The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Administration will be preceded by localization and closure of the internal opening. Cell treatment injection will be performed following Major Ambulatory Surgery standards. Patients will receive an intralesional dose of 20 million cells at baseline. 50% of the cell suspension will be placed into fistula walls of the internal opening, with the remaining 50% being injected across the wall tracts of the target fistula. Patients without healing (complete fistula closure)at week 12 will receive a second dose of 40 million cells, using the same treatment approach.
Hospital Universitario La Paz
Madrid, Madrid, Spain
Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed
Time frame: 12 weeks
Quality of life assessment using the SF-36 questionnaire
Time frame: 12 weeks
Adverse events
Time frame: 1, 4, 8,12, 24, 54 weeks
Clinically relevant variations in laboratory test
Time frame: 1, 4 8, 12, 24, 54 weeks
Quality of life assessment using the SF-36 questionnaire
Time frame: 24 weeks
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