Crohn's DiseasePhase 1NCT01874015
Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease
A Phase 1 study testing mesenchymal cell transplantation and mesenchymal cell and fibroblast injection in people with Crohn's Disease, run by Royan Institute at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- mesenchymal cell transplantation and mesenchymal cell and fibroblast injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- Feb 2013to Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Royan Institute
Tehran
Nasser Aghdami, MD,PhD
Massoud Vosough, MD,PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- mesenchymal cell transplantation, mesenchymal cell and fibroblast injection
- Keywords
- Crohn's disease, mesenchymal stem cell, fistula
- Medical subject headings
- Crohn Disease, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal cell transplantationBiological
Mesenchymal cell transplantation in patients with Crohn's disease.
mesenchymal cell and fibroblast injectionBiological
Transplantation of mesenchymal cell and fibroblast in patients with crohn's disease.
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal cell and fibroblast transplantaion | Active comparator | The patients with crohn's disease who underwent mesenchymal cell and fibroblast injection. Receives: Biological: mesenchymal cell and fibroblast injection |
| mesenchymal cell transplantaion | Active comparator | The patients with Crohn's disease who underwent mesenchymal cell transplantation. Receives: Biological: mesenchymal cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
fistula closure
Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease.
Measured: 4months
Secondary outcomes (1)
CDAI
Evaluation the decrease of CDAI after mesenchymal cell transplantation.
Measured: 4months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteNasser Aghdami, MD,PhD, Study director, Head of Royan department of degenerative medicine,Head of Royan celltherapy centerMahdi Mohammad Nejhad, MD, Study director, TUMS DDRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874015
- Sponsor's protocol ID
- Royan-GI-003
- Status last verified
- Apr 2017
- First submitted
- 6 Jun 2013
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease
- ClinicalTrials.gov ID
- NCT01874015
- Acronym / sponsor ID
- Royan-GI-003
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, mesenchymal stem cell, fistula
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesenchymal cell and fibroblast transplantaion | Active comparator | Biological: mesenchymal cell and fibroblast injectionThe patients with crohn's disease who underwent mesenchymal cell and fibroblast injection. |
| mesenchymal cell transplantaion | Active comparator | Biological: mesenchymal cell transplantationThe patients with Crohn's disease who underwent mesenchymal cell transplantation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesenchymal cell transplantationMesenchymal cell transplantation in patients with Crohn's disease. | Biological | mesenchymal cell transplantaion |
| mesenchymal cell and fibroblast injectionTransplantation of mesenchymal cell and fibroblast in patients with crohn's disease. | Biological | mesenchymal cell and fibroblast transplantaion |
Primary outcome
fistula closure
Time frame: 4months
Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease.
1 secondary outcome
CDAI
Time frame: 4months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Related InfoLink provided by the sponsor.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Nasser Aghdami, MD,PhD study director
Head of Royan department of degenerative medicine,Head of Royan celltherapy center
Mahdi Mohammad Nejhad, MD study director
TUMS DDRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mesenchymal cell transplantation and mesenchymal cell and fibroblast injection in people with Crohn's Disease, run by Royan Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasser Aghdami, MD,PhD (+9823562000 ext. 504, nasser.aghdami@royaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fistula closure (time frame: 4months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.