CROHN'S DISEASE CLINICAL RESEARCH STUDY

We are seeking volunteers 18 to 70 years old who are currently experiencing symptoms of active Crohn's Disease.

PURPOSE OF THE STUDY:

To find out if the investigational study drug is safe and effective in patients with Crohn's Disease. Blood tests, physical exams, colonoscopies, and other tests, as well as a daily diary, will help answer this question.

STUDY DRUG INFORMATION:

The investigational study drug is called Prochymal™. Its active ingredient is adult Mesenchymal Stem Cells. The cells in this product are from normal healthy adult volunteer donors, and are not from a fetus, embryo or animal. Study participants will be randomized to receive four IV infusions of one of the following: a placebo (inactive substance), a high dose of Prochymal™, or a low dose of Prochymal™. The four infusions will be given over a 2 week period. Each infusion will last for approximately 60 minutes, followed by a 2 hour observation period.

STUDY INFORMATION:

• The study requires 4 visits to the clinic for the IV infusions. When the infusions are complete, follow-up visits will occur every 2 weeks for the next 6 weeks. Thereafter, there will be two periodic visits to the clinic over the next 2 years. If you respond well to this drug over the first month, you will be asked to make additional clinic visits over the next six months to monitor your progress. In addition, if your Crohn's disease comes back, you may be asked to receive more IV infusions in an effort to achieve the initial good result again.

• The following are 3 categories of treatment for Crohn's Disease (please see below for questions pertaining to these treatment categories):
  1. Steroids - Oral prednisone taper that began as a dose of at least 40 mg/day (or equivalent) with continuous use at any dose for at least 4 weeks OR oral budesonide at least 9 mg/day for at least 9 mg/day for at least 4 weeks
  2. Immunosuppressants - Azathioprine at least 2 mg/kg/day* for at least 12 weeks OR 6-mercaptopurine at least 1 mg/kg/day for at least 12 weeks OR methotrexate at least 15 mg/week for at least 12 weeks (*dose may be lower if 6-thioguanine nucleotide levels are documented as therapeutic (230-400 pmol/8x10 to the 8th power RBC)
  3. Biologics - Infliximab at least 5 mg/kg for at least 8 weeks OR adalimumab at least 40 mg every other week for at least 8 weeks OR certolizumab pegol at least 400 mg monthly for at least 8 weeks

I. Have you had a documented intolerance at any time to any of these drugs? (A documented intolerance would include the inability to achieve either therapeutic dosing or an adequate treatment duration due to side effects (such as leucopenia, abnormal transaminases, etc.) OR a documented intolerance would include an allergic reaction (such as anaphylaxis, immediate or delayed hypersensitivity reactions, or a comparable event).

II. AND/OR Have you experienced an inadequate or lost response (a recurrence or persistence of symptoms) while on any of these drugs within the past 24 months?

NOTE: To qualify for the study, you must meet one of the criteria in I or II above.

• There is no charge for participation (study procedures and study medication are no-cost).

• Principal Investigator: John Goff, M.D.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Western States Clinical Research, Inc.
Telephone: 303-940-0909 (Message Line)
FAX: 303-940-0308
E-mail: research@wscrinc.com  

Amber Bretz, Mary Reid, Jodi Frazier, Cheri Casey, or Dara Stillman

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Our mission is to promote the health and well-being of humanity by the development of new medicines through high-quality clinical research and a closely held philosophy of striving for excellence.

To find out about the studies that are currently underway at our office, please see Clinical Trials.

Western States Clinical Research Inc. specializes in research studies related to gastroenterology, asthma and allergy, pulmonology, internal medicine, women's health, ophthalmology and dermatology. Our website contains information for physicians, pharmaceutical companies and individuals interested in participating in clinical research.

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