High-Dose Chemotherapy and Stem Cells for Crohn's Disease

Autologous Stem Cell Transplantation for Crohn's Disease

Recruiting Phase 1 Phase 2 Interventional Study
Crohn's Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
10 – 60
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Paul Szabolcs · Other
Who this trial is looking for

This trial is looking for adults and kids with severe Crohn's disease. Participants will receive high-dose chemotherapy followed by a stem cell infusion to see if it helps their condition.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 10 and 60 years old.
  • I have been diagnosed with severe Crohn's disease.
  • I understand and can give my consent to join the trial.
  • I have a high Harvey Bradshaw Index (HBI) or Crohn's Disease Activity Index (CDAI) score.
  • I cannot have surgery due to high risks.
  • I have tried intense medical treatment without success.
  • I have certain complications from Crohn's disease that do not respond to treatment.
  • I have a platelet count greater than 100,000.

You may not be able to join if

  • I have not taken enough medication for my Crohn's disease.
  • I have had serious problems like toxic megacolon or intestinal perforation.
  • I am currently pregnant or nursing.
  • I have active infections.
  • I have certain liver issues.
  • I have had successful treatments with TNF alpha inhibitors or related therapies.
  • I am HIV or hepatitis positive.
  • I have other medical problems that may interfere with the study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

The objective of this study is to evaluate the safety and effectiveness of administering high-dose chemotherapy followed by infusion of autologous CD34-selected peripheral blood stem cells (PBSC) in pediatric and adult patients with severe Crohn's disease.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
5.1 Inclusion Criteria 1. Subject and/or guardian must be able to understand and provide informed consent. 2. Male or female, 10 through 60 years old, inclusive at time of informed consent. 3. Examples of subjects for whom stem cell transplant therapy would be appropriate include, but are not limit…
Contacts

Shawna H McIntyre, RN

412-692-5552

mcintyresm@upmc.edu

CONTACT