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Crohn's Disease Forum » Books, Multimedia, Research & News » New Clinical Trial Seeks to Cure Advanced Crohn’s Disease by Replacing a Diseased Imm


07-23-2012, 03:05 PM   #1
Igor_Passau
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New Clinical Trial Seeks to Cure Advanced Crohn’s Disease by Replacing a Diseased Imm

New Clinical Trial Seeks to Cure Advanced Crohn’s Disease by Replacing a Diseased Immune System with a Healthy One

Study represents new use of bone marrow transplantation
Newswise — SEATTLE – Researchers at Fred Hutchinson Cancer Research Center have opened a clinical trial to test the theory that giving a patient a new immune system can cure severe cases of Crohn’s disease, a chronic inflammatory condition of the gastrointestinal tract.
Funded by an infrastructure grant from The Eli and Edythe Broad Foundation, the initial goal of the Crohn’s Allogeneic Transplant Study (CATS) is to treat a small number of patients with treatment-resistant Crohn’s disease by transplanting matched bone marrow cells from a sibling or unrelated donor. Such a bone marrow transplant replaces a diseased or abnormal immune system with a healthy one.
The idea of swapping out the immune system is based on evidence that Crohn’s is related to an abnormal immune response to intestinal bacteria and a loss of immune tolerance. There is strong evidence that genetic abnormalities in the immune regulatory system are linked to the disease, according to CATS principal investigator George McDonald, M.D., a transplant researcher and gastroenterologist in the Hutchinson Center’s Clinical Research Division.
Although the CATS clinical trial represents a new direction for bone marrow transplantation, the procedure has precedent. The Hutchinson Center, which pioneered bone marrow and hematopoietic cell transplantation to treat blood cancers, has used allogeneic transplants to cure patients who suffered from both leukemia and Crohn’s, with subsequent disappearance of the signs and symptoms of Crohn’s. Similar experiences have been reported from studies done in Germany.
While autologous stem cell transplants – in which the patient’s own hematopoietic cells are removed and then returned after high-dose chemotherapy is given to suppress the immune system – have been used to treat Crohn’s patients, the benefits have not always been permanent, probably because the risk genes for Crohn’s are still present. “Autologous transplantation following chemotherapy beats the disease down but the Crohn’s tends to come back,” McDonald said.
More information about CATS can be found on the website www.cats-fhcrc.org, which includes a patient-eligibility questionnaire. In general, patients must be 18 to 60 years of age and have failed all existing conventional treatments but be healthy enough to undergo a bone marrow transplant. A matched donor of bone marrow must be found from either a sibling or an unrelated person who has volunteered to donate marrow. Private insurance must cover the cost of the transplant and related medical expenses.
Crohn’s disease is usually discovered in adolescents and young adults but can occur from early childhood to older age. The incidence of Crohn’s disease varies in different parts of the world with rates of four to nine persons per 100,000 people in North America. According to the Crohn’s and Colitis Foundation of America, a leading advocacy organization, Crohn’s may affect more than 700,000 Americans. Of those affected by Crohn’s, about 10 percent suffer from the most severe form for which no treatment is completely effective.
Symptoms of Crohn’s may include pain, fever, diarrhea and weight loss. Substantial progress has been made in medical treatment of Crohn’s disease over the last 15 years. However, even with the best immunosuppressive therapy, less than half of patients with moderate to severe Crohn’s achieve long-term relief. When patients stop taking their medicines, their intestinal inflammation returns. Some severe infections have been seen in patients who took prolonged courses of medicines that suppress the immune system.
“The burden of this disease lays heavily on those who don’t respond to any therapy,” McDonald said.
The CATS investigator team includes transplant physicians, gastroenterologists, pathologists and nurses from the Hutchinson Center, University of Washington, Seattle Children’s and the Benaroya Research Institute. The bone marrow transplant procedures will be conducted at the Seattle Cancer Care Alliance, the University of Washington Medical Center, and Seattle Children’s Hospital.
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At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers, including three Nobel laureates, bring a relentless pursuit and passion for health, knowledge and hope to their work and to the world. For more information, please visit fhcrc.org.
http://www.newswise.com/articles/vie...Latest+News%29
07-23-2012, 03:06 PM   #2
Igor_Passau
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very interesting!
07-23-2012, 03:23 PM   #3
Igor_Passau
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http://fhcrc.org/en/news/releases/20...s-disease.html

http://studies.fhcrc.org/cats/
07-25-2012, 01:25 PM   #4
Mark in Seattle
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According to my doc, this is for the most desperate of patients. I'm told that this treatment can kill you. Graft vs. Host disease was one example given for how it can kill you. I didn't inquire too much about it, he just mentioned it with the list of treatment options.
07-25-2012, 04:12 PM   #5
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According to my doc, this is for the most desperate of patients. I'm told that this treatment can kill you. Graft vs. Host disease was one example given for how it can kill you. I didn't inquire too much about it, he just mentioned it with the list of treatment options.
There have been around 20 of these procedures done for allo and around 40 for autogulous, in regards to treating crohns. Do you know how many have died so far? Not trying to pick on your doctor...but the answer is 0. Only patients that have died were the ones that got there too late, unfortunately. In the past, death was a very real thing to worry about. Since, they have refined the procedure though various ways ( like choosing more tolerable chemo drugs, not as toxic, and pre medicating for reactions now, and next will most likely be donor lymphacite infusions around week 3 to dramatically increase chance of the donor taking in my opinion. If you are having this done you should run that last thought by dr Burt, or by these guys and see what they say)

None the less everyone will handle this different. Some people hard a real hard time...but the transplant itself in its history for crohns has yet to endanger someone's life

I'm watching to see how they make the donors take. So far there has been a little trouble keeping it an allo transplant. The persons own immune cells take over. But 11 patients got it done right 15 years ago. Stayed well for 15 year so far i believe. I wanna see that done again... Hopefully they will crack this sooner than later

Last edited by Guest9283; 07-25-2012 at 04:57 PM.
07-25-2012, 04:15 PM   #6
Guest9283
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As always - thanks for the studies Igor! Don't stop...I read all of them you post.
07-25-2012, 07:25 PM   #7
Mark in Seattle
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I don't think my doc's comments were out of line in any way whatsoever. I think his statement that this treatment is only for the most desperate of patients meshes with Fred Hutchinson's requirement that the patient must have failed all other conventional treatment options to be considered for this study.

I also note the risk of death that Fred Hutchinson's web site states, which is exactly what my dr. said:


http://studies.fhcrc.org/cats/patient-info.html


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.
07-25-2012, 08:09 PM   #8
Guest9283
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I don't think my doc's comments were out of line in any way whatsoever. I think his statement that this treatment is only for the most desperate of patients meshes with Fred Hutchinson's requirement that the patient must have failed all other conventional treatment options to be considered for this study.

I also note the risk of death that Fred Hutchinson's web site states, which is exactly what my dr. said:


http://studies.fhcrc.org/cats/patient-info.html


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.
Yes mark. For liability reasons that has to be stated about death. If they did not, and you happen to be in the 1% that could possibly get an infection in your line and somehow not get treated for 48 hours and die...then your family could sue them. All I'm trying to say is I wish doctors would open up to the idea that these transplants can be performed in a controlled manner. Instead of having you feel like you only have a 50% chance of making it out of a transplant alive. This is why I don't comment much...everyone's so defensive. Im by no means stating its easy. But it's not playing Russian roulette either

No candidates are picked if the doctor doesnt feel they are fit to get through the transplant. It's not as easy as putting your name on a sign up sheet... A lot of pre testing. A lot of pre medicating. Meds for rejection, meds to prevent gvhd = evolving process, and lowered risks.

Last edited by Guest9283; 07-25-2012 at 08:37 PM.
07-26-2012, 01:22 PM   #9
Max's Mom
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Thanks,Mr Ziggy. When I hear that there might be a cure one day for this horrible disease,I feel like I want to scream out loud and jump for joy.I cannot bear the thought that my boy will have to live with this for the rest of his life. I am shocked that not more people are all over this.I do not have Crohn's, but if it helped my guy in any way I would go through that treatment,or any treatment, so that he can have a normal,painfree life.I want to thank you guys who have gone through the stem cell treatment and who are thinking about doing it.Cecilia.
07-26-2012, 02:04 PM   #10
MADiMarc
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Thank you for your post. I found it very informative. I also found back up documentation to support this information at the library.
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07-27-2012, 01:35 PM   #11
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Thanks!

Last edited by Tenacity; 07-27-2012 at 03:22 PM.
08-02-2012, 01:17 PM   #12
Guest9283
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Thanks,Mr Ziggy. When I hear that there might be a cure one day for this horrible disease,I feel like I want to scream out loud and jump for joy.I cannot bear the thought that my boy will have to live with this for the rest of his life. I am shocked that not more people are all over this.I do not have Crohn's, but if it helped my guy in any way I would go through that treatment,or any treatment, so that he can have a normal,painfree life.I want to thank you guys who have gone through the stem cell treatment and who are thinking about doing it.Cecilia.
Cecilia, thanks for keeping in touch. I too still get excited every time I hear that Burt accepted more patients. It means that he still believes with 100% conviction that the answer lies here, and that he is on the right track. He wouldn't accept another patient if he ever doubted otherwise. My quality of life right now is at 100%. Been setting some goals I never thought I'd be able to reach again in life. Truly blessed. I can eat anything I want nowadays, but I still stay on track because I know the reality of the autogulous transplant. I think be it through stem cells or via others source, this crohns has its days numbered. Doctors in every field seem more hopeful when talking about it too nowadays. I see some people doing the Osiris trial. I just hope expectations are not too high. You need the chemo. Day one after chemo it solidifies to everyone that crohns is an auto immune disease which can be successfully regulated with brining down the immune system.

Last edited by Guest9283; 08-02-2012 at 01:46 PM.
08-05-2012, 11:53 AM   #13
Max's Mom
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I'm just wondering how long it will be before everyone gets treated.I want us to be at the top of the list at that point.I am so tired of sitting around waiting for my son's intestines to get damaged little by little and eventually needing surgery.But then again,will they treat kids?
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