame: Day 84
Percentage of effectiveness at 84 days of administration by MRI imaging evaluated fistula healing with no or minimal effusion
1 secondary outcome
Severity and incidence of study drug-related adverse-events
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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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.
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 and Saline solution in people with Complex Perianal Fistulas, 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 10 Jan 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity and incidence of study drug-related adverse-events (time frame: Day 28 (Week 4)). The study lists 4 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 10 Jan 2023.