Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 12:12 PM
Study NCT ID:
NCT01157650
Status:
COMPLETED
Last Update Posted:
2016-11-08
First Post:
2010-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Fistulous Crohn's Disease by Implant of Autologous Mesenchymal Stem Cells Derived From Adipose Tissue
Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Organization:
Study Overview
Official Title:
Treatment of Fistulous Crohn's Disease by Implant of Autologous Mesenchymal Stem Cells Derived From Adipose Tissue
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary outcome measure:
Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred during the study.
Secondary outcome measures:
1. Evaluating the Adipose-derived mesenchymal stem cells therapeutic effect, in particular:
* Fistulas healing efficiency
* Changes in quality of life in patients treated
* Changes of systemic Crohn's disease after implant
* Relapse rate monitored among patients who achieved Adipose-derived mesenchymal Stem Cells treatment success.
2. Achieving the biological characterization of the cell product used and its correlation with the therapeutic effect measured with:
* Phenotype study
* Suppressor capacity study.
* Citoquines production analysis
Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred during the study.
Secondary outcome measures:
1. Evaluating the Adipose-derived mesenchymal stem cells therapeutic effect, in particular:
* Fistulas healing efficiency
* Changes in quality of life in patients treated
* Changes of systemic Crohn's disease after implant
* Relapse rate monitored among patients who achieved Adipose-derived mesenchymal Stem Cells treatment success.
2. Achieving the biological characterization of the cell product used and its correlation with the therapeutic effect measured with:
* Phenotype study
* Suppressor capacity study.
* Citoquines production analysis
Detailed Description:
The aim of this study is to evaluate the role of Autologous Mesechymal Stem Cells derived from adipose tissue in the treatment of fistulous Crohn disease.
15 Crohn's disease patients with one or more enterocutaneous, recto-vaginal or complex perianal fistula, will be included.
The trial is divided in three phases:
I. - Selection: Patients evaluation for study eligibility will take place within two weeks after Informed Consent signature.
Fistulous disease will be evaluated by MRI for perianal and rectovaginal fistulas, and by CT scan in the case of enterocutaneous fistula.
Previous laboratory test and radiological studies are valid for evaluation if they were obtained within two and six months, respectively, prior to this evaluation, and in the absence of clinical changes.
II.- Treatment phase includes:
1. Liposuction procedure to obtain adipose tissue.
2. Processing and production of Autologous Mesenchymal Stem Cells from adipose tissue (ASCs)
3. ASCs implant
III.- Follow up: Study visits post-implant will take place at the 1st week (+/- 3 days), 4th week (+/- 3 days), 8th week (+/- 7 days), 12nd week (+/- 7 days), 24th week (+/- 7 days), and 1 year (+/- 7 days) after implant.
15 Crohn's disease patients with one or more enterocutaneous, recto-vaginal or complex perianal fistula, will be included.
The trial is divided in three phases:
I. - Selection: Patients evaluation for study eligibility will take place within two weeks after Informed Consent signature.
Fistulous disease will be evaluated by MRI for perianal and rectovaginal fistulas, and by CT scan in the case of enterocutaneous fistula.
Previous laboratory test and radiological studies are valid for evaluation if they were obtained within two and six months, respectively, prior to this evaluation, and in the absence of clinical changes.
II.- Treatment phase includes:
1. Liposuction procedure to obtain adipose tissue.
2. Processing and production of Autologous Mesenchymal Stem Cells from adipose tissue (ASCs)
3. ASCs implant
III.- Follow up: Study visits post-implant will take place at the 1st week (+/- 3 days), 4th week (+/- 3 days), 8th week (+/- 7 days), 12nd week (+/- 7 days), 24th week (+/- 7 days), and 1 year (+/- 7 days) after implant.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-009880-71 | EUDRACT_NUMBER | None | View |