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Stem Cell Transplant Agent

Vedolizumab Post-Stem Cell Transplant for Crohn's Disease

Phase 2
Recruiting
Led By Amir Steinberg, MD
Research Sponsored by Aaron Etra
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No surgical therapeutic option secondary to risk of short bowel syndrome or patient refusal
Diagnosis of Crohn's disease by standard criteria
Must not have
Ejection fraction <30% or requiring supplemental continuous oxygen
DLCO <35% or requiring supplementary oxygen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 year post transplant
Awards & highlights
No Placebo-Only Group
Approved for 50 Other Conditions
All Individual Drugs Already Approved

Summary

This trial is testing whether the drug Vedolizumab can help improve remission for Crohn's Disease patients who have had a hematopoietic stem cell transplant.

Who is the study for?
This trial is for adults with active Crohn's Disease who haven't responded to standard treatments like corticosteroids, immunosuppressants, or biologics. They should not have heart, lung issues (like needing extra oxygen), HIV, a history of bad reactions to the trial drugs, be pregnant/breastfeeding, or too sick to do daily activities.
What is being tested?
The study tests if combining an autologous stem cell transplant with drugs like Thymoglobulin and Cyclophosphamide followed by Vedolizumab can help achieve and maintain remission in Crohn's Disease. It involves hospital stays for chemotherapy and monitoring after the transplant.
What are the potential side effects?
Possible side effects include reactions to medication infusions, increased risk of infections due to immune suppression from chemotherapy and stem cell transplant procedures. There may also be general side effects from high-dose steroids like Methylprednisolone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cannot have surgery due to the risk of severe digestive issues or because I chose not to.
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I have been diagnosed with Crohn's disease.
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My bowel disease is active, as confirmed by a specific test.
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My Crohn's disease is active, with a CDAI score over 250.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's pumping ability is very weak or I need extra oxygen all the time.
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My lung function is severely reduced or I need extra oxygen.
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I need assistance with my daily activities.
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I have heart problems that are not well-managed.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 1 year post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 year post transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Crohn's Disease Activity Index (CDAI)
Secondary study objectives
Change in endoscopic activity indices
Other study objectives
Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Change in burden of intestinal disease

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 50 Other Conditions
This treatment demonstrated efficacy for 50 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment5 Interventions
Hematopoietic Stem Cell Transplant followed by maintenance Vedolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antithymocyte immunoglobulin (rabbit)
FDA approved
Cyclophosphamide
FDA approved
Vedolizumab
FDA approved
Autologous stem cell transplant
2010
Completed Phase 2
~130
Methylprednisolone
FDA approved

Find a Location

Who is running the clinical trial?

Aaron EtraLead Sponsor
Icahn School of Medicine at Mount SinaiLead Sponsor
913 Previous Clinical Trials
572,751 Total Patients Enrolled
Amir Steinberg, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Aaron Etra, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Louis Cohen, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Autologous stem cell transplant (Stem Cell Transplant Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03219359 — Phase 2
Crohn's Disease Research Study Groups: Experimental
Crohn's Disease Clinical Trial 2023: Autologous stem cell transplant Highlights & Side Effects. Trial Name: NCT03219359 — Phase 2
Autologous stem cell transplant (Stem Cell Transplant Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03219359 — Phase 2
~7 spots leftby Apr 2026
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