Using stem cell transplants to treat Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of autologous stem cell transplantation combined with immunosuppressive drugs to treat patients with Crohn's disease who have not responded to conventional therapies. The study aims to achieve remission in patients suffering from active disease characterized by significant gastrointestinal inflammation. By utilizing hematopoietic stem cell transplantation, the researchers hope to reset the immune system and improve long-term outcomes for these patients. The trial will assess the effectiveness of this approach in achieving and maintaining remission.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:

  1. corticosteroids
  2. azathioprine,
  3. 6-mercaptopurine, methotrexate
  4. Anti-TNFα (infliximab, adalimumab, certolizumab, golimumab)
  5. Anti-integrin agents (natalizumab, vedolizumab)
  6. Ustekinumab
* 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 Criteria:

* 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.

Where it's running

• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Aaron Etra, MD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Louis Cohen, MD
• Email: louis.cohen@mssm.edu
• Phone: (212) 241-8100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Microencapsulated Propionate vs Butyrate for Crohn's Disease in Remission

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• Laser-based sizing of GI lesions during endoscopies

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• Claudin-2 Immunostaining to Detect Active or Inactive Inflammation in IBD Biopsies

  This study tests whether staining for Claudin-2 in intestinal biopsy samples can help identify active vs. inactive inflammation in people with ulcerative colitis or Crohn's disease.

  Recruiting IRCCS Policlinico S. Donato · San Donato Milanese, Mi · NCT07710287

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.