Mesenchymal stem cells for Ileocolitis
This study is evaluating whether stem cells may help heal fistulas in individuals with Crohn's disease.
See full descriptionAbout the trial for Ileocolitis
Treatment Groups
This trial involves 2 different treatments. Mesenchymal Stem Cells is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and younger. You must have received 1 prior treatment for Ileocolitis or one of the other 3 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Mesenchymal stem cells will improve 1 primary outcome and 4 secondary outcomes in patients with Ileocolitis. Measurement will happen over the course of Month 12.
Patient Q & A Section
What are the common side effects of mesenchymal stem cells?
The most common and important side effects of MSCs are fever, hemorrhage, skin toxicity, and infection. Symptoms other than these three may vary depending on the source, condition, injection, and dosage.
What is ileocolitis?
Ileocolitis is often a diagnosis of exclusion. Patients with symptoms suggestive of IBD, such as diarrhea and/or fever with nausea and/or vomiting, usually have a positive colonoscopy and biopsy. It is important to consider other potential causes of symptoms, such as microscopic colitis. In patients with severe, refractory disease, a diagnosis of intestinal lymphoma may be considered. If the endoscopy shows ulcers in the cecum or ascending colon, intestinal biopsy may be necessary.
What causes ileocolitis?
While a variety of factors can cause ileocolitis, medications can be a primary cause. Other factors may also play a role. More information about ileocolitis is needed to help manage the disease.
Can ileocolitis be cured?
In a recent study, findings demonstrates that the symptoms of ileocolitis are not cured. In most patients treatment should be continued on an ongoing basis and that patients with ileocolitis and comorbidity should have prompt follow-up. In others, it is possible the patient with ileocolitis could potentially be successfully treated with a steroid-sparing immunomodulation therapy. Further research should determine if other immune system manipulations such as antiadhesion molecules, probiotics, or antifungals can improve symptom control in patients with ileocolitis.
What are the signs of ileocolitis?
The signs of ileocolitis are the same as those of IBD including altered stool frequency and consistency, blood in the toilet, abdominal pain and changes of the stool color. These observations are important for differential diagnosis in patients presenting with diarrhea or abdominal discomfort.
How many people get ileocolitis a year in the United States?
In the United States, from the years 1975-1999, the total incidence of UC is estimated to be 19.5-29.3 per 10,000 population. UC is more frequent in men (30.4 per 10,000 persons) than in women (17.0 per 10,000 persons). The number of patients with complicated UC is larger in patients with ileal than with colonic disease (37.9 per 10,000 for UC with colonic vs. 23.1 per 10,000 for UC with ileal or proctitis): patients with UC with ileal/proctitis have a 10-fold higher risk for complicated disease than UC with only colonic disease.
What are common treatments for ileocolitis?
The most common treatment for ileocolitis is oral treatment and topical lubricants with analgesics, usually diclofenac. Steroids may be prescribed if there are severe symptoms. Antibiotics and antifungals are not usually used.\n
What is the latest research for ileocolitis?
Ileocolitis has been used as a name for various forms of chronic inflammatory bowel disease, although there remains no evidence that they are distinct entities. If they are distinct, different types of ileocolitis or intestinal inflammation may be relevant. Some evidence supports the idea that bacterial triggers are involved in the development of chronic ileocolitis and the potential clinical utility of bacterial therapy.
What is the primary cause of ileocolitis?
[Primary ileocolitis is due to ileal and colorectal atrophy; secondary ileocolitis is due to colonic mucosal changes in patients with prior ileocolonic diseases.] This is the first report in the literature to describe the histopathological features of ileo-colitis. [A histopathopathological grading of ileocolitis can be used in clinical practice to diagnose the degree of ileal and colorectal atrophy and, consequently, the necessity to prescribe different drugs to correct it. If a patient needs surgical intervention for an ileo-colic disorder; the use of a strict grading scheme is very important.
What are the latest developments in mesenchymal stem cells for therapeutic use?
Stem cells have the ability to integrate with other cell types and induce new tissues, as well as to promote endogenous repair of damaged tissue. Therefore, stem cells are the most exciting field for advances in stem cells for therapeutic use. Furthermore, the use of biocompatible materials is gaining interest and helps to create better implants without compromising the physical integrity.
Have there been any new discoveries for treating ileocolitis?
There was no new drug in the treatment of ileocolitis. There was a case reported of a novel treatment of ileocolitis that is in the trial stage. There are some interesting findings in regards to the pathohistopathologic lesions seen in ileocolic disease.
Is mesenchymal stem cells safe for people?
The use of bone marrow MSCs in people with IBD has a narrow safety margin and, thus, should be considered with caution even if approved by a health authority.