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TerminatedNCT00278577Updated Feb 6, 2014

Hematopoietic Stem Cell Support in Patients With Severe Crohn's Disease

A Phase 1 interventional study of Immune Ablation and Hematopoietic Stem Cell Support in CROHN'S DISEASE, sponsored by Richard Burt, MD. Terminated at 1 site in United States. Open to participants aged Up to 60 Years. Per ClinicalTrials.gov, last updated 2014-02-06.

Sponsored by Richard Burt, MD · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
Up to 60 Years
Sex
All
01

Study summary

This disease is believed to be caused by immune cells (called lymphocytes) attacking tissue. Risk of death is highest in people with active acute disease. In addition, progressive Crohn's Disease leads to further loss of bowel function, which may eventually result in the need for artificial nutritional support (parenteral nutrition).

This study involves high dose chemotherapy followed by return (infusion) of blood stem cells. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The high dose chemotherapy consists of cyclophosphamide and anti lymphocyte antibody (a protein that depletes cells that cause damage to the body). The purpose of the intense chemotherapy is to destroy the immune system completely. The purpose of the stem cell infusion is to restore the body's blood production, which will be severely impaired by the high dose chemotherapy and anti lymphocyte antibody.

02

Conditions studied

  • CROHN'S DISEASE

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 25 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Richard Burt, MD is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Less than physiologic age 60 at time of pretransplant evaluation
  2. An established clinical diagnosis of severe CD that has failed therapy with prednisone, azathioprine, 5 ASA products and metronidazole, and has failed an anti-TNF alpha inhibitor. Failure is defined as a CDAI (appendix A) 250-400 or a Craig Severity Score that is > 17 (appendix D)
  3. Pre-study peripheral blood counts must include a platelet count greater than 100,000/ul and an absolute neutrophil count greater than 1500/ul.
  4. Stem cell harvest greater than 1.4 x 106 CD34 cells/kg after CD34+ selection (to continue to transplant)
  5. Ability to give informed consent

Exclusion criteria

Exclusion Criteria

  1. HIV positive
  2. History of coronary artery disease, or congestive heart failure
  3. Uncontrolled diabetes mellitus, or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy
  4. Prior history of malignancy except localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as head and neck cancer, or stage I breast cancer will be considered on an individual basis
  5. Positive pregnancy test, lactation, inability or unwillingness to pursue effective means of birth control, failure to accept or comprehend irreversible sterility as a side effect of therapy
  6. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
  7. FEV I/FVC \< 50% of predicted, DLCO \< 50% of predicted
  8. Resting LVEF \< 40%
  9. Bilirubin > 2.0 mg/dl, transferase (AST) > 2x upper limit of normal, unless the abnormalities are secondary to Crohn's disease
  10. Serum creatinine > 2.0 mg/dl
  11. Platelet count less than 100,000/ul, ANC less than 1500/ul
  12. Patients presenting with intestinal perforation or toxic megacolon, or a suppurative problem that will require urgent surgery. In addition, the patient may not have any active infection. The presence of intestinal stomas does not exclude the patient from study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Autologous Hematopoietic Stem Cell Transplant

    Biological: Immune Ablation and Hematopoietic Stem Cell Support

Interventions

  • BiologicalImmune Ablation and Hematopoietic Stem Cell Support

    Autologous Hematopoietic Stem Cell Transplant

06

What researchers measure

Primary outcomes

  1. 11.1 CDAI - If the index worsens by 50 points for more than 4 weeks, the disease will be considered progressive; if it improves by 70 points for more than four weeks, it will be considered improved; otherwise it will be considered stable.

    Time frame: 5 years after transplant

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Study locations

1 site
  • Northwestern University, Feinberg School of Medicine
    Chicago, Illinois 60611, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00278577
Lead sponsor
Richard Burt, MD
Responsible party
Richard Burt, MD (MD, Northwestern University) — Sponsor-investigator
First posted
Jan 18, 2006
Start date
Apr 2001
Primary completion
Feb 2012
Completion
Feb 2012
Last update
Feb 6, 2014

Study contacts

Robert Craig, MD
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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