Stem Cell Transplant Starts Tomorrow - Osiris Prochymal

Tomorrow is my first infusion/transfusion Prochymal. I am really nervous. I am in the Phase III study. Prochymal is in clinical trials and not yet an approved and marketed therapy. To date, MSCs have been tested in multiple indications in over 400 patients and no major safety concerns have been encountered.

Many of the readers of this Crohn's Blog have asked me how they can participate.
For more info, please send an email, including the nearest major city, to IBD@Osiris.com. We will contact you about participating sites in your area.

Phase II Results:
Prochymal Crohn's Disease Phase II Clinical Trial DataThis Phase II trial has completed enrollment.The objective of this study was to establish the safety and efficacy of two doses of Prochymal one week apart in patients experiencing moderate-to-severe Crohn’s disease that is refractory to steroids and immune suppression.

Trial Overview
Ten patients were enrolled in the trial. Male and female patients were eligible and must have been between the ages of 18 and 70. Patients must have had moderate-to-severe Crohn’s disease that was refractory to steroids and immune suppression.

Trial Highlights
- Patients in the trial received two doses of Prochymal within 7 days. All patients had moderate to severe Crohn’s disease and were not responding to standard medications (steroids, immunosuppressants, and biologics).
- Every patient evaluated in the trial had a statistically significant reduction in disease severity by day 28, with relatively low doses of Prochymal and a short treatment course.
Improvement was rapid with a reduction in disease severity on day 7.
- There appeared to be a positive correlation between dose and response: Those patients receiving more Prochymal had a better outcome.
- The treatment was well tolerated with no severe adverse events attributed to Prochymal.

Osiris Stem Cell Therapy - I am in the Study!

So I got the good news/bad news that my CT Scan shows an active Crohn's Flare Up. I completed my CDAI workbook and I am in. The study is being held by Osiris. The study is for Prochymal. I am really excited and I believe my first transfusion is next Thursday! Hopefully I see some quick results.

CT Scan's Are So Much Fun

So I had my CT Scan for this Stem Cell study thing. It was so much fun. They missed my vein with the contrast and sprayed it all through my arm...which led to a nice big bruise and pain for about 2 hours. Then they hit my black and blue arm (from last week's massive blood draw) with the next IV attempt. Rolled the vein the first time, so they redid it for a total of 3 IV pricks. Anyways, so much fun! I am thankful for the support I had yesterday though :-).

Signs that You are a Chronie! (Ahh, Love Crohn's Disease Jokes)

So one of my loyal blog readers (future trophy wife) posted this on Myspace and I had to share. Oddly enough I can relate to some of these but I feel your pain on the others! Keep smiling Chronies!

• You have a whole shelf in your pantry dedicated to your meds
• You can tell what part of your GI tract is off kilter today by the sounds..
• when you tell the phlebotomist, "trust me, thats not a good vein. no, you don't want to poke there either..."your grandparents ask you what they can expect when they go in for their first colonoscopy
• you can clench your buttcheeks so hard you are sure if you put coal in there you could make a diamond
• Your not a med student but your bookcase is 75% medical texts.
• Every skin rash triggers an emotional crisis!
• If You have larger clothes for bloated days..
• Your family comes to you for medical advice.
• You desperately wish Ensure came in more than 3 or 4 flavors..
• you stock up on clear liquids for flares or tests
• You look like you're 6 months pregnant by bedtime.
• When your cats feel sorry for you and cuddle up close to comfort you.
• You would never say I have a "stomach ache," but are more likely to say "my right lower quadrant is hurting," or "my inflamed ileum is giving me trouble!"
• You know the ER staff and all your doc's offices people by first name without having to look
• you are the only person you know that actually wants to eat salad but can'tyou have ever heard" i had the flu last week so I know what you are going through"Scrubbing Bubbles go on strike.The Tidy Bowl man leaves a "Dear John" letter.
• you see your undigested lunch bits in the toilet less than an hour after you ate it.
• you have a heating pad next to your bed for those painful nights.your husband looks at your *** and doesn't get turned on.
• You've fantasized about having a time machine for the express purpose of hunting down whoever developed Prednisone.
• you can run, unzip, unbutton, untie, and unbuckle all at the same time
• Mike Rowe refused to clean your toilet for the "Dirty Jobs" showyou feel faint when someones says," Oh Crap"….
• you take handfuls of pills at a time,you can swallow 15 pills in one swig of wateryou pay Doctor bills on a monthly basis
• you know the location of every bathroom in you local target, walmart, supermarket, etc
• You've ever "accidentally" let out a silent-but-deadly just to hurry the meeting along or for revenge on the guy who always says "just one more thing" when everyone else is ready to go.
• Your family and friends have fitted body armor and battle plans for those times they have to go Prednisone DEFCON 1 again.

Big Doctors Appointment Today - Details on Clinical Stem Cell Trial

So today I go to see if I qualify for a clinical trial that would involve a fairly non-invasive blood and bone marrow transplant for my Crohn's. UPDATE: I AM IN! I GET MY FIRST INFUSION IN TWO WEEKS. TODAY I DID A TB TEST, EKG, BLOODWORK, B12, AND A 1 HOUR INTERVIEW. I HAVE A CT SCAN TUESDAY AND AS LONG AS THAT SHOWS ACTIVE CROHNS I AM READY TO GO. I should qualify based on my lack of response to most other treatments. I think the details below are for the actual study I would be getting involved in. Right now, I have been under quite a bit of stress and am on the brink or at the beginning of a flare-up. I've been eating pretty light and eased off the drinking a bit in an effort to get in shape and keep my Crohn's at bay. I am so used to dealing with the pain by now (without the aid of painkillers for the past few weeks) that I don't even realize how much I actually hurt. I think that mental focus and disassociation keeps me feeling better. As I move forward with my divorce and new relationships I know that I need to take better care of myself and better educate those around me about Crohn's Disease. Sure, I guess it may be embarassing as I move on with dating, etc but the right person isn't going to get caught up in the minutiae and will understand.

Also, thanks to you all for your support of this site. I am proud to be able to educate, assist, and commiserate with you all!



This Phase III study is a multi-center, placebo-controlled, double-blind study of the safety and efficacy of Prochymal™ IV (ex-vivo cultured adult human mesenchymal stem cells) to treat moderate-to-severe, treatment-refractory Crohn’s disease.
Patients who are eligible and willing will be entered into two studies. If there is response at 28 days to protocol 603 and the Crohn's disease activity index (CDAI) is over 220, subjects are eligible to be re-randomized and receive Prochymal in protocol 610. Both protocols 603 and 610 involve four intravenous infusions within 14 days, with a safety follow-ups for two years.
Eligibility
Inclusion criteria:
Inadequate response, lost response, or documented intolerance to steroids, immunosupressants, and biologics (within the past 24 months)
Between 18 and 70 in age
Between 88 and 330 lbs in weight
Diagnosis of Crohn’s ileocolitis, colitis, or ileitis
CDAI between 250 and 450
Exclusion criteria:
Permanent colostomy or ileostomy
Active infection with HIV, hepatitis B or C, or clostridium difficile-associated disease
Obstructive fibrostenotic Crohn’s disease requiring hospitalization within three months of study enrollment
History of total proctocolectomy or subtotal colectomy with ileorectal anastomosis
Prednisone greater than 20 mg per day within 28 days of enrollment

Stress and Crohn's aka The Impact of Divorce on Crohn's

So I know this guy (cough, cough) that has Crohn's Disease and is going throughthe begininng stages of a divorce. Seems like every time he is stressed out his Crohn's Disease flares up. Nutrition is his main problem right now. He has loss 10 pounds mostly because he can't stomach food. Yesterday's nutrition consisted of a smoothie with protein powder, 4 Coors lights, and a half a peanut butter sandwich. Stress. Divorce stuff, financial obligations, AC broke and house is 92 degrees, dogs neglected and lashing out, work is crazy, he misses his daughter, etc. Oddly enough my...uh his health is actually pretty good. Started taking vitamins today to get some nutrients in my system. Workouts are suffering due to lack of fuel but still got in a fast 2 miles yesterday. Haven't had time for gym. Hopefully tonight. Anyhow, I am wondering if the inability to eat much is keeping the Crohn's at bay. Not taking ANY painkillers and am barely taking Pentasa. Missed an appointment for Stem Cell study at Dr. Shafrans....they are gonna be pissed...Anyways...he's gonna be allright in the long run. Everyone involved will be better off.