Back to resultsTransplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
mesenchymal cell transplantation
mesenchymal cell and fibroblast injection
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, mesenchymal stem cell, fistula
Eligibility 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
Sites / Locations
- Royan InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
mesenchymal cell and fibroblast transplantaion
mesenchymal cell transplantaion
Arm Description
The patients with crohn's disease who underwent mesenchymal cell and fibroblast injection.
The patients with Crohn's disease who underwent mesenchymal cell transplantation.
Outcomes
Primary Outcome Measures
fistula closure
Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease.
Secondary Outcome Measures
CDAI
Evaluation the decrease of CDAI after mesenchymal cell transplantation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01874015
Brief Title
Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease
Official Title
Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, mesenchymal stem cell, fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mesenchymal cell and fibroblast transplantaion
Arm Type
Active Comparator
Arm Description
The patients with crohn's disease who underwent mesenchymal cell and fibroblast injection.
Arm Title
mesenchymal cell transplantaion
Arm Type
Active Comparator
Arm Description
The patients with Crohn's disease who underwent mesenchymal cell transplantation.
Intervention Type
Biological
Intervention Name(s)
mesenchymal cell transplantation
Intervention Description
Mesenchymal cell transplantation in patients with Crohn's disease.
Intervention Type
Biological
Intervention Name(s)
mesenchymal cell and fibroblast injection
Intervention Description
Transplantation of mesenchymal cell and fibroblast in patients with crohn's disease.
Primary Outcome Measure Information:
Title
fistula closure
Description
Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease.
Time Frame
4months
Secondary Outcome Measure Information:
Title
CDAI
Description
Evaluation the decrease of CDAI after mesenchymal cell transplantation.
Time Frame
4months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nasser Aghdami, MD,PhD
Phone
+9823562000
Ext
504
Email
nasser.aghdami@royaninstitute.org
First Name & Middle Initial & Last Name or Official Title & Degree
Leila Arab, MD
Phone
+9823562000
Ext
414
Email
Leara91@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Organizational Affiliation
Head of Royan department of degenerative medicine,Head of Royan celltherapy center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mahdi Mohammad Nejhad, MD
Organizational Affiliation
TUMS DDRI
Official's Role
Study Director
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
First Name & Middle Initial & Last Name & Degree
Massoud Vosough, MD,PhD
First Name & Middle Initial & Last Name & Degree
vagihe azimian, MSc
12. IPD Sharing Statement
Links:
URL
http://Royaninstitute.org
Description
Related Info
Learn more about this trial
Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease
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