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Dose-escalating Therapeutic Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Fistulas in Patients With Refractory Perianal Crohn's Disease

NCT01144962 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2014-12-30

No results posted yet for this study

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).

Conditions

Interventions

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.

PROCEDURE

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

Sponsors & Collaborators

  • DigestScience

    collaborator UNKNOWN

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Hein W Verspaget, PhD · Leiden University Medical Center (LUMC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01144962 on ClinicalTrials.gov