Crohn’s disease (regional enteritis or ileitis) is an inflammatory bowel disease (IBD). Known to cause ulceration’s (Breaks in the lining) of the small and large intestines, but if can affect any part of the digestive tract, from the mouth to the anus. Continuous inflammation causes intestinal wall to become thick. Usually occurs in the lower part of the small intestines (ileum). Crohn’s disease can be difficult to diagnose, because its symptoms are similar to other intestinal disorders, including ulcerative colitis (Cause inflammation and ulcers in the top layer of the lining of the large intestines.) The disease fluctuate, between periods of inactivity (remission) and relapse, cause pain and make the intestines empty frequently (bowl movement), resulting in diarrhea. Also, symptoms include rectal bleeding, weight loss, fatigue, and fever. Crohn’s disease in children may delay development and stunt growth. Also, cause abnormalities of the immune system and sores or ulcers, affecting the surrounding tissues of the bladder, vagina or skin. Documented in cases of Crohn’s disease, nutritional deficiencies (protein, calories and vitamins), and inflammation of the eyes or mouth, kidney stones, gallstones or diseases of the liver.
Crohn’s disease affects approximately 500,000 to two million people in the United States. Commonly starts during adolescence and early adulthood, but it can begin during childhood and later in life. Twenty percent probability the disease has hereditary link or seem to run in some families. People of Jewish heritage have an increased risk developing Crohn’s disease, and African Americans have a decreased risk for inheriting this disease. Reported in the Medical Journal Gut (2007), according to Dr. Paris P. Tekkis, from St. Mary Hospital in London, and colleagues, analyzed data from 12 studies on the topic of Crohn’s disease: Approximately twice likely (increase risk) adverse pregnancy outcomes, including premature birth and birth defects. Scientists continue to search for the genetic mutation that triggers Crohn’s disease. Tests to diagnosis and confirm Crohn’s disease include blood tests, upper gastrointestinal (GI) series (Examination of the small intestines) and endoscope (Inserting a long flexible, lighted tube linked to a computer TV monitor — into the anus to observe for any inflammation or bleeding in the large intestines. During the procedure, a tissue biopsy (from the lining of the intestine) may be taken, and examined under the microscope. Variety of drugs available, treat the symptoms of Crohn’s disease and bring about long — term remission. Also dietary adjustments and surgery maybe considered, remove part of the intestine (Only temporary solution) or removal of the colon or large intestine (colectomy – Surgical procedure by which an opening is made through the skin to allow intestinal contents to drain from the opening into a sealed pouch). Crohn’s disease patients can live active or normal life’s (raise families and hold jobs), despite the need to take medication for long periods of time and occasional hospitalization.
In January 2007, the Food and Drug Administration granted Osiris Therapeutics Incorporated, fast track status (Process for interacting with FDA during drug development, so that product can reach approval more rapidly for serious and life threatening conditions.) for its stem cell therapy, Prochymal to treat Crohn’s disease that does not respond to standard therapies, during a Phase Three clinical trial (late stage). During this trial stage, initially 258 subjects are scheduled to be enrolled, and will receive a high dose of Prochymal, low dose of Prochymal or a placebo. The drug provides anti-inflammatory treatment and facilitates the repair of previously damaged tissue (promote tissue regeneration). Prior to development of Prochymal, Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, noted that there have been no satisfactory treatments for children with Crohen’s disease, who have moderate to severe disease activity, despite traditional and conventional therapies. In 2005, the FDA granted Osiris fast track status for the developing Prochymal to treat dangerous reaction to bone narrow transplant called GVHD (grat-versus-host disease), affects about 4,500 Americans. Currently, Osiris is enrolling patients in a Phase Three trial for the use of Prochymal for resistant GVHD. In October 2006, Osiris Therapeutics provided results from a study, showing that Prochymal reduced the symptoms of inflammation in Crohn’s patients. Eventually, when Prochymal gets approval for marketing and sale from the FDA, it will become first full — fledged stem — cell drug to reach the market. Analyst Eun K. Yang at Jeffries & Company, predicts Prochymal sales for the treatment of Crohn’s disease will reach about one billion dollars (Estimated cost $20,000 for 50,000 treated patients)