Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2013
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 6, 2013
CompletedFirst Posted
Study publicly available on registry
June 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedApril 27, 2017
April 1, 2017
4.8 years
June 6, 2013
April 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
fistula closure
Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease.
4months
Secondary Outcomes (1)
CDAI
4months
Study Arms (2)
mesenchymal cell and fibroblast transplantaion
ACTIVE COMPARATORThe patients with crohn's disease who underwent mesenchymal cell and fibroblast injection.
mesenchymal cell transplantaion
ACTIVE COMPARATORThe patients with Crohn's disease who underwent mesenchymal cell transplantation.
Interventions
Mesenchymal cell transplantation in patients with Crohn's disease.
Transplantation of mesenchymal cell and fibroblast in patients with crohn's disease.
Eligibility Criteria
You may qualify if:
- Poor response to routine treatments in refractory Crohn's disease with fistula.
- CDAI\>220 3- Age 18 to 60 years 4- GFR\>30, Cr\<2 5- The presence of perinea fistula.
You may not qualify if:
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Royan Institute
Tehran, Iran
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2013
First Posted
June 10, 2013
Study Start
February 1, 2013
Primary Completion
December 1, 2017
Study Completion
February 1, 2018
Last Updated
April 27, 2017
Record last verified: 2017-04