Stem cell/kidney transplant clinical trial seeking participants

[cariad]

I want to put this out there, in this section because it has a wider audience and this is really only relevant to people on dialysis or pre-dialysis who are seeking a transplant.

Northwestern is actively seeking participants for the clinical trial that I underwent. It is a combination kidney and peripheral blood stem cell transplant with a view toward getting you off all immunosuppresants within a year. I went through it a year ago and I can say several quick things about it: there was a lot of pain (for me) immediately before and after the transplant. I am devilishly sensitive to everything, though - so I vomited a lot after surgery (yeowch!) and my recovery took weeks longer than average. It has been a year (tomorrow) and I feel great. When I come off the drugs completely (which will happen today if my biopsy is clear) I expect to feel even better. Most importantly, I have met hundreds of doctors in my life and this surgeon is the best. He has a personality, he is incredibly compassionate, and he works with a team that will make caring for you their top priority. Northwestern is a frustrating hospital to navigate, I will be perfectly honest about that, but being in a trial you are able to bypass a lot of that nonsense.

There are some important qualifications that you would need to meet: You must have a live donor. You must have private insurance or medicaid (if they will pay for what Medicare does not) or be able to pay the Medicare excess out of pocket. You do not need to live in Chicago (I don't) and they will put you up for free at a hotel for the week or so after transplant. Your support people will need to pay for a room there, but you get an incredible rate through the hospital ($99/night is what ours paid). The hotel has a kitchen, which was vital to us after transplant (could store all the drinks I could manage in the fridge). Certain diseases will disqualify you. You will need to return to Northwestern periodically for 3 years following transplant. You need to weigh within their BMI requirements, and I think you need to be EBV+, but I am not sure about that. [NEVER MIND!] I am sure there is more that could disqualify you, but those are the basics. They accept people between 18 and 65, I think. Not every participant has been able to come off the drugs completely, but you would be on minimal doses and steroid-free. If you are truly interested, feel free to PM me and I will happily give you contact names or tell you more about my experiences (you can read most of it on here, but it is spread out and probably a bit confusing to follow). Or we could talk by phone if you prefer. My experiences with this trial, pain and all, have been wonderful. Ah, and I just got a call from the surgeon checking on me with my biopsy complications. I really am so grateful for this trial and would be delighted to see another IHD member give it a go.

Thanks for reading. Do not hesitate to contact me if there is even a slight chance that you would consider this. I love talking about this trial and this amazing transplant team.

Link to an article about it. I am mentioned in a roundabout and anonymous way.... http://www.courier-journal.com/article/20110307/FEATURES03/303070003/University-Louisville-researcher-cusp-organ-transplant-breakthrough This article was described as "very accurate" by one of the research RNs.

[MooseMom]

Oh God, I wish.  If I had a live donor, I'd be there in a heartbeat.  But no one really cares if I live or die, so I'm no good to medical science.

I hope someone here can benefit from this.  I guess this really is the only "cure" for CKD.  How wonderful!

[cariad]

I care, my dear. So do many others here. I wish that could help you in your current situation. I totally get that in the end, our caring just isn't enough.

They are working on transferring this technique to cadaver organs. I will update if I discover that they are looking for those recipients at Northwestern. (they have started at Harvard, but that's a different protocol, and as I've said, I got a really bad feeling from the surgeon in charge of that one.  I call her The Wicked Witch of the East)

Bring on the lab-grown kidneys!

[jeannea]

I'm with you on the lab grown kidneys!  Or else the pig kidneys. What do I care.

I would do this if I could but I don't have a living donor either. I've had a previous transplant and would LOVE to be without those drugs next time.  I hope this works for you.

[greg10]

Thanks for sharing.  Very interesting.

[monrein]

I really hope that someone through this site can benefit from this opportunity.  The chance to be transplanted without a long-term immunosuppressive drug regimen would be amazing to me.  I'm always so glad when I hear how well its working out for you so far Cariad.

[MooseMom]

I have two quick questions.

Do you have any idea  at what point will the procedure that you had will become common practice?  What are the researchers waiting to happen before they recommend this protocol become the norm?

As for transferring this technique to cadaver organs, how could that work?  I mean, doesn't it take some measure of time to prepare the recipient's body?  How would one preserve a cadaveric kidney for that long?  Any idea?

[cariad]

Hey, MM, just popping in for a moment. Spent the day entertaining a Scotsman who wants to walk all over town (has been stuck in too many airplanes, cars and meetings previous to his visit) and so I have certainly received some much needed exercise. He flies back home tomorrow, so I sent him and Gwyn off to the local brewery so I can recuperate and then pick up the kids.

Anyhow, your questions. Afraid I cannot be much help because I just don't know. I do know, however, that there was a time not too long ago where desensitization was only for recipients with a living donor (around 2006 it was a novelty, now it's old news) and now it can be done for those receiving a cadaver. An acquaintance of ours was the first in the country (possibly the world) to be desensitized and receive a cadaver organ. I believe this was mid-2007, and it was a clinical trial in Madison. So, I imagine whatever they managed to do for her they also could do for cadaver organ recipients with this. Yes, it certainly does take a solid 5 days, but I imagine they will get to a point where they can start cutting that down. I mean, the first person ever to go through this type of procedure - a young woman who went to Mass General - she had to spend two weeks in isolation. I just had to wear a mask until my WBC came up to near normal, and I wasn't even that great about wearing the mask because it made me feel nauseated. I had a WBC as close to zero as you can get without wiping it out completely. I imagine that they will find that they do not have to be that aggressive as they send patients through these trials in the coming months and years. That is basically what has to happen before this can be used more routinely: they must go through the different phases. They completed phase 1, which is the small group of recipients. They are now in phase 2 which allows them to widen their scope, and when they get to phase 3 (if they do) they will be close to getting this approved as the standard. I once had an audience with Dr. Vincenti who developed Belatacept and he told me he expected it to be marketed by 2009. I have seen that Bristol-Meyers has taken it on, which must be great news for him, but I don't know that it is out of the experimental phase even today. It can take a lot longer than they originally predict, and there are so many issues that could crop up and prevent the drug from ever getting to market. I think 7-10 years is the shortest span possible. But they need participants to make it happen.

I don't want to give any false hope. This was quite an ordeal, there is a very real risk of blood cancers in my future (but then the immunosuppressives have cancer risks as well) and it was at least a month after the transplant before I could even walk very far or get through the day without sleeping through most of it. It was two weeks before I stopped dreading needing to get out of bed (getting in and out of bed was excruciating). The follow up has been intense. I have had to really gauge whether I think something is important enough to tell the hospital, because once I tell Northwestern, the answer is almost always "come down and see us", especially in the first three months. Your local hospital will no longer know how to deal with you. I am back on twice a week labs (I only had a month of the "luxury" of once a week labs) and for all I know next week I'll have a creatinine spike and that will put paid to getting off the drugs. These are risks I eagerly take on because the potential benefit is too great for me to resist. Not everyone will feel this way, though, and I cannot blame them for that.

I've posted this before, but here is a link to the trial on clinicaltrials.gov. I am nearly certain that you can ignore the part about excluding retransplants, and I have an email out to the research coordinator asking her to verify this. When I mentioned it to the surgeon way back when, he did say they would enroll retransplants. (I'm a retransplant in case anyone did not realise, and they let me in.) I have to say, this is not something you can want just a little bit. It will at times seem like it's all too much, but then, we all get plenty of that with every aspect of kidney failure. http://www.clinicaltrials.gov/ct2/show/NCT00497926?term=kidney+transplant+stem+cells&rank=9

OK, I feel like I'm lecturing now, so I'll stop.

Monrein, you are just so sweet. Thank you!

Thanks for your interest, everyone, and again, anyone is welcome to PM me if they want to hear personal experiences. I'm a little distracted at the moment, but come Sunday, life settles down again. I do love hearing from any of you. (Oh, and not to exclude the foreigners, if you happen to come from money they will happily enroll you in this trial if you qualify medically. You'll just need to pay for the transplant out of pocket, or convince your country to pick up the bill. No big deal, right? )

[cariad]

I received a reply from the research coordinator yesterday.

And I quote:

In regards to your question, I believe Dr. L. would look at each case individually. If the patient was evaluated and met transplant criteria, I do not think he would be opposed to enrolling another subject who was a re-transplant. We have actually modified our protocol so that we can include re-transplant subjects. However, that being said, there are many other factors that he would look at that may exclude a re-transplant patient from our trial (for example if they had a high PRA). I have forwarded this question to him to see if he has a more definitive answer, but I think it would be safe to say this determination would be made after clinically reviewing the patient.

So there it is.

Greg, I did not notice that you managed to post the graphic from the article. How cool - thanks! Not sure why they show a big syringe, as the stem cells are withdrawn via an untunneled line - more from the neck than the chest - and given to the recipient via an infusion. Giant syringes did not play much of a part in this, though there were plenty of needles.

Since there are a few people who mention a lack of live donor as a limiting factor, I will ask her if they have any plans to start this procedure using cadaver organs. I would like to know myself.

[Sunny]

I was not allowed in Stanford's stem cell program similar to yours due to my high PRA's (90%), so that may be a disqualifier even for a 1st time tansplant.

[kristina]

Thanks cariad for sharing with us Northwesterns new program.

I would like to know more about the evaluation process of participants, for example:

Would any of these or a combination disqualify a participant, i.e. having suffered a stroke,
suffering from chron proliferative glomerulonephritis, Lupus/SLE/MCTD & chronic hypertension?

Which are the diseases which disqualify participants from being accepted by Northwestern?

What does IBV+ stand for?

What is their success-rate? Do all participants have a good survival-record?

Thanks from Kristina.

[KICKSTART]

Shame some of us are in the wrong country !!!

[cariad]

Thanks for the info, Sunny. I am not sure why PRA would matter so long as the crossmatch with the donor was negative, but perhaps it has something to do with also needing to match stem cells?

When I was in lengthy discussions with Mass General about this, that was what tanked my relationship with them. My PRA went above zero, and not far above zero. The surgeon told me that of their 5 patients, the only one who was not able to come off the drugs (or maybe his kidney even rejected, I cannot remember) but the only unsuccessful attempt they had was with someone with a PRA of 6. Six!!! I am going to call coincidence on that one, but they would hear none of it in Boston.

Yeah, KS, many members are in the 'wrong' country, but there are trials using stem cells starting up in London. The nice thing about trials in London and elsewhere throughout the world is that they can make decisions based solely on health, not health and access to funds and insurance.

Kristina, without being a medical person, I can only guess, but I am nearly certain that Lupus or any other autoimmune disease would exclude you. In theory, one of the better treatments for autoimmune disease is immunosuppression, so they would not be able to withdraw you completely from immunosuppression. One of the people who entered this trial was not able to come off the drugs completely because he had signs of his original disease recurring. I did not ask, but I assume this is FSGS. I don't think this really means the trial is a failure, though. They are trying to push the envelope and include people who are not eligible for the other trials that are similar going on around the country. For those trials, you might need a sibling donor or a PRA of zero (I had neither) or it has to be your first transplant. All of these were obstacles for me until I found Northwestern.

Talking about Lupus, though, it's been all over the news here that they have approved the single greatest advancement in Lupus treatment in 50 years. Perhaps you could investigate this treatment? When Kickstart says wrong country, she is not kidding. We are notorious capitalists here. The surgeon works for the hospital and does not have any say in what they charge, so as compassionate as he is, there is nothing he can do for foreigners who lack the roughly $300,000 (~200,000 quid!) that a transplant costs. That is why the posting on clinicaltrials.gov explicitly states non-Americans need to bring their own funding. I am just reiterating this, as I imagine you are only asking out of curiosity and were not planning on trying to enroll in the study.

Success rate is far, far, FAR too early to tell. It would not be fair to them to speak in terms of percentages, as this trial only started in 2009, and then they had a number of issues with the FDA after the trial started that delayed them. They have been given the OK to move into phase II, so that shows that the government is satisfied with their procedure thus far. Patient survival rate is 100%to date, as would be expected. Graft survival rate is above 90%. Success in getting patients off the drugs completely - well, it takes a year, so we need to give them some time. It's looking like it will be at least 75%, but probably higher as they move forward. They are learning as they go, and learning quickly.

I was wrong about the EBV+ requirement - I was thinking of Harvard's trial. EBV is just Epstein-Barr, if you've ever had mono or been exposed to someone with mono, you probably are positive for it, and you may not have even realised that your system fought it off. I'll go cross that part out, now.

Thanks for the comments, everyone.

[kristina]

Thanks cariad for the information.
I can well understand that suffering from an autoimmune disease
like SLE/Lupus/MCTD might preclude one from such a trial,
as would, I suspect, a patient like myself who has suffered a stroke,
because I was told by a medical person that under anaesthetic
strokes are a further risk of suffering another stroke.

I was not only asking out of curiosity.
I like to know up-to-date-information on how medicine is advancing
in connection with the treatment of autoimmune disease like SLE/MCTD
in combination with both kidney-transplant and the regeneration of one’s own kidneys.
I know that it takes some years for treatments to come on line for the general public,
and I find it interesting to follow these developments just in the vain hope
that there might be something, one day, to help me medically in my predicament.

With regard to a new treatment for Lupus/SLE there are always side-effects
and I am not sure if my delicate health at the moment (10-12% kidney function, no Dialysis)
could withstand the effect of symptoms arising from medication,
as I suffer very severely from multiple drug-intolerance.
I have known patients who suffer from Lupus
and they have taken the common treatment cortico-steroids,
but they and the doctors don't talk honestly about the bad side-effects
which the cortico-steroids caused them over the years.

It would be wonderful for kidney-transplant-patients
to be able to come off all the many drugs/medications
which they have to take, as long as it leaves them able to continue their life.

I do wish you all the best for your stem cell/kidney transplant clinical trial
and I do hope you have many years without any medical bother.

Best wishes and thanks for the information from Kristina.

[gaelicdevil]

It's not a pretty scar. I have it elbow to armpit. Superglued back together. The new thing. I was not allowed to use the arm for about a week. It works now but it's ugly. Surgery was last October, being HDing since January.

[cariad]

I received a reply back on my question about using cadaver organs in this trial. The coordinator said that it has been discussed, but that it would probably be several more years before it happened at Norhtwestern. At least they are talking about how to make it work, though.

She also said their BMI max for donors is 35. I think BMI is a stupid measure, and would argue with anyone who tried to tell me that a little extra adipose tissue is going to do any real damage. They do not have the journal articles to back their claims, so I would think most surgeons would be open to discuss it. I once read a doctor's account of why surgeons detest fat and don't want to work on heavy people: extra fat makes it difficult to see, and in the old days, surgeons would have to hold open the abdomen with paddles, and this is exhausting work after a short time. The more fat on the patient, the more quickly they tire. The medical world has certainly done an amazing PR job on all of us, making us all think we'll drop dead if we weigh a little outside their rigid window. (And some of us will drop dead if surgeons can continue to get away with weight bias.) I see people spouting the myths about weight all the time. It makes me crazy, especially since weight obsession robbed me of much of my childhood.

Anyhow, Gwyn has a BMI around 26, and he still thinks he's fat. When I told him he'd have to weigh 164 to be in the "healthy" range he laughed and said he believed he was 14 the last time he weighed that. If he had had a BMI over 35, we would have had that argument with Northwestern, too. If it is not based in medical science, then you cannot justify it as far as I'm concerned. Overweight people are so conditioned to blame themselves for their weight that few of them stand up for themselves when it matters. I know for a fact that weight has very little to do with how much one eats, and loads to do with one's genetics, and occasionally other factors like medications.