MedTrace Logo

Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells for the Induction of Remission in Ulcerative Colitis

NCT01914887 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2013-08-02

No results posted yet for this study

Summary

The aims of our study are to evaluate the feasibility and safety of endoscopic injection of adipose tissue-derived mesenchymal stem cells in human subjects with moderate active ulcerative colitis, assessing the absence of adverse events associated to the investigational drug, and to evaluate the efficacy of the treatment to induce remission of moderate active ulcerative colitis, by improvements in disease activity index, quality of life index, and endoscopic index.

Conditions

Interventions

DRUG

Allogeneic adipose tissue-derived mesenchymal stem cells

The cells will be given in different sites within the affected colonic submucosa at a total dose of 60 million cells with the use of a colonoscope.

Sponsors & Collaborators

  • Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

    collaborator OTHER

  • Ministry of Health, Spain

    collaborator OTHER_GOV

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Maria Dolores Martin Arranz, MD · Gastroenterology Department

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT01914887 on ClinicalTrials.gov