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Stem Cell Transplantation
Stem Cell Transplant for Crohn's Disease
Phase 1 & 2
Recruiting
Led By Paul Szabolcs, MD
Research Sponsored by Paul Szabolcs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females ≥ 10 years old or who have reached menarche must have a negative pregnancy test and agree to use FDA approved birth control
Male or female, 10 through 60 years old, inclusive at time of informed consent
Must not have
Toxic megacolon, intestinal perforation
Patients who have not been treated with adequate dosing of 6-MP, 5-ASA products and metronidazole
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether high-dose chemotherapy followed by infusion of autologous CD34-selected peripheral blood stem cells is safe and effective in treating Crohn's disease.
Who is the study for?
This trial is for pediatric and adult patients aged 10-60 with severe Crohn's disease who haven't responded to aggressive medical treatments or can't have surgery without risking short bowel syndrome. Participants must understand the consent process, not be pregnant, agree to use birth control post-transplant, and meet specific health criteria like adequate blood counts and organ function.
What is being tested?
The study tests high-dose chemotherapy followed by an infusion of the patient's own CD34-selected peripheral blood stem cells. The goal is to assess if this approach is safe and effective in treating severe Crohn's disease that hasn’t improved with standard therapies.
What are the potential side effects?
Potential side effects may include reactions from high-dose chemotherapy such as nausea, hair loss, mouth sores, increased risk of infections due to low blood cell counts, organ inflammation from immune responses, fatigue, and potential infertility.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a female over 10 or have started my periods, not pregnant, and agree to use birth control.
Select...
I am between 10 and 60 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a severely swollen colon or a tear in my intestine.
Select...
I haven't been treated with standard doses of 6-MP, 5-ASA, or metronidazole.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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: 1Experimental Treatment9 Interventions
High-dose immunotherapy followed by infusion of autologous CD34-selected peripheral blood stem cells (PBSC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesna
2003
Completed Phase 2
~1380
Rituximab
1999
Completed Phase 4
~2990
Cyclophosphamide
2010
Completed Phase 4
~2310
G-CSF
2014
Completed Phase 4
~1610
Alemtuzumab
2004
Completed Phase 4
~1880
ATG
2016
Completed Phase 4
~1070
Melphalan
2008
Completed Phase 3
~1500
Thiotepa
2008
Completed Phase 3
~2120
Find a Location
Who is running the clinical trial?
Paul SzabolcsLead Sponsor
7 Previous Clinical Trials
212 Total Patients Enrolled
Paul Szabolcs, MDPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
7 Previous Clinical Trials
209 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe Crohn's disease not responding to treatment and might need a stem cell transplant.I am a female over 10 or have started my periods, not pregnant, and agree to use birth control.I have responded to treatment without needing steroids continuously.I have not had a severely swollen colon or a tear in my intestine.I am between 10 and 60 years old.I haven't been treated with standard doses of 6-MP, 5-ASA, or metronidazole.I have not had an infection within two weeks before my intense cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.