Seeking Stem Cell Overview

[Mark in Seattle]

Hello,

My GI has suggested I try a biologic, such as Remicade or Humira. I've never tried a biologic, but due to side effects and/or possible lymphoma risk, not to mention the cost and long-term commitment, I'm more than hesitant to embark down that path.

I've been reading a bit on this site recently about some folks who are trying stem cell therapy for the Crohn's.

I'm wondering if anyone can point me to a link or blog or web site, or perhaps just type out some information for me regarind the stem cell therapy.

What I'm wondering is as follows:

1) Is SCT approved for Crohn's in the USA currently or is it only for trials?

2) As far as USA trials, is Osiris Pharma the only trial underway?

3) Osiris told me I had to have failed biologics in order to be admitted to their trial. Are there any other trials or ways to get approved for SCT without trying biologics first?

4) Does SCT have any real studies/statistics to indicate how effective it is for Crohn's?

5) Assuming I could find a way to get SCT, I wonder what the odds of my insurance paying for it would be. Do insurance co's usually require biologic attempts first?

6) When we say "Stem Cell Therapy", I believe there are separate types/methods/categories of therapy. Or am I wrong - is it basically just one method being use for Crohn's patients?

Thanks!!

 

[effdee]

If you look at the sticky'd threads in the treatment section, Mr. Ziggy blogged his experience with a stem cell transplant.

A video blog about another patient - http://www.robertsroadtofreedom.com/

I'll be starting my stem cell transplant tomorrow, and I'm blogging the experience as well. - http://www.mypsct.blogspot.com

1) Stem cell transplants are still trials in the U.S., and Europe as well. I've been told it's an approved alternative treatment in Spain.

2) There are trials at Northwestern, Duke, and somewhere in Atlanta. There may be others, but those are the what I'm aware of in the country. I would be surprised if more aren't starting in other places soon based on how successful it has been.

3) I believe the eligibility criteria are similar for all of the trials. You must have tried and failed most typical treatments, meaning 5ASA, steroids, azathioprine/5mp, at least one anti-TNF alpha inhibitor. You can find more of the criteria for Northwestern's trial here: http://clinicaltrials.gov/ct2/show/NCT00271947?term=northwestern+stem+cell+transplant&rank=11

4) SCT's are still new so there isn't a ton of data, and less long term data. Here's the latest I've been told about Northwestern's trial.

For cord blood allogeneic, we have just done one patient for Crohn's- the patient
has been in remission for the last 2 years (since 2009) with no symptoms. Our
fellow, Dr. Jain wrote a paper on it and it is awaiting publication, so
unfortunately I can't share it or discuss the results yet.

For autologous, we have done 27 patients on and 5 off study. See abstract statistics for our Crohn's auto study below-

Eighteen of 24 patients are 5 or more years after transplantation. All patients went into remission with a CDAI less than 150. The percentage of clinical relapse-free survival defined as the percent free of restarting CD medical therapy after transplantation is 91% at 1 year, 63% at 2 years, 57% at 3 years, 39% at 4 years, and 19% at 5 years. The percentage of patients in remission (CDAI < 150), steroid-free, or medication-free at any posttransplantation evaluation interval more than 5 years after transplantation has remained at or greater than 70%, 80%, and 60%, respectively.

The new direction they're heading is with allogeneic transplants. They think that will further decrease the chances of relapse. Even for those who relapse, the disease is milder and more responsive to treatments, including those that stopped working for the patient prior to the transplant. Stem cell transplants preformed for other autoimmune diseases have been very successful, as well.

5) It varies from company to company. Some will pay for it without batting an eye, some will take months and require appeals, and some won't cover it. I don't think the insurance companies are concerned about having tried a biologic first, but I don't think people have been in that position. You usually don't get accepted to the trial without having been on one.

6) There are different treatments involving stem cells for Crohn's. I know they have done stem cell infusions alone and it has been effective. The "stem cell transplant" usually refers to the protocol involving chemo to destroy the Crohn's-ridden immune system and then the stem cell infusion.

Let me know if you're interested in more info. I can find some of the published papers about the transplants.

 

[Mark in Seattle]

Thanks a bunch effdee. This should help me have a starting point to understand sort of where things are at. You mention cord blood. I know that when babies are born, the parents have the option of storing cord blood cryogenically. Is the cord blood method that you mention only applicable to people whose parents have had the cord blood stored cryogenically or does it mean that they take cord blood from some other donor?

 

[effdee]

No problem. The cord would almost certainly come from a donor. Storing the cord when a child is born is a relatively recent option, so few patients old enough for the stem cell transplant would have their own banked. Another piece is that they only store healthy cords. Anyone with a history of any illness won't have the cord put in the donor registry. That also serves an extra benefit for the recipient. The stem cells from the cord blood, in allogeneic transplants, will mix with the patient's immune system to a degree. That lessens the likelihood of relapse compared to an autologous transplant, where the properties of the patient's immune system would remain the same as before. Cord blood stem cells are also younger and more naive (fewer influences, meaning fewer negative influences) compared to adult donor stem cells.

 

[Guest9283]

Nice but as i know In November of 1998, scientists reported that they had successfully isolated and cultured human embryonic stem cells—a feat which had eluded researchers for almost two decades. This announcement kicked off an intense and unrelenting debate between those who approve of embryonic stem cell research and those who are opposed to it. Some of the most prominent advocates of the research are scientists and patients who believe that embryonic stem cell research will lead to the development of treatments and cures for some of humanity’s most pernicious afflictions (such as Alzheimer’s disease, Parkinson’s disease, heart disease, and diabetes). Among the most vocal opponents of the research are those who share the desire to heal, but who object to the pursuit of healing via unethical means. CBHD’s view is that because human embryonic stem cell research necessitates the destruction of human embryos, such research is unethical—regardless of its alleged benefits. Ethical alternatives for achieving those benefits should be actively pursued.

Thus comforting knowing that the cord blood from Burt has no un-ethical issues as no lives are taken. He touched on embryo stem cells and they could be sourced without the taking of anothers life too, through the donor bank. You can see this lecture and many more older ones at Burts website. It seems to be down temporarily, but im sure you can find the videos on the web.

Intersting 1st post. Also noticed your stem cell patented product that you are pushing in your signiture. There is NO need for menstal blood cells in our transplants, so please don't come here messing what im trying to do here, helping sick people. The last thing i need is some sales rep coming here and confusing people on a subject that is already hard enough to grasp. Especially not for your financial bennifit. - I'm here for non profit. You're not.

 

[Guest9283]

Thanks a bunch effdee. This should help me have a starting point to understand sort of where things are at. You mention cord blood. I know that when babies are born, the parents have the option of storing cord blood cryogenically. Is the cord blood method that you mention only applicable to people whose parents have had the cord blood stored cryogenically or does it mean that they take cord blood from some other donor?

Mark the cord blood is from a highly reputable bank in NY. They go through extensive testing, to match you, and to make sure the cells are safe and clean. They then send them to burt, which then given to you, upon completion of chemo. I hope you look more into it Mark. From experiance I can tell you, that you're not wasting your time. Good luck!

 

[David]

FYI: I've deleted the post by cellecell and banned him as he was a spammer. But I'll leave Ziggy's post and quote as it has become part of the thread. Thanks

 

[Slim Johnson]

At David's suggestion, I am reading these SCT threads.

It really frustrates me that here we have something that could potentially CURE our affliction, yet big Pharm is not getting behind it. Then there is the ethical rhetoric.. WTF!!!

I have always felt that the Pharm companies are out to keep us sick. Case in point, the unnamed company that owns the gene responsible for breast cancer. You have to pay exorbitant fees just to research the gene... IMO keeping breakthroughs from really occurring.

My opinion is that once we take the profit out of illness, we will start to see cures.

 

[KTA]

Hi Mark! I posted this on another thread, but I recently read in the Crohns Foundation newsletter that they are starting up another Phase III trial using PROCHYMAL®. I'm not sure where the trial is being conducted, but it has to do with using stem cells from healthy adult donors and infusing them into the patient. You may be able to look it up on the web. From what I remember in the article, they infused the cells every two weeks for a month. Some patients would have remission for 6 weeks, others would have remission for 6 months. I'm sure the cells are tested like blood to protect against HIV and all those other terrible diseases. But....it's another new therapy that may bring us all a lot of hope and is completely different from the TNF inhibitors that so many can not tolerate.

 

[scotishcanadian]

I'm currently part of a human placenta derived stem cell trial through a company called Celgene. It's done through i.v. infusions of the stem cells, no chemotherapy required. So far my symptoms have been slowly decreasing. So far, so good. :]

 

[KTA]

I'm so happy to finally hear that they are using stem cells to help people with this disease. I wish everyone a lot of luck with the less invasive treatments. And I agree Slim.....I sometimes think these pharmacuetical companies are running the country. Such a big business!

 

[Crohnmum]

hi all,
I'm currently pregnant with my second child. My first- 7 yo beautiful girl was diagnosed with very aggressive Crohn's early this year. She has had an ileostomy and is doing well. We are currently on the surgical list for her reconnection (fingers crossed all goes well).
Now I have a choice to keep the cord blood from this delivery. It is quite expensive but do you think it would be worth it? Perhaps in the future for my 7yo or if my other child were to be diagnosed with crohn's?
ANy thoughts would be really appreciated.

 

[KTA]

Hi Crohnmum:

I work in a research facility and my boss said that it might be a very good idea. He said you can get some good stem cells from cord blood. There are other ways to get stem cells but cord blood is a good option.

 

[Crohnmum]

Thanks KTA. Now I have to go shopping for cord banks!! Money money money!!

 

[soretum]

Hi Mark in Seattle,

I'm on the phase III of the Osiris study at the moment. Finished my infusions a couple of months ago, first 4 infusions were given over 2 weeks and were either high dose stem cells, low dose stem cells or placebo. The last 3 infusions were given at 6 week intervals and were low dose stem cells. I had to meet certain criteria to get onto the study which included failing steroids, immunosuppressants and a biologic.

I've had mixed results, managed to finally get off the prednisone (which wasn't really working anyway and giviing me awful side effects) and got my CRP down to 29from 80....was feeling reasonably good until the last infusion, I was expecting to feel grotty for a few days after the infusion as was the pattern with the previous ones but for some reason I just didn't come right after that one and CRP has gone back up to 63 over the last couple of months. Was definitly feeling my best in the weeks before that last infusion and was really hopeful we were getting on top of it so it's been a little dissapointing that things have gone backwards.

My medical team and I have been flying somewhat blind as Osiris dont really offer too up much information, I have been the first in New Zealand to recieve the treatment so no one else to compare my results to, none of us really knew what to expect from it.
Have had to make the decision in the last couple of week as to what to do next, wait for a bit longer and hope the stem cells continue to do their thing or to start remicade (i've already failed Humira). Have decided to start remicade, makes me uneasy that my CRP is creeping up again and that I really dont feel that great so not willing to take the risk and have things spiral out of control again, not much between me and a total colectomy now:facepalm:

SO anyway, mixed results and not quite the miracle I'd hoped for but dont regret doing it at all, who knows they may still be working their magic in there....

 

[Rishi]

Hi Crohnmum:

I work in a research facility and my boss said that it might be a very good idea. He said you can get some good stem cells from cord blood. There are other ways to get stem cells but cord blood is a good option.

Is there a cheaper option for stem cells than cord blood?

 

[AlexVBack]

hi all,
I'm currently pregnant with my second child. My first- 7 yo beautiful girl was diagnosed with very aggressive Crohn's early this year. She has had an ileostomy and is doing well. We are currently on the surgical list for her reconnection (fingers crossed all goes well).
Now I have a choice to keep the cord blood from this delivery. It is quite expensive but do you think it would be worth it? Perhaps in the future for my 7yo or if my other child were to be diagnosed with crohn's?
ANy thoughts would be really appreciated.

Crohnmum – Cord blood storage is becoming a really popular way to have access to stem cells, but fetal pluripotent stem cells may be more effective in targeting a given ailment. I’ve seen a lot of research done by the clinic Stem Cell of America – who sticks exclusively to fetal stem cells. Check them out. This way also doesn’t require you to store the cord blood at birth, since these pluripotent cells are compatible with anyone.