Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease

April 26, 2017 updated by: Royan Institute

Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease

This study is a prospective, randomized, parallel, phase 1 trial to assess the safety and feasibility of the transplantation of bone marrow derived mesenchymal stem cells (MSCs) in fistulizing Crohn's disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study all eligible patients were randomly allocated into two study groups by a permuted block randomization method: group A receives only autologous MSCs suspended in fibrin glue, group B receives autologous MSCs+ Fibroblasts. Both groups receive 4 injections inside the wall and lumen of the fistula. Injections will be repeated every month.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Royan Institute
        • Contact:
          • Nasser Aghdami, MD,PhD
        • Principal Investigator:
          • Massoud Vosough, MD,PhD
        • Sub-Investigator:
          • vagihe azimian, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1- Poor response to routine treatments in refractory Crohn's disease with fistula.

    2- CDAI>220 3- Age 18 to 60 years 4- GFR>30, Cr<2 5- The presence of perinea fistula.

Exclusion Criteria:

  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mesenchymal cell and fibroblast transplantaion
The patients with crohn's disease who underwent mesenchymal cell and fibroblast injection.
Biological: mesenchymal cell and fibroblast injection
Transplantation of mesenchymal cell and fibroblast in patients with crohn's disease.
Active Comparator: mesenchymal cell transplantaion
The patients with Crohn's disease who underwent mesenchymal cell transplantation.
Biological: mesenchymal cell transplantation
Mesenchymal cell transplantation in patients with Crohn's disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fistula closure
Time Frame: 4months
Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease.
4months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDAI
Time Frame: 4months
Evaluation the decrease of CDAI after mesenchymal cell transplantation.
4months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Investigators

  • Study Director: Nasser Aghdami, MD,PhD, Head of Royan department of degenerative medicine,Head of Royan celltherapy center
  • Study Director: Mahdi Mohammad Nejhad, MD, TUMS DDRI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

June 6, 2013

First Submitted That Met QC Criteria

June 7, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-GI-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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