Phase 3 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have signed a consent form agreeing to participate in the trial
• People who have been diagnosed with Crohn's disease for at least 6 months, according to specific Chinese medical guidelines
• People whose Crohn's disease is not currently active in the gut (based on a scoring system called CDAI), but who do have an active perianal fistula (an abnormal tunnel near the back passage)
• People with no more than 2 internal fistula openings and no more than 3 external openings, confirmed by physical examination and MRI scan
• People who are fully active or have only minor limitations in daily physical activity (based on a standard medical scoring scale called ECOG, score 0–1)
• People considered to be in generally good health or with only mild health concerns for the purposes of anaesthetic risk (ASA grade I or II)
• People (and their partners) who are not planning to have a child during the trial period and agree to use effective non-hormonal contraception throughout

Who may not be able to join:

• People with known allergies to human serum albumin, human platelet lysate, gentamicin sulfate, anaesthetic drugs, or MRI contrast dye
• People who currently have an active infection, as judged by the trial doctor
• People whose Crohn's disease is currently active, or who have not finished their required initial treatment phase before the study drug is given
• People who have an abscess or fluid collection larger than 2 cm near the affected area
• People who have significant narrowing of the rectum or anal canal that would prevent any surgical procedure
• People who currently have active inflammation of the rectum (proctitis)
• People who have other types of fistulas, such as those connecting the rectum or anal canal to the vagina or bladder
• People who have had a stoma (a surgically created opening in the abdomen to divert the bowel) in the past, unless the stoma was fully reversed at least one month before the study drug is given
• People who are planning to have surgery in the perianal area during the trial for any reason other than the anal fistula being studied
• People whose blood test results show that liver or kidney function is outside the acceptable range specified by the trial (confirm specific values with trial site)
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis
• People who have or have previously had cancer
• People who have an immune system that does not work properly, whether from birth or due to illness
• People who cannot have an MRI scan for any reason
• People with a current or recent history of serious, uncontrolled conditions affecting the liver, blood, digestive system (other than Crohn's disease), hormones, lungs, heart, nervous system, or mental health
• People who have received stem cell treatment within the two years before joining the trial
• People who are currently taking steroids or have taken steroids in the past 4 weeks
• People who have had major surgery (such as orthopaedic or abdominal surgery) within one month before the study drug is given, or who plan to have surgery during the trial (other than procedures required by the trial itself)
• People with a history of drug misuse or heavy alcohol use, based on specific intake levels defined by the trial (confirm details with trial site)
• People who are pregnant or breastfeeding
• People with a history of a stoma, unless it was fully reversed at least one month before the study drug is given (confirm with trial site, as this overlaps with a separate criterion)
• People whom the trial doctor considers unsuitable for any other reason, including concerns about ability to attend follow-up appointments

Important: Always verify eligibility with the trial site directly before applying.