Crohn's Disease With Perianal FistulasEarly Phase 1VH-MSC-CDAFNCT07113795
Clinical Study on the Integration of Traditional Chinese Medicine Virtual Hanging Therapy With Mesenchymal Stem Cells for the Treatment of Crohn's Disease-Associated Anal Fistula.
A Early Phase 1 study testing TCM dummy therapy combined with mesenchymal stem cell injection therapy, Dummy Line Therapy Group and MSC Group in people with Crohn's Disease With Perianal Fistulas, run by The Anorectal Center of Nanjing Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
To evaluate the efficacy and safety of TCM virtual hanging therapy combined with mesenchymal stem cellsin the treatment of CD anal fistula. To establish the standard of clinical diagnosis and treatment and thestandard procedure of operation for the treatment of CD anal fistula by virtual hanging therapy combinedwith… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Crohn's Disease With Perianal Fistulas
- What is being tested?
- TCM dummy therapy combined with mesenchymal stem cell injection therapy, Dummy Line Therapy Group and MSC Group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 2026
- Phase
- Early Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent form.
- Diagnosis of Crohn's disease (CD) confirmed at least 6 months prior to screening, based on the Chinese Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing).
- Crohn's Disease Activity Index (CDAI) score ≤220, indicating inactive or mildly active CD.
- Presence of complex anal fistula confirmed by clinical and MRI evaluation.
- Age 18-60 years (inclusive), regardless of sex.
- Negative serum/urine pregnancy test for women of childbearing potential; all participants must agree to use effective contraception during and for 6 months after the trial.
- Good general health status confirmed by medical history and relevant examinations.
Who cannot join
- CDAI >220 or requiring immediate treatment for active CD.
- Patients with rectal/anal stenosis or active proctitis (due to procedural limitations).
- Presence of abscess >2 cm unless treated ≥2 weeks prior to the trial.
- History of fistula surgery (except drainage or seton placement), concurrent need for perianal surgery unrelated to fistula, or anticipated need for such surgery within 24 weeks post-treatment.
- Systemic steroid therapy within 4 weeks prior to screening.
- Abnormal laboratory results:
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- Liver function: Total bilirubin ≥1.5×ULN; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5×ULN.
- Renal function: Creatinine clearance <60 mL/min or serum creatinine ≥1.5×ULN (measured or calculated by Cockcroft-Gault formula).
- Current or history of malignancy (including fistula-related carcinoma).
- Severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal (excluding CD), endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral diseases.
- HIV/syphilis antibody positivity, active HCV/HBV infection, or active tuberculosis.
- Known allergy to antibiotics or trial-related agents (e.g., penicillin, streptomycin, gentamicin, aminoglycosides, human serum albumin, human platelet lysate, DMEM cell culture medium, or bovine-derived materials).
- Intolerance to anesthesia or contraindications to MRI scanning (e.g., pacemaker, hip prosthesis, severe claustrophobia, gadolinium allergy).
- Pregnancy, lactation, or refusal to use effective contraception during and for 6 months post-trial.
- Major surgery or severe trauma within the past 6 months.
- History of alcohol/drug abuse within 6 months prior to enrollment.
- Use of investigational drugs within 12 weeks (84 days) prior to screening.
- Inability to comply with the study protocol or other conditions deemed unsuitable by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing Hospital of Traditional Chinese Medicine (Affiliated Hospital of Nanjing University of Chinese Medicine)
Nanjing, Jiangsu, 210000
About this study
Official title: Clinical Study on the Integration of Traditional Chinese Medicine Xu Gua Therapy With Mesenchymal Stem Cells for the Treatment of Crohn's Disease-Associated Anal Fistula.
To evaluate the efficacy and safety of TCM virtual hanging therapy combined with mesenchymal stem cellsin the treatment of CD anal fistula. To establish the standard of clinical diagnosis and treatment and thestandard procedure of operation for the treatment of CD anal fistula by virtual hanging therapy combinedwith mesenchymal stem cells.
- Being tested
- TCM dummy therapy combined with mesenchymal stem cell injection therapy, Dummy Line Therapy Group, MSC Group
- Keywords
- Traditional Chinese Medicine, Virtual Hanging therapy, Mesenchymal Stem Cells, Crohn's Disease-Associated Anal Fistula, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM dummy therapy combined with mesenchymal stem cell injection therapyProcedure or surgery
Combines TCM dummy therapy with mesenchymal stem cell injection, integrating traditional local stimulation and modern stem cell regenerative mechanisms.
Dummy Line Therapy GroupProcedure or surgery
Utilizes traditional thread-embedding techniques, placing specialized threads at specific sites to effectively drain inflammatory exudates and necrotic materials.
MSC GroupProcedure or surgery
Administers mesenchymal stem cell injections directly to target areas, leveraging their differentiation and anti-inflammatory properties to enhance tissue repair.
| Study group | Role | What they receive |
|---|---|---|
| Association Group | Experimental | receiving a combination of TCM dummy therapy and mesenchymal stem cell injection therapy Receives: Procedure: TCM dummy therapy combined with mesenchymal stem cell injection therapy |
| Dummy Line Therapy Group | Active comparator | treated solely with dummy line therapy Receives: Procedure: Dummy Line Therapy Group |
| MSC Group | Active comparator | administered only mesenchymal stem cell injection therapy Receives: Procedure: MSC Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD anal fistula healing rate
Post-treatment healing rate of Crohn's disease-related anal fistula, defined as clinical closure of all external fistula openings in patients, combined with MRI-confirmed fistula tract healing.
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (10)
CDAI
A clinical scoring system to quantify disease activity in Crohn's disease (CD) patients, integrating symptoms (e.g., abdominal pain, diarrhea) and laboratory parameters (e.g., hemoglobin, ESR).0~600(~600, theoretically no upper limit).Higher scores indicate worse disease activity (poorer outcome).
Measured: From enrollment to the end of treatment at 24 weeks
PDAI
A standardized tool to assess the severity of perianal complications (e.g., fistulas, abscesses) in Crohn's disease, combining clinical symptoms (e.g., pain, discharge) and imaging findings.0-20.Higher scores indicate worse perianal disease activity (poorer outcome).
Measured: From enrollment to the end of treatment at 24 weeks
IBDQ
A validated patient-reported outcome measure evaluating the quality of life in IBD patients across physical, emotional, and social domains.32-224.Higher scores indicate better health-related quality of life (better outcome).
Measured: From enrollment to the end of treatment at 24 weeks
Van Assche
An MRI-based scoring system for perianal fistulas, grading anatomical complexity (e.g., fistula branches, abscesses) and inflammatory activity to guide therapeutic strategies.0-12.Higher scores indicate more severe perianal fistulizing disease on MRI (poorer outcome).
Measured: From enrollment to the end of treatment at 24 weeks
VAS
A unidimensional pain assessment tool where patients mark their pain intensity on a 10-cm line (0=no pain, 10=worst pain).
Measured: From enrollment to the end of treatment at 24 weeks
Wexner
A validated scoring system to evaluate constipation severity based on stool frequency, straining, incomplete evacuation, and associated symptoms (e.g., abdominal bloating).0-20.Higher scores indicate worse fecal incontinence severity (poorer outcome).
Measured: From enrollment to the end of treatment at 24 weeks
Erythrocyte Sedimentation Rate (ESR)
A nonspecific inflammatory marker reflecting the rate at which red blood cells settle in a tube over one hour; elevated in infections, autoimmune diseases, or chronic inflammation.
Measured: From enrollment to the end of treatment at 24 weeks
Fecal Calprotectin
A stool biomarker of intestinal inflammation, reflecting neutrophil activity; used to differentiate inflammatory bowel disease (IBD) from functional gastrointestinal disorders.
Measured: From enrollment to the end of treatment at 24 weeks
C-reactive Protein (CRP)
An acute-phase protein synthesized by the liver; elevated serum levels indicate systemic inflammation, infection, or tissue damage.
Measured: From enrollment to the end of treatment at 24 weeks
Anorectal Manometry
Primary outcome measures: Anal Resting Pressure (basal sphincter pressure at rest; normal 40-80mmHg; <40mmHg=incontinence risk), Maximum Anal Squeeze Pressure (peak voluntary squeeze; normal 100-200mmHg; <100mmHg=sphincter impairment), Recto-anal Pressure Gradient (rectal-anal pressure difference; normal -20 to -50mmHg; positive=dyssynergic defecation). Secondary: First Sensation Volume (minimal rectal balloon volume for sensation; normal 10-30mL; >30mL=hyposensitivity), Urge Volume (volume for sustained defecation urge; normal 40-80mL; >80mL=severe sensory dysfunction), Max Rectal Volume (max tolerated distension; normal 120-200mL; <120mL=low compliance), Balloon Expulsion Time (time to expel 50mL balloon; normal ≤60s; >60s=pelvic dyssynergia), Anal High Pressure Zone Length (axial sphincter length; normal 2.0-4.0cm; <2.0cm=anatomical defect).
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jul 2022
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's Disease With 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Anorectal Center of Nanjing Hospital of Traditional Chinese Medicine
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113795
- Sponsor's protocol ID
- BE2022674
- Acronym
- VH-MSC-CDAF
- Status last verified
- Aug 2025
- First submitted
- 19 May 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single-center study without involvement of other institutions.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Integration of Traditional Chinese Medicine Xu Gua Therapy With Mesenchymal Stem Cells for the Treatment of Crohn's Disease-Associated Anal Fistula.
- ClinicalTrials.gov ID
- NCT07113795
- Acronym / sponsor ID
- VH-MSC-CDAF / BE2022674
- Keywords
- Traditional Chinese Medicine, Virtual Hanging therapy, Mesenchymal Stem Cells, Crohn's Disease-Associated Anal Fistula, Randomized Controlled Trial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Anorectal Center of Nanjing Hospital of Traditional Chinese MedicineResearch network
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Aug 2025 (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.
To evaluate the efficacy and safety of TCM virtual hanging therapy combined with mesenchymal stem cellsin the treatment of CD anal fistula. To establish the standard of clinical diagnosis and treatment and thestandard procedure of operation for the treatment of CD anal fistula by virtual hanging therapy combinedwith mesenchymal stem cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Association Group | Experimental | Procedure: TCM dummy therapy combined with mesenchymal stem cell injection therapyreceiving a combination of TCM dummy therapy and mesenchymal stem cell injection therapy |
| Dummy Line Therapy Group | Active comparator | Procedure: Dummy Line Therapy Grouptreated solely with dummy line therapy |
| MSC Group | Active comparator | Procedure: MSC Groupadministered only mesenchymal stem cell injection therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent form.
- Diagnosis of Crohn's disease (CD) confirmed at least 6 months prior to screening, based on the Chinese Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing).
- Crohn's Disease Activity Index (CDAI) score ≤220, indicating inactive or mildly active CD.
- Presence of complex anal fistula confirmed by clinical and MRI evaluation.
- Age 18-60 years (inclusive), regardless of sex.
Key exclusion criteria (18 listed)
- CDAI >220 or requiring immediate treatment for active CD.
- Patients with rectal/anal stenosis or active proctitis (due to procedural limitations).
- Presence of abscess >2 cm unless treated ≥2 weeks prior to the trial.
- History of fistula surgery (except drainage or seton placement), concurrent need for perianal surgery unrelated to fistula, or anticipated need for such surgery within 24 weeks post-treatment.
- Systemic steroid therapy within 4 weeks prior to screening.
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 |
|---|---|---|
| TCM dummy therapy combined with mesenchymal stem cell injection therapyCombines TCM dummy therapy with mesenchymal stem cell injection, integrating traditional local stimulation and modern stem cell regenerative mechanisms. | Procedure or surgery | Association Group |
| Dummy Line Therapy GroupUtilizes traditional thread-embedding techniques, placing specialized threads at specific sites to effectively drain inflammatory exudates and necrotic materials. | Procedure or surgery | Dummy Line Therapy Group |
| MSC GroupAdministers mesenchymal stem cell injections directly to target areas, leveraging their differentiation and anti-inflammatory properties to enhance tissue repair. | Procedure or surgery | MSC Group |
Primary outcome
CD anal fistula healing rate
Time frame: From enrollment to the end of treatment at 24 weeks
Post-treatment healing rate of Crohn's disease-related anal fistula, defined as clinical closure of all external fistula openings in patients, combined with MRI-confirmed fistula tract healing.
10 secondary outcomes
CDAI
Time frame: From enrollment to the end of treatment at 24 weeks
PDAI
Time frame: From enrollment to the end of treatment at 24 weeks
IBDQ
Time frame: From enrollment to the end of treatment at 24 weeks
Van Assche
Time frame: From enrollment to the end of treatment at 24 weeks
VAS
Time frame: From enrollment to the end of treatment at 24 weeks
Wexner
Time frame: From enrollment to the end of treatment at 24 weeks
Erythrocyte Sedimentation Rate (ESR)
Time frame: From enrollment to the end of treatment at 24 weeks
Fecal Calprotectin
Time frame: From enrollment to the end of treatment at 24 weeks
C-reactive Protein (CRP)
Time frame: From enrollment to the end of treatment at 24 weeks
Anorectal Manometry
Time frame: From enrollment to the end of treatment at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No. This is a single-center study without involvement of other institutions.
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.
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 Early Phase 1 study testing TCM dummy therapy combined with mesenchymal stem cell injection therapy, Dummy Line Therapy Group and MSC Group in people with Crohn's Disease With Perianal Fistulas, run by The Anorectal Center of Nanjing Hospital of Traditional Chinese Medicine 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 18 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
CD anal fistula healing rate (time frame: From enrollment to the end of treatment at 24 weeks). 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 11 Aug 2025.