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Treatment of Fistulous Crohn's Disease by Implant of Autologous Mesenchymal Stem Cells Derived From Adipose Tissue

NCT01157650 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-11-08

No results posted yet for this study

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

Conditions

  • Crohn Disease

Interventions

OTHER

Autologous mesenchymal stem cells

The trial is divided in three phases: I. - Selection: Patients evaluation for study eligibility will take place within two weeks after Informed Consent signature. 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.

Sponsors & Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Principal Investigators

  • Felipe Prosper, MD, PhD · Clinica Universidad de Navarra

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01157650 on ClinicalTrials.gov