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
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.
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 →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.
Exclusion Criteria
Biological: Immune Ablation and Hematopoietic Stem Cell Support
Autologous Hematopoietic Stem Cell Transplant
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
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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Richard Burt, MD