A Phase 1 interventional study of mesenchymal cell transplantation and mesenchymal cell and fibroblast injection in Crohn's Disease, sponsored by Royan Institute. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-27.
Sponsored by Royan Institute · Phase 1, Interventional, and Treatment
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.
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 10 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Royan Institute is the lead sponsor of 92 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
The patients with crohn's disease who underwent mesenchymal cell and fibroblast injection.
Biological: mesenchymal cell and fibroblast injection
The patients with Crohn's disease who underwent mesenchymal cell transplantation.
Biological: mesenchymal cell transplantation
Mesenchymal cell transplantation in patients with Crohn's disease.
Transplantation of mesenchymal cell and fibroblast in patients with crohn's disease.
fistula closure
Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease.
Time frame: 4months
CDAI
Evaluation the decrease of CDAI after mesenchymal cell transplantation.
Time frame: 4months
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Royan Institute