NL-OMON36386
Completed
Not Applicable
Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Fistulas in Patients with Refractory Perianal Crohn*s Disease - allo bmMSCs CD fistula
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- fistula
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 21
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) Men and women of at least 18 years of age;
- •b) Patient must have had CD (for at least 3 months from the time of initial diagnosis). The diagnosis of CD must have been confirmed by endoscopic and histologic evidence;
- •c) CDAI score of \<250 at screening and baseline;
- •d) Peri\-anal fistulas must be refractory to conventional medical therapy. Which means that at some time during the course of the disease, patient must have received both steroids and immunosuppressive agents (for example, azathioprine, 6\-mercaptopurine, methotrexate, or infliximab) which did not result in an adequate response to treatment;
- •e) Patients with previous surgical attempts to eradicate perianal fistulas are eligible for inclusion as are patients with setons in situ. Setons will be removed during the surgical procedure
- •f) Patients included in the study might be receiving 5\-aminosalicylic acid (5\-ASA), steroids, azathioprine, 6\-mercaptopurine (6\-MP), methotrexate, infliximab or any similar drug at the time of enrolment, provided the following conditions are fulfilled at screening:
- •The dose of 5\-ASA (both oral and rectal) must have been stable for at least 4 weeks prior to enrolment.
- •The dose of steroids must be stable for at least 4 weeks prior to enrolment.
- •The dose of immunosuppressants (for example azathioprine, 6MP, or methotrexate) must have been stable for at least 8 weeks prior to enrolment and the patient on therapy for at least three months prior to enrolment.
- •The dose of infliximab or other anti\-TNF drug must have been stable for at least 8 weeks prior to enrolment;
Exclusion Criteria
- •a) Patients with evidence of acute peri\-anal infection, presence of peri\-anal abscesses larger than 2 cm, and anal or rectal stricture;
- •b) Patients with evidence of any infections needing antibiotic treatment.
- •c) Rectovaginal fistulas, or complex peri\-anal fistulas with more than two internal openings;
- •d) Patients suffering from renal\- or hepatic failure.
- •e) Use of any investigational drug within 1 month prior to screening or within 5 half\-lives of the investigational agent, whichever is longer;
- •f) Patient is allergic to gadolinium (MRI contrast agent);
- •g) Patient with severe renal insufficiency defined as patients with a glomerular filtration rate (GFR) below 60 mL/min/1\.73 m2\. GFR \= 186\.3 x (serum creatinine)\-1\.154 x (age in years)\-0\.203 x 1\.212 (if patient is black) x 0\.742 (if female);
- •h) Due to the high strength electromagnetic fields that will be used during MRI there is a risk of interference with any metallic implants in the body. The following conditions will disqualify patients from having an MRI and will be excluded from this study:
- •\* electronically, magnetically, and mechanically activated implants
- •\* ferromagnetic or electronically operated stapedial implants
Outcomes
Primary Outcomes
Not specified
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