Prochymal Stem cells

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redspot321
Regular Member


Date Joined Jan 2006
Total Posts : 303
   Posted 3/4/2009 7:59 PM (GMT -7)   
 
 
Whats the latest news on this treatment? I used to hear alot about it. Is it working?
30yo male
Currently on LDN for Crohn's with good results
 
63cm resection in '08, exausted all meds except pred :)
Avascular necrosis of both hips, Degenerative Disk disease with 5 herniated disk, Asthma, etc etc....


pb4
Elite Member


Date Joined Feb 2004
Total Posts : 20576
   Posted 3/4/2009 8:12 PM (GMT -7)   
This is the latest I've heard on stem cell research...

Researchers find safer way to make stem cells
Ben Hirschler, Reuters
Published: Monday, March 02, 2009
LONDON (Reuters) - Researchers said on Sunday they had found a safer way to transform ordinary skin cells into powerful stem cells in a move that could eventually remove the need to use human embryos.


It is the first time that scientists have turned skin cells into induced pluripotent stem cells or iPS cells -- which look and act like embryonic stem cells -- without having to use viruses in the process.


Ampoules containing a medium for stem cell storage are displayed at the UK Stem Cell Bank in London, England. Researchers say they have found a safer way to transform ordinary skin cells into powerful stem cells.
Peter Macdiarmid


The new method also allows for genes that are inserted to trigger cell reprogramming to be removed afterwards.


Stem cells are the body's master cells, producing all the body's tissues and organs.


Embryonic stem cells are the most powerful kind, as they have the potential to give rise to any tissue type. However, many people object to their use, making iPS cells an attractive alternative, provided they can be made safely.


Researchers have known for some time that ordinary skin cells can be transformed into iPS cells using a handful of genes.


But to get these genes into the cells they have had to use viruses, which integrate their own genetic material into the cells they infect. This can cause cancer.


The alternative approach, described in the online edition of the journal Nature by two teams of researchers from Britain and Canada, appears to avoid the risk of such abnormalities.


"PIGGYBAC" RIDE


The researchers harnessed a little piece of DNA called a transposon -- sometimes known as a "jumping gene" because of its ability to move around inside the genetic code -- to carry four genes.


The version used is dubbed "piggyBac" and has been used by researchers to genetically modify a range of organisms.


"It is a step toward the practical use of reprogrammed cells in medicine, perhaps even eliminating the need for human embryos as a source of stem cells," said Keisuke Kaji from the Medical Research Council (MRC) Center for Regenerative Medicine in Edinburgh.


He and Andras Nagy from the University of Toronto used the technique in both mouse and human skin cells and found the reprogrammed cells behaved just like embryonic stem cells.


Ian Wilmut, head of the MRC center and one of the scientists who cloned the first mammal, Dolly the sheep, said it would take time before the new iPS cells could be given to patients, but the new technique was an important step forward.


"Combining this work with that of other scientists working on stem cell differentiation, there is hope that the promise of regenerative medicine could soon be met," he said.


Doctors hope one day to use stem cells to treat diseases such as Parkinson's, diabetes, cancer and spinal cord injuries.

:)
My bum is broken....there's a big crack down the middle of it! LOL :)


onebloodonelife
Veteran Member


Date Joined Feb 2006
Total Posts : 842
   Posted 3/6/2009 5:13 PM (GMT -7)   
Trials are still plugging along. I'm currently trying to get into the one at the University of Minnesota, after failing Remicade, Humira, and now Tysabri.

My GI did say that there will be an open-label portion coming up soon, so if you've received Prochymal during the trials, it would be made available to you without the risk of getting a placebo.

Also, I believe, as long as the trials go well (and they've been great so far), Prochymal's looking to be FDA approved this year or next.
Crohn's Disease for two years and counting (diagnosed March 8th, 2006)
Failed medications: Prednisone, Imuran, Remicade, Humira
Starting Tysabri the week of 9/22/08


Rider Fan
Veteran Member


Date Joined May 2008
Total Posts : 1445
   Posted 3/6/2009 5:39 PM (GMT -7)   
How can you tell how the trials are going? Do they release some results before the study is published?
32 y/o male. Dx'ed in 1999. No surgeries.

Current meds: Humira. 25mg prednisone. Udo's Choice Probiotics (30 billion).

Tried SCD, didn't work, now avoiding gluten and dairy.


onebloodonelife
Veteran Member


Date Joined Feb 2006
Total Posts : 842
   Posted 3/6/2009 7:48 PM (GMT -7)   
I'm going off of the Phase II results from Osiris Therapeutics: http://investor.osiris.com/releasedetail.cfm?Releaseid=215300

And, my GI was the principal investigator for the trial until he switched his practice to a different hospital, and he mentioned that the trials were looking good so far when we discussed it at my last appointment.
Crohn's Disease diagnosed March 8th, 2006
Failed medications: Prednisone, Imuran, Remicade, Humira, Tysabri
Hoping to get into the Phase III Prochymal trials


northernguy
Regular Member


Date Joined Oct 2007
Total Posts : 39
   Posted 3/16/2009 1:33 AM (GMT -7)   
Hi all I haven't posted in a long time now but was just going to give an update.
I will be going down to Minneapolis , MN for my one year follow up visit in the
Prochymal study. I wish they would hurry up and approve it already. I did work
for me , there is no other way that i could have just gained like 20 pounds or so in
a months time without being on any other therapy. I did notice that it wore off after
about a month and a half , so i was put into the second arm of the study and was
randomized again. I did not get any benefit off of the second arm but am still completing
the one and two year follow ups. Anyways, I wish more people would know about this trial or
actually enroll in it if they were aware. It needs to get approved , wonder when that will be though????

northernguy
Regular Member


Date Joined Oct 2007
Total Posts : 39
   Posted 3/16/2009 11:07 PM (GMT -7)   
Hi , is there anybody out there that has had any similiar success in the Prochymal phase III trial.
i posted the previous comment but there wasnt any response. Also, ( onebloodonelife)/ Is your GI doc
Dr. Chris Shepela in Minneapolis? Thats who I have and he was also my doc at the U of M while I was
getting the Prochymal. Hes a really good doc in my opinion!


Cole

vls
Regular Member


Date Joined May 2005
Total Posts : 166
   Posted 3/17/2009 5:50 AM (GMT -7)   
I'm currently in the study but I'm ready to drop out.  I went thru two colonoscopies, cat scan, upper endoscopy, countless blood work (I think we're up to 25 vials so far) the four infusions and got worse.  During the prep last week for the colonoscopy, I had dry heaves until I finally vomited diarrhea!  An all time low.  Do you think they care...they took their 50 biopsies and more blood even though I couldn't even walk or talk due to being so anemic and dehydrated.  I'm a walking specimen to them, thats it.

sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 3/17/2009 9:16 AM (GMT -7)   
Yes, my story was quite similar to yours, northernguy. I had great success with the first randomization but got no benefit from the second. I am looking at my 2-year follow up in Sept.

I started Cimzia 5 weeks ago today and at first I thought it might be helping... Now I am bad again. So it was the steroids (once again) NOT the Cimzia. I can't wait for Prochymal to be approved. It's the only thing that actually helps me besides the poison of steroids. I think I believe that they are close... I read that the final data is expected to be submitted to the FDA in '09. With fast track maybe the latest would be mid-10? I sure hope so!!

v.scho - the trial does take many tests, especially if you're at a colonoscopy center. (I was) The two colonoscopies and the CT scan and all the blood work... It's a lot. I'm so sorry it's been so hard. I really believe that the cells do work... So hold hope on them for later. Maybe you could ask if there is going to be an open label? Maybe if you heard good news and completed the requirements (sounds like you almost have) that you could get in on something like that?

Hang in there! I feel like a rat in every trial I join. Just remember that *every* other Crohnie out there appreciates what you are doing. You are helping move the process for effective cures along.
--40 year old female, dx as UC in '04 (1st symptoms in '03), switched to Crohn's in '05, 1 fistula, crohn's colitis, limited to large intestine  --rejected (reaction/didn't work): Asacol, AZA, 6-MP, MTX, Remicade, Humira, prednisone
--Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08 => STOPPED 10/3/08 - now 2 months into it & it was the right decision
--currently taking budesonide suppositories, 3mg at night.  SLIPPING big time.  Started Cimzia first dose 2/10/09.  Dx Osteoporosis 10/08 started Forteo 1/27/09
--single mom to 11-yr-old girl


vls
Regular Member


Date Joined May 2005
Total Posts : 166
   Posted 3/18/2009 5:40 AM (GMT -7)   
they told me that the open label wouldn't be available to us for two years. Is that your understanding?

sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 3/18/2009 7:25 AM (GMT -7)   
yes, two years from the first infusion. I was wondering if it would be different for people who did not enter the second phase. I figure it's partly a safety issue - make sure there are no ill effects 2 years post med.
--40 year old female, dx as UC in '04 (1st symptoms in '03), switched to Crohn's in '05, 1 fistula, crohn's colitis, limited to large intestine  --rejected (reaction/didn't work): Asacol, AZA, 6-MP, MTX, Remicade, Humira, prednisone
--Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08 => STOPPED 10/3/08 - now 2 months into it & it was the right decision
--currently taking budesonide suppositories, 3mg at night.  SLIPPING big time.  Started Cimzia first dose 2/10/09.  Dx Osteoporosis 10/08 started Forteo 1/27/09
--single mom to 11-yr-old girl


onebloodonelife
Veteran Member


Date Joined Feb 2006
Total Posts : 842
   Posted 3/18/2009 2:02 PM (GMT -7)   
northernguy said...
Hi , is there anybody out there that has had any similiar success in the Prochymal phase III trial.
i posted the previous comment but there wasnt any response. Also, ( onebloodonelife)/ Is your GI doc
Dr. Chris Shepela in Minneapolis? Thats who I have and he was also my doc at the U of M while I was
getting the Prochymal. Hes a really good doc in my opinion!


Cole


Hi Cole! Yep, you're correct, I do see Dr. Chris Shepela. :-) Did you move to Healthpartners with him when he switched practices? He's absolutely fantastic, I agree! He definitely knows what he's doing, and he's so nice and helpful all the time.

I've got until April 14th before I can actually start the screening for the trial...that'll be the 90 day mark since my last Tysabri infusion. What was your experience doing all of that? I spoke to Jen, the nurse at the U, already, and she seemed to be very nice as well, and she was extremely excited to get a referral to the trial, especially from Dr. Shepela.
Crohn's Disease diagnosed March 8th, 2006
Failed medications: Prednisone, Imuran, Remicade, Humira, Tysabri
Hoping to get into the Phase III Prochymal trials

Post Edited (onebloodonelife) : 3/18/2009 7:23:11 PM (GMT-6)


carolinacroniegirl
New Member


Date Joined Mar 2009
Total Posts : 6
   Posted 3/18/2009 3:14 PM (GMT -7)   
I too am looking into this study. I have passed the first screening, waiting on the next. I am scared, nervous, and excited. Anyone with any thoughts or suggestions? I am in my reproductive years, this is my major concern.

jmiller056
Regular Member


Date Joined Feb 2009
Total Posts : 57
   Posted 3/18/2009 6:13 PM (GMT -7)   
Does anyone know how long after open label a drug is approved for the general market? Also, does anyone know approximately when we might expect Prochymal to be FDA approved?
Dx Crohn's Disease in 2001 at age 14. Lost 3 inches of colon and 7 inches of ileum in 2004 bowel resection.

CD returns in October 2008 at age 22.

Current meds: Pentasa: 3000 mg; Fibercon: 2 pills 3x; Imodium: 2 pills 3x

Ineffective Drugs: Imuran, Entocort, Remicade

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