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NIDDK Launches New CellCept Phase III Clinical Trial This Month!

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  • NIDDK Launches New CellCept Phase III Clinical Trial This Month!

    NIDDK Launches Phase III CellCept Study

    The purpose of this study is to investigate the safety and effectiveness of a medication called CellCept in treating refractory (has not responded to other treatments) interstitial cystitis. Inotherwords, this is a study for patients who have more severe IC that have not responded to any therapies. In addition, they must have been diagnosed with a hydrodistention/cystoscopy.

    CellCept is an immuno-suppressant. Immuno-suppressants work in the body by reducing the immune system’s ability to produce certain reactions that can cause inflammation. In some people, the inflammation produced by their immune system can damage healthy tissues and cause symptoms of pain and discomfort. CellCept is approved by the U.S. Food and Drug Administration (FDA) for use in patients who have had an organ transplant and helps to prevent the rejection of the transplanted organ.

    The study will be conducted at eleven research centers throughout the USA & Canada.

    For more info and a complete list of research centers, please visit:
    http://www.clinicaltrials.gov/ct/sho...451867?order=6
    Would you like to talk with someone about your IC struggles? The ICN now offers personal coaching sessions that include myself, Julie Beyer RD on the diet and Dr. Heather Howard on Sexuality. http://www.icnsales.com/icn-personal-coaching/

    Looking for books, magazines & reports on IC? Please visit the ICN Shop at: http://www.icnsales.com: Your ICN subscription & purchases in our shop support these message boards, chats and special events. BECOME AN ICN ANGEL TODAY!

    Please remember that the information on the ICN is provided with the understanding that ICN, its founder, staff, volunteers, and participants are not engaged in rendering medical or professional medical services. We cannot and do not give medical advice. Only your personal physician can do this for you.







  • #2
    That's awesome! It sounds a lot like cyclosporine A, huh?
    current meds:
    cytotec 200mcg twice daily
    toprol
    allegra

    ONLY 3 MEDICATIONS!!! YAY! Would never have dreamed this is possible

    dx: hashimoto's thyroiditis 1998
    dx: interstitial cystitis via cystoscopy with hydrodistention and biopsy 2003
    dx: endometriosis 2003
    dx: innapropriate sinus tacchicardia 2005

    meds tried but failed:
    elavil (6months)- severe tachycardia
    elmiron (1yr6mo.)- no improvement, nausea, hair loss, stomach ulcers
    a bunch of others



    Me and my best friend's baby (also my Godson!)

    Comment


    • #3
      Oh wow! I really feel that this is what is going on with me. My dad and my grandma had autoimmune issues as well, my dad still does.

      It's so hard. I hope they find answers soon.
      http://www.TheCraftyEwe.etsy.com

      Comment


      • #4
        I love to see posts like this. They give me hope! Let's hope that cellcept is our miracle:-) My dream is to get off of Elavil. I have a love/hate relationship with the drug. I love how it controls my symptoms and helps me to lead a normal life. However, I hate how tired and fat I am on it! -V
        Blessings and Hope

        Current Meds.
        OFF MY MEDS
        Vivelle Dot: .10 changed every 72 hours
        Compoounded Progesterone 25mg/night

        Current Supplements
        Hydroeye: 2 pills AM

        Diagnosed
        1995: Endometriosis
        1998: Interstitial Cystitis
        2006: Bladder Endometriosis, Total Hysterectomy and Bowel Re-Section
        2008: Removal of Ovarian Remnant and Endometrial Cyst That was Obstructing Ureter
        2012: Laparoscopic Removal of Adhesions and Staples

        Comment


        • #5
          This is great news! What I find heartening, too, is the knowledge that some IC patients (especially those of us with severe IC) do NOT respond to the usual treatments. I was told by my urogyn, Dr. T., that I was his "only patient not to respond to the usual treatments." This was told to me with a look of supreme annoyance on his face, and I think he formed the opinion right then and there that I was a crazy patient - that it was impossible for the standard treatments not to work.

          I think that is a big part of why he collaborated with the psychologist-in-training to give me the 307.89 (the IC is all in your head) diagnosis.

          Hopefully it is starting to become common knowledge, now, at long last, that some of us do not respond to ANY of the traditional treatments.

          Blessings,
          Lori

          Comment


          • #6
            Lori- Did Elavil help you at all? -Vicki
            Blessings and Hope

            Current Meds.
            OFF MY MEDS
            Vivelle Dot: .10 changed every 72 hours
            Compoounded Progesterone 25mg/night

            Current Supplements
            Hydroeye: 2 pills AM

            Diagnosed
            1995: Endometriosis
            1998: Interstitial Cystitis
            2006: Bladder Endometriosis, Total Hysterectomy and Bowel Re-Section
            2008: Removal of Ovarian Remnant and Endometrial Cyst That was Obstructing Ureter
            2012: Laparoscopic Removal of Adhesions and Staples

            Comment


            • #7
              I got the following info off of safemedication.com Looks like cellcept(mycophenolate) has some potentially serious side effects and risks.




              Mycophenolate

              mye koe fen' oh late


              Other Names:CellCept
              Important Warning
              Mycophenolate may decrease your ability to fight infection. Wash your hands often and avoid people who are sick while you are taking this medication. If you experience any of the following symptoms, call your doctor immediately: sore throat; fever; chills; colds sores; blisters; swollen glands; extreme tiredness; loss of appetite; tingling or burning in one part of the body; general weak or sick feeling; and other signs of infection.

              Mycophenolate may increase your risk of developing certain types of cancer, including lymphoma (a type of cancer that develops in the lymph system) and skin cancer. Plan to avoid unnecessary or prolonged exposure to real and artificial sunlight and light therapy and to wear protective clothing, sunglasses, and sunscreen. This will decrease your risk of developing skin cancer. Call your doctor if you experience any of the following symptoms: pain or swelling in the neck, groin, or armpits; a change in the appearance of a mole; skin changes; or sores that do not heal. Talk to your doctor about the risks of taking mycophenolate.



              Why is this medication prescribed?

              Mycophenolate is used with other medications to prevent the body from rejecting kidney, heart, and liver transplants. Mycophenolate is in a class of medications called immunosuppressive agents. It works by weakening the body's immune system so it will not attack and reject the transplanted organ.

              How should this medicine be used?

              Mycophenolate comes as a capsule, a tablet, and a suspension (liquid) to take by mouth. It is usually taken twice a day on an empty stomach. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take mycophenolate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

              Swallow the tablets and capsules whole; do not split, chew, or crush them. Do not open the capsules.

              Do not mix mycophenolate liquid with any other medication.

              Be careful not to spill the liquid or to splash it onto your skin. If you do get the liquid on your skin, wash the area well with soap and water. If you get the liquid in your eyes, wash with plain water. Use wet paper towels to wipe up any spills.

              Mycophenolate prevents transplant rejection only as long as you are taking the medication. Continue to take mycophenolate even if you feel well. Do not stop taking mycophenolate without talking to your doctor.

              What special precautions should I follow?

              Before taking mycophenolate,

              tell your doctor and pharmacist if you are allergic to mycophenolate, mycophenolic acid, or any other medications.

              tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: acetazolamide (Diamox); acyclovir (Zovirax); antibiotics; azathioprine (Imuran); chlorothiazide (Diuril); cimetidine (Tagamet); cholestyramine (Questran); colestipol (Colestid); ethacrynic acid (Edecrin); furosemide (Lasix); ganciclovir (Cytovene); isoproterenol (Isuprel); meperidine (Demerol); morphine (MS Contin, MSIR, Oramorph); oral contraceptives (birth control pills); phenytoin (Dilantin); probenecid (Benemid); procainamide (Pronestyl); quinine; salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Trisalate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others) and salsalate (Argesic, Disalcid, Salgesic); and theophylline (TheoDur). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

              if you are taking antacids, take them 2 hours before or 4 hours after mycophenolate.

              tell your doctor if you have or have ever had Lesch-Nyhan or Keeley-Seegmiller syndrome (inherited diseases that cause high levels of a certain substance in the blood, joint pain, and problems with motion and behavior);any disease that affects your stomach, intestines, or digestive system; any type of cancer; phenylketonuria (an inherited diseases that requires patients to follow a special diet to prevent mental retardation); and liver or kidney disease.

              tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You must use two forms of birth control before beginning treatment with mycophenolate, during treatment, and for 6 weeks after treatment. Your doctor will not allow you to begin taking mycophenolate unless you have had a negative pregnancy test. If you become pregnant while you are taking mycophenolate, call your doctor immediately. Do not breastfeed while you are taking this medication.

              do not have any vaccinations (shots) without talking to your doctor.


              What special dietary instructions should I follow?

              Unless your doctor tells you otherwise, continue your normal diet.

              What should I do if I forget a dose?

              Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

              What side effects can this medication cause?

              Mycophenolate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

              diarrhea
              constipation
              stomach pain
              upset stomach
              vomiting
              difficulty falling asleep or staying asleep
              pain, especially in the back, muscles, or joints
              Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:

              swelling of the hands, feet, ankles, or lower legs
              difficulty breathing
              shaking hands that you cannot control
              unusual bruising or bleeding
              headache
              fast heartbeat
              excessive tiredness
              dizziness
              pale skin
              weakness
              black and tarry stools
              red blood in stools
              bloody vomit
              vomiting material that looks like coffee grounds
              loose, floppy muscles
              white patches in mouth or throat
              swelling of gums
              vision changes
              rash
              Mycophenolate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

              What storage conditions are needed for this medication?

              Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Mycophenolate liquid may also be stored in a refrigerator, but should not be frozen. Throw away any unused mycophenolate liquid after 60 days and throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

              What other information should I know?

              Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to mycophenolate.

              Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

              Selected Revisions January 2004.
              Blessings and Hope

              Current Meds.
              OFF MY MEDS
              Vivelle Dot: .10 changed every 72 hours
              Compoounded Progesterone 25mg/night

              Current Supplements
              Hydroeye: 2 pills AM

              Diagnosed
              1995: Endometriosis
              1998: Interstitial Cystitis
              2006: Bladder Endometriosis, Total Hysterectomy and Bowel Re-Section
              2008: Removal of Ovarian Remnant and Endometrial Cyst That was Obstructing Ureter
              2012: Laparoscopic Removal of Adhesions and Staples

              Comment


              • #8
                Lori- Did Elavil help you at all? -Vicki
                __________________
                Blessings and Hope

                Hi, Vicki, nope - Elavil (I tried Pamelor, too) increased my bladder pain greatly. It gave me an incredibly horrible flare, every single time (dozens of times) I've tried it. I have tried taking a smaller dose, tried a larger dose. Tried scraping the coating off the pills in case I was sensitive to dyes. Took the pills with a big glass of water, took the pills with Prelief.

                The tricyclics greatly increase my bladder pain for some reason. If you look at the old posts on the boards, you will see there is a very small minority of us IC'ers (usually the more severe cases) where we have this odd reaction to tricyclics and also antihistamines. It's as if our bladders are reacting in the opposite way.

                Perhaps it is because IC might be a collection of diseases all under the one umbrella term of IC. Perhaps my type of IC has this odd reaction to these medicines.

                Blessings,
                Lori

                Comment


                • #9
                  Vicki... I'm glad you posted the safety information. I was assuming that people would read the trial announcement which gives many exclusion criteria... which, to me atleast, suggested that there were risks with this therapy. On the otherhand, it is commonly and successfully used to prevent organ rejection in transplants. It's good to have the PRO's and CON's!!! I'm a huge believer of understanding the risk because I seem to be one of those people that react to almost everything!

                  jill
                  Would you like to talk with someone about your IC struggles? The ICN now offers personal coaching sessions that include myself, Julie Beyer RD on the diet and Dr. Heather Howard on Sexuality. http://www.icnsales.com/icn-personal-coaching/

                  Looking for books, magazines & reports on IC? Please visit the ICN Shop at: http://www.icnsales.com: Your ICN subscription & purchases in our shop support these message boards, chats and special events. BECOME AN ICN ANGEL TODAY!

                  Please remember that the information on the ICN is provided with the understanding that ICN, its founder, staff, volunteers, and participants are not engaged in rendering medical or professional medical services. We cannot and do not give medical advice. Only your personal physician can do this for you.






                  Comment


                  • #10
                    to my knowledge ALL immunosupressive drugs have these kind of side effects, though some seem to be even more dangerous than others.

                    I think that a lot of the volunteers will probably be helped by this stuff, which would only further support that IC (for some at least) is an autoimmune disorder. Unfortunately when side effects are this bad, people are put in a bad position no matter what.

                    ~*miz_sunshine87*~
                    19 y/o student, salesperson, fashionista, future high school teacher. <3 to sing and travel. Dream job= cruise ship entertainer
                    ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
                    My IC story- diagnosed at age 15 (Feb 2004), after approx. 6 mos of symptoms. Went into near complete remission following hydrodistention and introduction of meds. Feeling so good that I started skipping meds (bad idea). 1 week flare (May 2006). New flare November 2006-present.
                    ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
                    My triggers- I'm not sure about food triggers, just started IC diet but so far doesn't seem to be doing much. Stress is a big trigger for me though. Both flares this year came during stressful times. I think that stress reduction will help me immensely (last flare went AWAY during vacation in Mexico when I was drinking margaritas like they were water;P).
                    ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
                    Start of IC symptoms- Summer 2003 (after a UTI)
                    Dx- February 2004, after hydrodistension (ouch!)

                    Current treatments- Amytriptyline (25mg), Hydroxizine (25mg), MSM w/Glucosamine (1000mg,3x/day), quercetin (500mg, 2x/day), trying to stick to IC diet, prelief as needed.

                    Previous treatments- Amytriptyline (10mg), Hydroxizine (10mg), Alesse (HBC)

                    Comment


                    • #11
                      CellCept may put some people in a bad position, but it might be the drug that gives them their life back. If you have tried all of the conventional treatments like Elavil, Detrol, Ditropan, Prelief, Bladder Instills, etc. and some of the experimental treatments like Botox-A, CellCept or CyA are next on the possible treatment list. I am one of those people who has failed everything. I had Botox-A injections done 18 days ago and I feel like I did before the injections. I refuse to go on strong painkillers because I can't function while I'm taking them. I have been to hell and back in the past two years with trying to complete my bachelor's degree. I have put way too much time and effort into this degree to give up now. Many people think I have a hard decision to make. I can accept the IC symptoms and move on with my life or I can try some more experimental treatments. For me it is an easy decision. I am going to try some more experimental treatments just because I know I'm not crazy, nuts, or imagining my symptoms.

                      Comment


                      • #12
                        I didn't in any way mean that it was a bad idea to go on these experimental drugs. I just meant that it was unfortunate that they had such possible side effects.
                        I actually know quite a bit about immunosuppressives as my brother is on one. They really are a miracle in many ways.
                        I wish anyone who tries them the best of luck

                        ~*miz_sunshine87*~
                        19 y/o student, salesperson, fashionista, future high school teacher. <3 to sing and travel. Dream job= cruise ship entertainer
                        ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
                        My IC story- diagnosed at age 15 (Feb 2004), after approx. 6 mos of symptoms. Went into near complete remission following hydrodistention and introduction of meds. Feeling so good that I started skipping meds (bad idea). 1 week flare (May 2006). New flare November 2006-present.
                        ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
                        My triggers- I'm not sure about food triggers, just started IC diet but so far doesn't seem to be doing much. Stress is a big trigger for me though. Both flares this year came during stressful times. I think that stress reduction will help me immensely (last flare went AWAY during vacation in Mexico when I was drinking margaritas like they were water;P).
                        ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
                        Start of IC symptoms- Summer 2003 (after a UTI)
                        Dx- February 2004, after hydrodistension (ouch!)

                        Current treatments- Amytriptyline (25mg), Hydroxizine (25mg), MSM w/Glucosamine (1000mg,3x/day), quercetin (500mg, 2x/day), trying to stick to IC diet, prelief as needed.

                        Previous treatments- Amytriptyline (10mg), Hydroxizine (10mg), Alesse (HBC)

                        Comment


                        • #13
                          I have definitely had times in the last ten years where I would try anything no matter the side effects. Elavil is really the only thing that helps me. I've tried every instill, pill, hydrodistention, botox in the bladder and in the vaginal pelvic muscles, interstim, hormone drops, hormone patches, hormone creams, chiropractor, and nearly every herb known to man. Although I hate the side effects of Elavil, it is better than notbeing ableto leave house. If the Elavil stops working and cellcept is available, I am sure I'll try it. I just like to educate myself on the side effects of something so I know what's happening if I have those side effects. -Vicki
                          Blessings and Hope

                          Current Meds.
                          OFF MY MEDS
                          Vivelle Dot: .10 changed every 72 hours
                          Compoounded Progesterone 25mg/night

                          Current Supplements
                          Hydroeye: 2 pills AM

                          Diagnosed
                          1995: Endometriosis
                          1998: Interstitial Cystitis
                          2006: Bladder Endometriosis, Total Hysterectomy and Bowel Re-Section
                          2008: Removal of Ovarian Remnant and Endometrial Cyst That was Obstructing Ureter
                          2012: Laparoscopic Removal of Adhesions and Staples

                          Comment

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