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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post bone marrow transplant
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post bone marrow transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post bone marrow transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change and duration in the Crohn's Disease Activity Index (CDAI).
Change and duration in the Harvey Bradshaw Index (HBI).
Change and duration in the Pediatric Crohn's Disease Activity Index (PCDAI).
+2 more
Secondary outcome measures
Biomarker identification for relapse
Number of days it takes for Absolute Neutrophil Count (ANC) to reach greater than 500.
Number of days it takes for Platelet count to reach greater than 20,000/mm3
+4 more

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
Cyclophosphamide
1995
Completed Phase 3
~3780
G-CSF
2014
Completed Phase 4
~1610
Mesna
2003
Completed Phase 2
~1380
Alemtuzumab
2004
Completed Phase 4
~1890
ATG
2016
Completed Phase 4
~1060
Melphalan
2008
Completed Phase 3
~1500
Thiotepa
2008
Completed Phase 3
~2150
Rituximab
1999
Completed Phase 4
~1880

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

Autologous CD34-selected peripheral blood stem cells transplant (Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT00692939 — Phase 1 & 2
Crohn's Disease Research Study Groups: 1
Crohn's Disease Clinical Trial 2023: Autologous CD34-selected peripheral blood stem cells transplant Highlights & Side Effects. Trial Name: NCT00692939 — Phase 1 & 2
Autologous CD34-selected peripheral blood stem cells transplant (Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00692939 — Phase 1 & 2

Frequently Asked Questions

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

Could I potentially qualify to participate in this experiment?

"To be eligible for inclusion in this experiment, participants must have ileocolitis and fall within the 10 to 60 age range. There are 20 positions available at present."

Answered by AI

Is there an opportunity to join this clinical experiment at present?

"According to the data posted on clinicaltrials.gov, this medical experiment is currently enlisting participants and has been since June 26th 2012 with its most recent update occurring February 9th 2022."

Answered by AI

What conditions is autologous CD34-selected peripheral blood stem cells transplant traditionally used to treat?

"Autologous CD34-selected peripheral blood stem cells transplant can be utilized to treat multiple sclerosis, polyangium and b-cell lymphomas."

Answered by AI

What findings have been revealed in other investigations regarding autologous CD34-selected peripheral blood stem cell transplant?

"Currently, 1272 medical trials are underway to assess the efficacy of autologous CD34-selected peripheral blood stem cells transplant. Of those studies in progress, 249 have entered Phase 3. While many experiments for this treatment originate from Philadelphia, Pennsylvania, 39401 other sites worldwide are conducting research as well."

Answered by AI

Is eligibility for the experiment open to individuals who are older than fifty-five?

"This clinical trial requires participants between the ages of 10 and 60. For those under 18, there are 451 trials available; for those over 65, 1198 trails exist."

Answered by AI

How many participants has this trial enrolled thus far?

"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial, which was first publicized on June 26th 2012, is currently recruiting individuals for the study. A total of 20 people must be recruited from 2 separate medical sites."

Answered by AI
~2 spots leftby Dec 2025