CLINICAL TRIAL

Mesenchymal stem cells for Ileocolitis

Recruiting · < 18 · All Sexes · Cleveland, OH

This study is evaluating whether stem cells may help heal fistulas in individuals with Crohn's disease.

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About the trial for Ileocolitis

Eligible Conditions
Fistula · Perianal Fistula Due to Crohn's Disease (Disorder) · Crohn Disease · Disease

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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Mesenchymal stem cells
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesenchymal stem cells
2020
Completed Phase 2
~150

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Perianal fistula is a type of anal fistula that affects the skin around the anus show original
The participants in the study agreed to either use birth control or abstain from sex in order to avoid getting pregnant. show original
Can have an MR evaluation if you don't have any contraindications, like having a pacemaker or magnetically active metal fragments, or if you're claustrophobic. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Month 12
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Month 12.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Treatment related adverse events
MONTH 12
Number of participants with treatment related adverse events post-injection of 75 million allogeneic bone marrow derived MSC's for the treatment of perianal fistula(s) in the setting of Crohn's disease as assessed by protocol
Worsening of disease
MONTH 12
Number of participants with worsening of disease post-injection of 75 million allogeneic bone marrow derived MSC's for the treatment of perianal fistula(s) in the setting of Crohn's disease Worsening disease is defined as: Radiographic: MRI with a fluid collection >2 cm in 2 of 3 dimensions, edema, inflammation or sign of active inflammatory response. An increased number of tracts may be seen, or increased branching from the primary tract, Clinical: Increased drainage per patient report and on clinical exam
Lack of response
MONTH 12
Number of participants with lack of response post-injection of 75 million allogeneic bone marrow derived MSC's for the treatment of perianal fistula(s) in the setting of Crohn's disease Lack of response is defined as: Radiographic and Clinical healing which does not meet the threshold for Partial Healing
Partial clinical healing
MONTH 12
Number of participants with partial clinical healing post-injection of 75 million allogeneic bone marrow derived MSC's for the treatment of perianal fistula(s) in the setting of Crohn's disease Partial clinical healing is defined as: Radiographic Healing: MRI with an absence of a fluid collection >2 cm in 2 of 3 dimensions, lack of edema, inflammation or sign of active inflammatory response. A remnant scar of a fistula tract may remain Clinical healing: Greater than or equal to 50 % cessation of drainage on both clinical exam with deep palpation and per patient report and epithelization of the external fistula opening
Complete clinical healing
MONTH 12
Number of participants with complete clinical healing post-injection of 75 million allogeneic bone marrow derived MSC's for the treatment of perianal fistula(s) in the setting of Crohn's disease. Complete Healing is defined as: Radiographic Healing: MRI with an absence of a fluid collection >2 cm in 3 of 3 dimensions, lack of edema, inflammation or sign of active inflammatory response. A remnant scar of a fistula tract may remain Clinical Healing: 100% cessation of drainage on both clinical exam with deep palpation and per patient report and epithelization of the external fistula opening

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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