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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body Weight Changes

Change in clinical measures of sustained remission

Change in erythrocyte sedimentation rate (SED rate)

+4 more

Secondary outcome measures

Change in T-cell repertoire after HSCT using spectratyping

Change in quality of life

Change in school and work productivity

+1 more

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: Stem cell mobilization Leukopheresis Preparative regimen Peripheral blood stem cell infusion Post-PBSC infusion conditioning

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peripheral Blood Stem Cell Infusion

2010

Completed Phase 2

~80

Mesna

2003

Completed Phase 2

~1380

Filgrastim

2000

Completed Phase 3

~3670

Cyclophosphamide

1995

Completed Phase 3

~3770

Methylprednisolone

2015

Completed Phase 4

~2280

Acetaminophen

2017

Completed Phase 4

~2030

Leukapheresis

2016

Completed Phase 2

~690

Cytoxan

2007

Completed Phase 3

~1460

Fludarabine

2012

Completed Phase 3

~1100

Diphenhydramine

2002

Completed Phase 4

~1170

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

500 Previous Clinical Trials

164,848 Total Patients Enrolled

David Ziring, MDPrincipal Investigator - Cedars-Sinai Medical Center

Cedars-Sinai Medical Center, Ronald Reagan UCLA Medical Center

Finch U Of Hs/Chicago Medical Sch (Medical School)

Ucla School Of Medicine (Residency)

1 Previous Clinical Trials

3 Total Patients Enrolled

Media Library

Peripheral Blood Stem Cell Infusion (Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT04224558 — Phase 1 & 2

Crohn's Disease Research Study Groups: HSCT after mobilization and conditioning

Crohn's Disease Clinical Trial 2023: Peripheral Blood Stem Cell Infusion Highlights & Side Effects. Trial Name: NCT04224558 — Phase 1 & 2

Peripheral Blood Stem Cell Infusion (Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04224558 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some popular indications for lymphocyte immune globulin?

"Lymphocyte immune globulin can be used to ameliorate the conditions of pain, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."

Answered by AI

What is the past research on lymphocyte immune globulin?

"There are currently 1234 active studies and 242 trials in Phase 3 for lymphocyte immune globulin. The majority of these trials are based in Taichung, Florida; however, there are a total of 34538 locations running studies for lymphocyte immune globulin."

Answered by AI

Are researchers currently looking for participants in this trial?

"The listing on clinicaltrials.gov verifies that this study is still open to enrolling patients. This research project was first posted on December 15th 2020, and has been updated as recently as March 23rd 2022. So far, 15 people have been enrolled at a single site."

Answered by AI

To whom does this research project offer inclusion?

"This clinical trial is looking for 15 patients between the ages of 13 and 28 who have ileocolitis. In addition to meeting this age requirement, patients must also be prepared to undergo additional study procedures, have an elevated CRP, and have unsatisfactory results from previous immunosuppressive treatments (such as azathioprine, methotrexate, and infliximab). Patients should also have relapsing disease despite thiopurine, methotrexate, and/or infliximab maintenance therapy or clear evidence of intolerance or toxicity to these drugs. Finally, patients must be accepted by a majority"

Answered by AI

What are researchers hoping to discover through this clinical trial?

"The primary outcome of this trial is to measure the change in C reactive protein (CRP) levels over a period of 2, 4, 6, 12, and 24 months post HSCT. Secondary outcomes include Change in school and work productivity, as well as Change in thymopoiesis after HSCT. These will be measured using the modified Work Productivity and Activity Impairment (WPAI) Index score and spectratyping respectively."

Answered by AI

How many individuals are included in this clinical trial?

"That is accurate. According to the listings on clinicaltrials.gov, this experiment was first posted on December 15th 2020 and is still recruiting patients. They need a total of 15 individuals from 1 location."

Answered by AI