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Crohn's DiseasePhase 1NCT04939337

A Study of TH-SC01 for Treating Complex Perianal Fistula in Perianal Crohn's Disease.

A Phase 1 study testing TH-SC01 in people with Crohn's Disease, run by Jinling Hospital, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to asses the efficacy and Safety of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Complex Perianal Fistula in Perianal Crohn's Disease. 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?
TH-SC01
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
12 Nov 2020to Aug 2024
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

  • 1. Signed Informed Consent；
  • 2. According to the Diagnostic Criterion for Crohn's Disease in China's 《Consensus on the Diagnosis and Treatment of Inflammatory Bowel Disease》 (2018, Beijing), Crohn's disease was diagnosed at least 6 months before the screening period；
  • 3. Crohn's disease activity index (CDAI) score of 220 or less is defined as inactive or mildly active luminal Crohn's disease；
  • 4. Through clinical evaluation, MRI evaluation for anal fistula patients；
  • 5. Age 18 ~ 70, male or female；
  • 6. The serum or urine pregnancy test of a woman of reproductive age must be negative. Both men and women must agree to use a contraceptive method；
  • 7. According to the history and related examination, the general health condition is good；
  • 8. The eligible patients must at least meet one of the following conditions: patients who have failed to respond to any conventional treatment, such as conventional antibiotic therapy, immunomodulatory drug therapy, anti-tumor necrosis factor (TNF) α monoclonal antibody therapy, and 5-aminosalicylic acid

Who cannot join

  • 1. CDAI > 220, or due to Crohn's disease activity, treatment needs to be upgraded immediately；
  • 2. Patients with abdominal and pelvic abscess or fistula diameter more than 2 cm；
  • 3. Patients with rectal and/or anal stenosis and/or active proctitis (due to limited surgical procedures)；
  • 4. The number of internal and / or external openings of anal fistula was more than 2 and 3 respectively;
  • 5. Patients who received steroid therapy within the first 4 weeks were screened；
  • 6. Abnormal laboratory test results： Liver function: total bilirubin ≥1.5 times the upper limit of normal value, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)≥2.5 times the upper limit of normal value; Renal function: Creatinine clearance below 60mL/min or 1.5 times the upper normal limit of serum creatinine (measured value or calculated by the Cockcroft-Gault formula)；
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  • 7.Patients with malignancy or a history of malignancy, including fistula cancer of any type；
  • 8. Patients with severe, progressive, uncontrollable diseases of the liver, blood, gastrointestinal (except Crohn's disease), endocrine, lung, heart, neurological, psychiatric, or brain；
  • 9. HIV, syphilis antibody positive, HCV / HBV positive, tuberculosis in the infectious period, etc;
  • 10. Patients who are allergic to human serum albumin, human platelet lysates, anesthetic agents or contrast agents；
  • 11. Patients with contraindications to MRI scanning；
  • 12. Pregnant or lactating women and subjects who cannot commit to using effective contraceptives during the trial and for 6 months after the end of the trial；
  • 13. Patients who have undergone major surgery or severe trauma in the past six months；
  • 14. Patients who had received any study drug within a certain period of time prior to screening；
  • 15.Patients deemed ineligible to participate in this clinical trial by the investigator

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jinling hospital

    Nanjing, Jiangsu, 210002

Other trials in China

About this study

Official title: Study to Assess the Safety and Efficacy of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells(TH-SC01), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.

The purpose of this study is to asses the efficacy and Safety of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Complex Perianal Fistula in Perianal Crohn's Disease.

Read the detailed description

Crohn´s disease (CD) can affect any part of the digestive system and symptoms of this chronic illness include abdominal pain, bloating, nausea, vomiting and diarrhea. CD also causes bowel wall ulcers, strictures and fistulas (abnormal passages from the intestines to another organ or the skin).

There is an unmet need for effective medical therapy in CD patients with perianal fistulas, not responding to the conventional strategies, including biological therapies. The current study is designed to assess the safety and efficacy of Allogeneic Umbilical Cord-derived Mesenchymal Stem cells from healthy donors for the treatment of perianal fistulas in patients presenting CD.

Primary objective: To assess the safety (incidence of treatment emergent adverse-events) of TH-SC01

Conditions
Crohn's Disease
Being tested
TH-SC01
Keywords
Complex Perianal Fistulas
Medical subject headings
Crohn Disease

What participants receive

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

  • TH-SC01Drug

    Allogeneic Umbilical Cord-derived Mesenchymal Stem cells perilesional injection. Human TH-SC01 cell injection (human umbilical cord mesenchymal stem cells for injection, 5 million cells / ml, 6.0-10.0ml / bottle)

Study groups in NCT04939337
Study groupRoleWhat they receive
TH-SC01ExperimentalTH-SC01 24 mL suspension of 120 million cells as a perilesional injection, once on Day 0.
Receives: Drug: TH-SC01

What is being measured

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

  1. Percentage of Participants who Achieve Combined Remission

    Combined remission is defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of abscess(es) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by central magnetic resonance imaging (MRI) assessment or transrectal ultrasonography(TRUS)

    Measured: 24 weeks

Secondary outcomes (6)

  1. Percentage of Participants who Achieve Clinical Remission

    Clinical remission is defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression.

    Measured: Up to Week 24

  2. Percentage of Participants who Achieve Clinical Response

    Clinical response is defined as closure of at least 50% of all treated external openings that were draining at baseline despite gentle finger compression.

    Measured: Up to Week 24

  3. Percentage of Participants who decrease in PDAI

    PDAI is a scoring system for assessing the severity of perianal lesions associated with Crohn's disease.It consists of the following five items :(a) perianal secretions;(b) Pain and movement;(c) Sexual life;(d) Perianal manifestations;(e) Sclerosing.Each item is rated on a five-point scale from asymptomatic (0) to severe (4), with an overall score of 0 to 20.The higher the score, the more severe the disease.

    Measured: 0、4、8、16、24 weeks

  4. Percentage of Participants who decrease in IBDQ

    IBDQ questionnaire score is used to investigate the quality of life of patients. There are 32 questions in total, and each question has 1 to 7 answers of different degrees, with 1 representing the most severe degree and 7 representing the least severe degree

    Measured: 0、4、8、16、24 weeks

  5. Percentage of Participants who decrease in VAS scale

    VAS scale was used to evaluate the pain. 0 points indicated no pain, less than 3 points indicated mild pain, 4-6 points indicated pain affecting sleep but tolerable, 7-10 points indicated pain and discomfort, affecting appetite and sleep. The higher number, the pain was more obvious.

    Measured: 0、4、8、16、24 weeks

  6. Percentage of Participants who decrease in Wexner incontinence score

    Wexner incontinence score

    Measured: 0、4weeks

Timeline

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

  1. First posted25 Jun 2021
  2. Study start12 Nov 2020
  3. Primary completionJan 2024 (estimated)
  4. Study completionAug 2024 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04939337
Sponsor's protocol ID
20181231
Status last verified
Jun 2021
First submitted
10 Jun 2021
Last updated
25 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thoreson R, Cullen JJ. Pathophysiology of inflammatory bowel disease: an overview. Surg Clin North Am. 2007 Jun;87(3):575-85. doi: 10.1016/j.suc.2007.03.001.

    PubMed 17560413

  • Wei J, Zhang Y, Chen C, Feng X, Yang Z, Feng J, Jiang Q, Fu J, Xuan J, Gao H, Liao L, Wang F. Efficacy and safety of allogeneic umbilical cord-derived mesenchymal stem cells for the treatment of complex perianal fistula in Crohn's disease: a pilot study. Stem Cell Res Ther. 2023 Oct 31;14(1):311. doi: 10.1186/s13287-023-03531-0.

    PubMed 37904247

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TH-SC01 in people with Crohn's Disease, run by Jinling Hospital, China 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 8 inclusion and 15 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 25 Jun 2021. 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?

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?

Percentage of Participants who Achieve 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 NCT04939337, which also lists 2 linked publications.

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 25 Jun 2021.

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