Immune Ablation and Stem Cell Support for Crohn's Disease

NCT00179842 | Withdrawn Phase 2

• 1 other identifier: BMT 1202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators anticipate that this study will also form the basis to clarify further the role of the immune system in Crohn's disease.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• To investigate the safety and efficacy of treating severe CD with high dose cyclophosphamide and antithymocyte globulin rescued with T cell depleted autologous stem cells. Data will be used to evaluate the efficiency of a future phase III protocol.

  Minimum of 2 years

Interventions

Stem Cell Transplant PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Less than physiologic age 60 at time of pretransplant evaluation.
• An established clinical diagnosis of severe CD that has failed therapy with prednisone, azathioprine, 5 ASA products and metronidazole, and has failed to have a sustained decrement of 70 points in the CDAI after one course of anti-TNF alpha, Infliximad. The patient is being considered for therapy with cyclosporin A (CSA) or surgical resection. The CDAI (appendix A) is 250-400.
• Pre-study peripheral blood counts must include a platelet count greater than 100,000/ul and an absolute neutrophil count greater than 1500/ul.
• Stem cell harvest greater than 1.4 x 106 CD34 cells/kg after CD34+ selection (to continue to transplant.)

You may not qualify if:

• HIV positive
• History of coronary artery disease, or congestive heart failure.
• 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
• 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.
• 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.
• Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
• FEV I/FVC \< 50% of predicted, DLCO \< 50% of predicted.
• Resting LVEF \< 40%
• Bilirubin \> 2.0 mg/dl, transferase (AST) \> 2x upper limit of normal, unless the abnormalities are secondary to Crohn's disease.
• Serum creatinine \> 2.0 mg/dl.
• Platelet count less than 100,000/ul, ANC less than 1500/ul.
• 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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Sonali Chaudry, M.D.

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 16, 2005
• Study Start: March 22, 2007
• Primary Completion: December 19, 2008
• Study Completion: December 19, 2008
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

US (1)