Phase 1 Crohn's Disease and Colitis Trial, Recruiting NCT05039411 Sponsor: CryoCord Sdn Bhd Condition: Crohn's Disease and Colitis
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Phase 1 Crohn's Disease and Colitis Trial, Recruiting

NCT05039411
Recruiting Phase 1

Who may 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 might be able to join this trial:

  • Adults aged 18 years or older.
  • People who have been diagnosed with perianal fistulas (abnormal tunnels near the anus) linked to Crohn's disease that have not responded to medical treatment.
  • People whose fistula has no more than 2 internal openings and no more than 3 external openings, as assessed by a doctor.
  • People who are considered medically suitable for surgery.

Who may not be able to join:

  • People who do not agree to give informed consent to take part.
  • People who are pregnant or breastfeeding.
  • People who currently have an active cancer diagnosis, or whose cancer has been in remission for less than 5 years.
  • People who have signs of active, serious infection or widespread infection in the body.
  • People who have HIV, hepatitis B, hepatitis C, or syphilis (treponema infection), whether currently active or dormant (latent).
  • People who have documented allergies (confirm with trial site for which allergies apply).
  • People who have received infliximab or any other biologic medications within the 4 weeks before the cell treatment is given.
  • People who are currently taking, or who have taken within 1 month before enrolling, any other experimental drug as part of another trial.
  • People who have other health conditions that a doctor considers would make stem cell treatment unsafe, such as active infection or current steroid use.

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: April Camilla Roslani, Prof. Dr., Department of Surgery, Faculty of Medicine, University of Malaya

Phone: +603-7949 2050

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
CryoCord Sdn Bhd
Registry
ClinicalTrials.gov
Start date
1 March 2022
Est. completion
31 December 2026

Where this trial is recruiting

🇲🇾 Malaysia

Primary endpoints

No incidence of treatment-emergent adverse events (TEAEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov