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Stem Cell Transplantation

Stem Cell Transplant for Crohn's Disease

Phase 1 & 2

Recruiting

Led By David Ziring, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 2, 4, 6, 12 and 24 months post hsct

Awards & highlights

No Placebo-Only Group

Summary

This trial is for people with Crohn's disease who haven't responded to other treatments. It removes their lymphocytes and replaces them with stem cells from their own body.

Who is the study for?

This trial is for young people aged 13-28 with severe Crohn's Disease, who haven't responded well to at least three immunosuppressive drugs and steroids. They must have active disease, be informed about the risks, and not suitable for surgery or at risk of short bowel syndrome. Pregnant individuals or those unwilling to use contraception are excluded.

What is being tested?

The study tests 'high dose immunoablation' followed by autologous hematopoietic stem cell transplantation (HSCT) in patients with Crohn's Disease. It aims to reset the immune system by removing overactive lymphocytes and replacing them with the patient's own blood stem cells.

What are the potential side effects?

Potential side effects include reactions from catheter placement, infusion-related issues, bone marrow suppression due to chemotherapy drugs like Cyclophosphamide and Fludarabine, steroid-related side effects from Methylprednisolone, allergic reactions to medications such as Diphenhydramine or anti-thymocyte globulin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 2, 4, 6, 12 and 24 months post hsct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 2, 4, 6, 12 and 24 months post hsct

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 2, 4, 6, 12 and 24 months post hsct for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Weight Changes

Change in clinical measures of sustained remission

Change in erythrocyte sedimentation rate (SED rate)

+4 more

Secondary study objectives

Change in T-cell repertoire after HSCT using spectratyping

Change in quality of life

Change in school and work productivity

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HSCT after mobilization and conditioningExperimental Treatment13 Interventions

Mobilization and leukopheresis allow for stem cell harvest. Then conditioning is provided prior to stem cell transplantation, followed by post-transplant conditioning. Interventions include: 1. Stem cell mobilization 2. Leukopheresis 3. Preparative regimen 4. Peripheral blood stem cell infusion 5. Post-PBSC infusion conditioning

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetaminophen

2017

Completed Phase 4

~2030

Cytoxan

2007

Completed Phase 3

~1460