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An introduction to the Crohn’s Allogeneic Transplant Study (abbreviated CATS)

In patients who have Crohn’s Disease, inflammation in the intestinal tract can usually be controlled by medicine.  However, in patients with more severe Crohn’s Disease, the response to medicines can be short-lived, requiring higher doses, different medicines, and surgery to control symptoms.  New medicines have been introduced to care for patients with more severe disease that keeps returning.  These medicines treat Crohn’s Disease by weakening the immune system. A recent study showed that the best available treatment for moderate-to-severe Crohn’s Disease resulted in good control of inflammation in only half of patients at one year.  Some severe infections have been seen in patients with weakened immune systems.

In the Crohn’s Allogeneic Transplant Study, we will give a new immune system to patients who have active and severe Crohn’s Disease despite the best medical therapy.  This idea, of giving a new immune system to patients whose disease is caused by their own abnormal immune systems, is based on these observations:

  1. The immune system in patients with severe Crohn’s Disease is abnormal.
  2. Abnormal immune response to intestinal bacteria is rooted in genetic abnormalities.
  3. High doses of chemotherapy, like those given for patients with cancer, can calm down inflammation in patients with Crohn’s Disease, but in most patients, the inflammation returns. In these studies, a person’s immune cells are collected, then given back after chemotherapy has cleaned out the immune system. This process is called autologous transplantation.
  4. Transplant centers have reported that doing allogeneic transplantation has made Crohn’s Disease disappear for as long as 15 years, in a small number of patients. In allogeneic transplantation, someone else’s immune cells are given, providing a new immune system. These patients underwent transplantation because they had leukemia, in addition to their Crohn’s Disease.  They were cured of both leukemia and Crohn’s Disease.
    1. Lopez-Cubero S., et al. Course of Crohn’s Disease after allogeneic marrow transplantation (1998)
    2. Ditschkowski M., et al. Improvement of inflammatory bowel disease after allogeneic stem-cell transplantation (2003)

Who would be eligible for this study?  We will select patients with severe Crohn’s Disease and active inflammation despite the best medical and surgical treatments.  These patients must be healthy enough to undergo a transplantation procedure.  They cannot have an active infection, and their heart, lungs, kidneys, and liver cannot be failing.  We will review your answers to our questionnaire to start the screening process.

What would be required of me?  To be further considered for this study, you must come to Seattle to consult with the study investigators.  If you are found to be eligible and willing to proceed, we will contact your medical insurance company for approval of coverage for the transplant procedure, which will take place in Seattle.  Once we have this approval, we will begin a search for a matched donor, someone who will donate bone marrow cells for the transplant. You can anticipate spending approximately 3 – 4 months in Seattle to undergo the transplant procedure.

How is allogeneic transplantation done?  The process starts with chemotherapy and a small dose of radiation, to weaken a patient’s immune system so that it will accept immune cells from another person.  After that other person’s bone marrow cells are given to the patient, immune suppressive medicines are given to prevent the new cells from being rejected and to stop those cells from damaging the patient.  After the new donor cells start to work, blood counts will rise and the new immune system will start to grow.  During this time, there is a risk of infection.  Antibiotics and anti-viral drugs will be given to prevent infection.  When the new donor cells are well-established, immune suppressive medicines are discontinued. 

What are the risks and possible benefits?  Allogeneic transplantation carries risk, including death, because of infection, the rejection of donor cells, and those cells attacking a patient’s tissues (called graft-versus-host disease).  Our doctors are highly experienced in preventing and treating these complications.  The possible benefit is the disappearance of Crohn’s Disease.  In this study, we will examine parts of the intestine that were inflamed at baseline, to be sure the Crohn’s Disease has disappeared.   Patients will be formally evaluated for Crohn’s activity at 100 days after transplant, and yearly after that for 5 years.

Are you eligible? »
We are not accepting new questionnaires at this time. 

Physician Information »
A detailed summary for doctors, including links to the clinicaltrials.gov website and medical literature.

Contact Us »
At this time, we are not accepting inquiries about the CATS protocol.

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Updates »
The latest information about the Crohn's Allogeneic Transplant Study.