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Trial record 25 of 78 for:    Recruiting, Not yet recruiting, Available Studies | "Bone Transplantation"

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

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ClinicalTrials.gov Identifier: NCT01874015
Recruitment Status : Recruiting
First Posted : June 10, 2013
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Biological: mesenchymal cell transplantation Biological: mesenchymal cell and fibroblast injection Phase 1

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease
Actual Study Start Date : February 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. fistula closure [ Time Frame: 4months ]
    Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease.


Secondary Outcome Measures :
  1. CDAI [ Time Frame: 4months ]
    Evaluation the decrease of CDAI after mesenchymal cell transplantation.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874015


Contacts
Contact: Nasser Aghdami, MD,PhD +9823562000 ext 504 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD +9823562000 ext 414 Leara91@gmail.com

Locations
Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD         
Principal Investigator: Massoud Vosough, MD,PhD         
Sub-Investigator: vagihe azimian, MSc         
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
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

Additional Information:
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01874015     History of Changes
Other Study ID Numbers: Royan-GI-003
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Royan Institute:
Crohn's disease
mesenchymal stem cell
fistula

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases