Anal FistulaPhase 1NCT06429241
Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula
A Phase 1 study testing Mesenchymal Stem Cells (MSCs) in people with Anal Fistula and 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 distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anal Fistula, Complex Perianal Fistulas, Crohn's Disease
- What is being tested?
- Mesenchymal Stem Cells (MSCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2024to Dec 2025
- Phase
- Phase 1
- 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 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.
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 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.
- Not suitable for PET/CT examination.
- Participants considered inappropriate to participate in this clinical trial
Trial locations and contacts
1 site in 1 country.
Miu Li Yan The First Affiliated Hospital of Soochow University contact
China1 site, 1 recruiting
- Recruiting
The first Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Yan Wang, MD, 0512-67972858, sdfyy8040@126.com
About this study
Official title: A Phase I Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Perianal Fistula
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
Read the detailed description
A Phase I clinical study evaluating 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
- Being tested
- Mesenchymal Stem Cells (MSCs)
- Medical subject headings
- Rectal Fistula, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cells (MSCs)Biological
single dose injection (120 million cells)
| Study group | Role | What they receive |
|---|---|---|
| MSCs treatment group | Experimental | Intralesional injection of expanded human umbilical cord-derived mesenchymal stem cells suspension. Receives: Biological: Mesenchymal Stem Cells (MSCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value
Standardized values of organs or tissues after PET/CT imaging after local injection in patients with perianal fistula
Measured: 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
Change from baseline in pain score (VAS score).Total score ranges from 0 to 10. Higher score means more pain.
Measured: Week 1，Week 4，Week 24
Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events
All subjects were observed for any adverse events/reactions or serious adverse events/reactions that occurred during the clinical trial, including but not limited to clinically significant abnormal changes in clinical symptoms, physical examination, vital signs examination, laboratory examination, 12-lead electrocardiogram examination, etc. The clinical features, severity, occurrence time, end time, treatment and outcome of the disease should be recorded, and the correlation between the disease and the investigational drug should be determined.
Measured: 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.
Based on the image data obtained by PET/CT scan, OLINDA's sphere model was used to delineate the injection site and important organs or tissues as areas of interest (ROI), obtain standardized uptake values (SUV) of each ROI, and obtain time-radioactive activity curves (TACs) of each tissue and organ. The absorbed dose of vital organs or tissues, the equivalent dose of the whole body, and the distribution and change of transplanted cells in different tissues or organs at different time points are described
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start8 Apr 2024
- Primary completionNov 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429241
- Sponsor's protocol ID
- 2023-TH-SC01-I-007
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Perianal Fistula
- ClinicalTrials.gov ID
- NCT06429241
- Acronym / sponsor ID
- 2023-TH-SC01-I-007
- Conditions
- Anal Fistula, Complex Perianal Fistulas, Crohn's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 May 2024 (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 distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula
Detailed description
A Phase I clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSCs treatment group | Experimental | Biological: Mesenchymal Stem Cells (MSCs)Intralesional injection of expanded human umbilical cord-derived mesenchymal stem cells suspension. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 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 |
|---|---|---|
| Mesenchymal Stem Cells (MSCs)single dose injection (120 million cells) | Biological | MSCs treatment group |
Primary outcome
Standardized uptake value
Time frame: 8-12 hour、32-36 hour、56-60 hour、104-108 hour、152-156 hour，296-300 hour
Standardized values of organs or tissues after PET/CT imaging after local injection in patients with perianal fistula
3 secondary outcomes
Effectiveness endpoint:Proportion of subjects with clinically significant effect at week 24 after local injection
Time frame: Week 1，Week 4，Week 24
Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events
Time frame: 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.
Time frame: Week 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Miu Li Yan The First Affiliated Hospital of Soochow University contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal Stem Cells (MSCs) in people with Anal Fistula and 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 6 inclusion and 17 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 12 Jun 2024. 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 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.
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?
Contact Miu Li Yan The First Affiliated Hospital of Soochow University (86+0512-67972858, E-mail:sdfyec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value (time frame: 8-12 hour、32-36 hour、56-60 hour、104-108 hour、152-156 hour，296-300 hour). 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 12 Jun 2024.