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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01144962
Other study ID # P10.102
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received June 14, 2010
Last updated December 29, 2014
Start date June 2010
Est. completion date December 2014

Study information

Verified date December 2014
Source Leiden University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: Ministry of Health, Welfare and Sport
Study type Interventional

Clinical Trial Summary

In a dose escalation study we will determine the safety and preliminary efficacy of allogeneic bone marrow mesenchymal stem cells (bmMSCs) in the induction of response for active fistulizing Crohn's Disease (CD).


Description:

Despite the introduction of anti-TNFa (tumor necrosis factor alpha) therapy, perianal disease still accounts for a high rate of morbidity in patients diagnosed with CD. Recently, a phase II multicenter randomized study was reported showing that expanded adipose tissue derived mesenchymal stem cells (atMSCs) in combination with fibrin glue was an effective and safe treatment for complex perianal fistula. However, dose escalation of allogeneic bone marrow (bm) MSCs for the local treatment of perianal fistulas has not been studied.

In this study, three escalating doses will be tested in a total of three cohorts. MSC implantation will be preceded by surgical localization, curettage of the fistulous tract and closure of the internal opening. Per cohort, patients will be randomized in a 5:2 fashion to receive either 10x10^6 (cohort 1), 30x10^6 (cohort 2) or 90x10^6 (cohort 3) bmMSCs or no cells (control group).

The primary endpoint will be assessed at week 12: i) the number of adverse and serious adverse events and ii) a reduction in the number of draining fistulas, which is defined as absence of discharge and absence of collections of ≥2 cm directly related to the treated fistulas tracts as measured by MRI.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Localization, curettage of the fistulous tract and closure of the internal opening without MSC injection.
Patients will undergo surgical localization, curettage of the fistulous tract and closure of the internal opening, without injection of MSCs.
Localization, curettage of the fistulous tract and closure of the internal opening with local MSC injection.
Patients will undergo surgical localization, curettage of the fistulous tract and closure of the internal opening, with local injection of indicated dose of MSCs

Locations

Country Name City State
Netherlands Leiden University Medical Center (LUMC) Leiden Zuid Holland

Sponsors (2)

Lead Sponsor Collaborator
Leiden University Medical Center DigestScience

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and efficacy (fistula closure) i) the number of adverse and serious adverse events and ii) a reduction in the number of draining fistulas, which is defined as absence of discharge and absence of collections of =2 cm directly related to the treated fistulas tracts as measured by MRI (Magnetic Resonance Imaging). 12 weeks Yes
Secondary Clinical scores 1. To assess changes in the Crohn's Disease Activity Index (CDAI), the Perianal Disease Activity Index (PDAI) and the adapted Vaizey fecal incontinence score before and after mesenchymal stem cell (MSC) treatment; 12 weeks No
Secondary Endoscopic scores 2. To compare endoscopic changes before and after local bmMSC treatment using the Crohn's Disease Endoscopic Index of Severity (CDEIS) and simplified endoscopic activity score for Crohn's disease (SES-CD); 12 weeks No
Secondary Quality of life 3. To evaluate the effect of local treatment with autologous bmMSCs on the quality of life of patients with fistulizing CD using the short Inflammatory Bowel Disease Questionnaire (sIBDQ) and Short Form (SF)-36 score; 12 weeks No
Secondary C-reactive protein (CRP) 4. To summarize the changes from baseline compared to 12 weeks in serum C-reactive protein (CRP). 12 weeks No
Secondary Safety 5. To assess the incidence of surgical intervention and infections. 12 and 24 weeks Yes
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