TerminatedPhase 1

Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease

Stopped: PI left institution

United States6 participantsStarted 2021-04-01

Plain-language summary

This study plans to enroll 10 patients aged 13-17 years of age with refractory perianal fistulizing disease. Patients will be treated by direct injection to the fistula tract(s) with 75 million allogeneic bone marrow derived mesenchymal stem cells at baseline and again after 3 months if not completely healed.

Who can participate

Age range

13 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males and females aged 13-17 with a diagnosis of Crohn's disease for at least six months duration.
. Single and Multi-tract Perianal fistula, with or without previous failed surgical repair.
. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
. Ability to comply with protocol
. Competent and able to provide written informed consent
. Concurrent Crohn's-related therapies with stable doses corticosteroids, 5- ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin therapies are permitted.
. Agree to use birth control or abstinence to avoid pregnancy during the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment related adverse events

Timeframe: Month 3

Treatment related adverse events

Timeframe: Month 12

Trial details

NCT IDNCT04791878

SponsorAnthony Lembo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

View on ClinicalTrials.gov More Perianal Fistula Due to Crohn's Disease (Disorder) trials

Plain-language summary

Who can participate

Age range

13 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males and females aged 13-17 with a diagnosis of Crohn's disease for at least six months duration.
. Single and Multi-tract Perianal fistula, with or without previous failed surgical repair.
. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
. Ability to comply with protocol
. Competent and able to provide written informed consent
. Concurrent Crohn's-related therapies with stable doses corticosteroids, 5- ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin therapies are permitted.
. Agree to use birth control or abstinence to avoid pregnancy during the study

Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria