Back to search results

Autologous Stem Cell Transplant for Crohn's Disease

This study is looking at an autologous stem cell transplant (a procedure using your own stem cells) to treat Crohn's disease. Researchers want to see if this treatment can improve symptoms for people whose Crohn's disease hasn't responded well to other therapies. The transplant involves several medications: Cyclophosphamide, Thymoglobulin, and Methylprednisolone. To join, you must have Crohn's disease that is currently active, with a Crohn's Disease Activity Index (CDAI) score over 250. The study plans to enroll 50 participants. Success will be measured by changes in your CDAI score one year after the transplant. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 50 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your Crohn's Disease Activity Index (CDAI) will be measured at baseline and one year after the transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03219359

Autologous Stem Cell Transplant for Crohn's Disease

Recruiting
PHASE2Ages 18+InterventionalTreatment
Aaron Etra
~50 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Autologous stem cell transplantCyclophosphamideThymoglobulinMethylprednisoloneVedolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Crohn's Disease Activity Index (CDAI)
Measured over baseline and 1 year post transplant

Conditions

Crohn Disease

Explore related trials

Crohn Disease

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Aaron Etra, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Louis Cohen, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Louis Cohen, MD
[email protected]
(212) 241-8100
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Diagnosis of Crohn's disease by standard criteria
Active disease based on clinical symptoms, defined as CDAI \>250. In patients with an ostomy, the number of liquid stools score in the CDAI will be replaced by the number of times that the ostomy bag is emptied daily.
Active disease based on endoscopic evaluation, defined as SES-CD score \> 3 in at least one bowel segment
Failure to respond to (or intolerant/adverse reaction to or declines) a member of each of the class of drugs listed below:
Failure to respond refers to ongoing objective inflammation with symptoms and, as is traditional, is defined by the gastroenterologist evaluating the patient.
No surgical therapeutic option secondary to risk of short bowel syndrome or patient refusal

Exclusion

History of significant toxicity to any medications used in trial (cyclophosphamide, thymoglobulin, vedolizumab)
Pregnant or breastfeeding
Age \<18
Karnofsky Performance Score \<60
Patients who have an uncontrolled infection (presumed or documented) despite appropriate therapy for at least one month
Patients with symptomatic coronary artery disease or uncontrolled congestive heart failure.
HIV infected
Ejection fraction \<30% or requiring supplemental continuous oxygen.
DLCO \<35% or requiring supplementary oxygen.
Patients for whom an insufficient number of stem cells (\<2 X 10\^6/kg) have been collected.

What this trial measures

  • Change in Crohn's Disease Activity Index (CDAI)baseline and 1 year post transplant

    The proportion of patients in clinical remission, defined as a CDAI \< 150, one year after autologous HCT from 45% to 65% as compared to baseline.