Early Phase 1 Crohn's Disease and Colitis Trial, By Invitation
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- The person has signed a consent form agreeing to take part in the trial.
- A doctor has confirmed a diagnosis of Crohn's disease at least 6 months before the screening visit, based on a recognised Chinese medical guideline for inflammatory bowel disease.
- The person's Crohn's disease activity score (CDAI) is 220 or below, meaning the disease is inactive or only mildly active.
- A complex anal fistula (an abnormal tunnel near the back passage) has been confirmed by both a physical examination and an MRI scan.
- The person is between 18 and 60 years old (inclusive), of any sex.
- Women who could become pregnant must have a negative pregnancy test before joining, and all participants must agree to use effective contraception during the trial and for 6 months after it ends.
- The person is in generally good health, as confirmed by their medical history and relevant check-ups.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- The person has a CDAI score above 220, or needs immediate treatment for active Crohn's disease.
- The person has narrowing of the rectum or back passage, or active inflammation of the rectum.
- The person has an abscess larger than 2 cm that has not been treated at least 2 weeks before the trial.
- The person has had previous fistula surgery (other than drainage or placement of a seton, which is a type of surgical thread), currently needs or is expected to need other surgery near the back passage within 24 weeks after treatment.
- The person has used steroid tablets or injections affecting the whole body within 4 weeks before the screening visit.
- The person has abnormal liver test results, specifically: total bilirubin 1.5 times or more above the normal upper limit, or liver enzyme levels (AST or ALT) 2.5 times or more above the normal upper limit.
- The person has abnormal kidney function, based on a low kidney filtration rate (below 60 mL/min) or a high creatinine level (1.5 times or more above the normal upper limit).
- The person has a current or past diagnosis of cancer, including any cancer related to the fistula.
- The person has a serious, worsening, or poorly controlled disease affecting the liver, blood, digestive system (other than Crohn's disease), hormonal system, lungs, heart, nerves, mental health, or brain.
- The person has tested positive for HIV or syphilis antibodies, has an active hepatitis B or C infection, or has active tuberculosis.
- The person has a known allergy to any antibiotics or materials used in the trial, including penicillin, streptomycin, gentamicin, aminoglycosides, human serum albumin, human platelet lysate, a cell culture solution called DMEM, or any products derived from cattle.
- The person cannot tolerate anaesthesia, or has a reason they cannot have an MRI scan, such as a pacemaker, a hip replacement, severe claustrophobia, or an allergy to the MRI contrast dye (gadolinium).
- The person is pregnant, breastfeeding, or is unwilling to use effective contraception during the trial and for 6 months after it ends.
- The person has had a major operation or serious physical injury within the past 6 months.
- The person has a history of alcohol or drug misuse in the 6 months before joining.
- The person has taken part in another medical trial and used an experimental drug within the 12 weeks (84 days) before screening.
- The person is unable to follow the trial's requirements, or the trial investigators consider them unsuitable for another reason (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
Primary endpoints
CD anal fistula healing rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.