Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease (PFCD)
Perianal Crohn Disease, Perianal Fistula, Crohn Disease
About this trial
This is an interventional treatment trial for Perianal Crohn Disease focused on measuring perianal fistula, perianal Crohn's disease, mesenchymal stromal cells, mesenchymal stem cells
Eligibility Criteria
Inclusion Criteria
- Men and Women 18-75 years of age with a diagnosis of Crohn's disease for at least six months duration.
- Single and Multi-tract Perianal fistula, with or without previous failed surgical repair.
- Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
- Ability to comply with protocol
- Competent and able to provide written informed consent
- Concurrent Crohn's-related therapies with stable doses (>2 months) corticosteroids, 5- ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin therapies are permitted
Exclusion Criteria
- Inability to give informed consent.
- Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the subject.
Specific exclusions:
- Hepatitis B or C
- HIV
- Abnormal AST or ALT at screening(defined as >/= 2x ULN)
- History of cancer including melanoma (with the exception of localized skin cancers) within one year of screening.
- History of colorectal cancer within 5 years
- Investigational drug within one month of treatment
- Pregnant or breast feeding or trying to become pregnant.
- Presence of a rectovaginal or perineal body fistula
- Change in Crohn's immunosuppressive regimen within the 2 months prior to enrollment
- Uncontrolled intestinal Crohn's disease which will require escalation for medical therapy or surgery within 2 months of enrollment
- Severe anal canal disease that is stenotic and requires dilation
- Female participant unwilling to agree to use acceptable contraception methods during participation in study
Sites / Locations
- Cleveland ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Mesenchymal Stem Cells
Placebo
Direct injection of adult allogeneic bone marrow derived mesenchymal stem cells, at a dose of 75 million cells into perianal fistula(s) at baseline with a possible repeat injection at 3 months if not completely healed from the first injection.
Direct injection of normal saline. If not completely healed after 6 months, participants will then cross over to the treatment group to receive a direct injection of adult allogeneic bone marrow derived mesenchymal stem cells, at a dose of 75 million cells into perianal fistula(s)