Prochymal - stem cell therapy on the horizon

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Glad Bag
Veteran Member


Date Joined Mar 2007
Total Posts : 699
   Posted 7/19/2007 11:04 AM (GMT -7)   
check it out.......

i noticed another post earlier about Cimzia....

how about this.....i find this to be the most promising therapy i have seen yet...i can't wait for them to shoot me full of someone else's stem cells! yippee!

set health mode: rebuild damaged tissue


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http://www.osiris.com/clinical_trials_prochymal_crohns.php

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Prochymal Crohn's Disease Clinical Trial

This trial has completed patient enrollment.

For further information or to inquire about possible future trials, send an e-mail to IBD@Osiris.com.


Crohn's Disease Treatment
Crohn's Disease is a chronic, life-long condition with relapsing inflammation of the bowels and gastrointenstinal tract. Its fundamental cause is unknown, but it is suspected to come from a genetic predisposition of the body’s overreaction to the environment, items in the diet, or an infection. Severe Crohn's Disease can cause pain, undesirable changes in lifestyle, hospitalizations, and side-effects from medications used for treatment. While Crohn's Disease often first occurs in people between the ages of 20 and 30, it can occur in children or at any other age. In the majority of sufferers, it requires surgery at least once. Over 500,000 people in the U.S. are afflicted with Crohn's Disease, and approximately 20,000 new cases are diagnosed each year.

Osiris has recently completed enrollment in a trial using Prochymal to explore whether it reduces the symptoms of moderate-to-severe Crohn’s Disease.

This trial involved a particular type of adult stem cell, called a Mesenchymal Stem Cell (MSC) which has shown promise in the treatment of inflammatory diseases. These cells are derived from healthy adult volunteer bone marrow donors.

Patients in the trial received two doses of MSCs 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™.

Your Options
It is vitally important that we continue to find new effective ways to treat individuals who develop Crohn's Disease. By participating in clinical trials, you can make an invaluable contribution to others experiencing Crohn's Disease.

Prochymal™ - Frequently Asked Questions

1. What is the therapy?
2. What does Prochymal™ do?
3. Is Prochymal™ Safe?
4. Can the cells go to other areas of the body?
5. What will my treatment be in this trial?
6. Would it cost me anything to participate in this study?
7. Would I be paid if I decided to join this study?
8. What are the risks if I participate?
9. How do I participate?


Q: What is the therapy?

A: The active ingredient of Prochymal™, the investigational therapy in this study, is adult Mesenchymal Stem Cells (MSCs). The cells in this product are from normal healthy adult volunteer donors, and are not derived from a fetus, embryo or animal. Studies have shown that these cells are universally compatible. Similar to Blood Type O, these MSCs may be used without tissue type matching for specific patients. Prochymal™ is produced in a controlled setting and is tested for possible infectious agents (such as viruses, bacteria, etc) before it is given by infusion into a vein.
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Q: What does Prochymal™ do?

A: Animal studies have shown that MSCs move to damaged areas of your body. The MSCs interact with the immune cells in your body, reducing inflammation and assisting in tissue repair.
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Q: Is Prochymal™ Safe?

A: Based on previous human safety data, Prochymal™ has been approved by FDA for investigational use in humans. Prochymal™ is in clinical trials and not yet an FDA approved and marketed therapy. MSCs have been administered to over 100 patients who received bone marrow transplants in previous clinical trials to treat GVHD.
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Q: Can the cells go to other areas of the body?

A: When MSCs are injected into animals that do not have damaged tissues, the cells return to the bone marrow where they were originally located. If tissue damage is induced, the cells then leave the bone marrow and travel to those damaged tissues. These cells have been studied for different diseases and have been shown to follow inflammatory signals to various areas of the body to aid in repair.
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Q: What will my treatment be in this trial?

A: Patient enrollment in this trial is complete, but those who participated received two Prochymal™ treatments. They underwent tests prior to and at various timepoints after treatment to monitor any changes in Crohn's disease symptoms.
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Q: Would it cost me anything to participate in future studies?

A: The study sponsor will pay for the procedures, tests and treatments performed for research purposes. The expense of any procedures, tests or treatments related to your normal medical care would be billed to you or your insurance in the regular way. You would not be charged to be in this research study.
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Q: Would I be paid if I decided to join future studies?

A: People who decide to participate in the study are not paid for their participation. Some sites may offer compensation for expenses incurred during study visits such as parking vouchers, meal vouchers etc., however, this compensation is not guaranteed.
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Q: What are the risks of participation?

A: Any associated risks are fully explained to participants by the physician before trial entry.
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Q: How do I participate?

A: Enrollment for this Phase II study is complete.
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Future studies are being designed. Please send e-mail to IBD@Osiris.com to be contacted about future studies, or for more informatio

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Orphan Drug Adult Stem Cell Product (Prochymal) for GVHD

On December 20, 2005, the FDA approved orphan drug status for an adult stem cell product (Prochymal, made by Osiris Therapeutics, Inc) in the treatment of acute graft-versus-host disease (GVHD). The product was previously granted fast-track status in January 2005.

GVHD is a potentially fatal form of immune rejection that affects approximately 50% of patients who receive an allogenic hematopoietic stem cell transplant for the treatment of cancers such as leukemia and lymphoma. In many cases, acute GVHD is refractory to steroids and immunosuppressive agents that are the current standard of care.

According to a company news release, the product is a formulation of human mesenchymal stem cells that modulates the inflammatory response via 2 mechanisms: decreasing the production of pro-inflammatory cytokines while increasing levels of anti-inflammatory cytokines; and reducing T-cell proliferation rates.

In addition, the stem cells have demonstrated an ability to migrate to sites of inflammation and tissue damage, where they facilitate the repair process. In patients with GVHD, use of the product has reduced diarrhea, improved ulcerations in the intestinal lining, and healed skin lesions.

The company is currently enrolling patients in 2 ongoing phase 2, placebo-controlled clinical trials designed to evaluate product efficacy at 2 dose levels in patients with acute and severe acute GVHD receiving standard steroid therapy.

The product is also being studied for use in other immunologic disease applications such as Crohn's disease.

Save yourselves.....do something crazy! download videochat from camfrog.com
my id is: natglad1 i'll see you in cyberspace..also find me on myspace.com/nathanael_glad aka Ned Flanders
****oh, yeah....my illness/symptoms/progression....ummm...it sucks....let's just say I put the "Bag" in "GladBag" ok! / diagnosed at age 15, i have made it to 30 now (yeehaw), temp. ileostomy 4/20/07 due to multiple, persistent fistulas of the worst imaginable variety....any fistula sucks if you ask me..but now that I had surgery....I am loving live..for the most part..if I could only find a new girlfriend
Save yourselves.....do something crazy! download videochat from camfrog.com
my id is: natglad1 i'll see you in cyberspace..also find me on myspace.com/nathanael_glad aka Ned Flanders
****oh, yeah....my illness/symptoms/progression....ummm...it sucks....let's just say I put the "Bag" in "GladBag" ok! / diagnosed at age 15, i have made it to 30 now (yeehaw), temp. ileostomy 4/20/07 due to multiple, persistent fistulas of the worst imaginable variety....any fistula sucks if you ask me..but now that I had surgery....I am loving live..for the most part..if I could only find a new girlfriend

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