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Study, Double Blind, Randomized, Comparing Two Groups to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells From Adipose Tissue (CMMAd) in the Treatment of the Faecal Incontinence

NCT02292628 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-04-17

No results posted yet for this study

Summary

This is a clinical trial phase I/II, double blind, randomized to compare in two groups of patients to evaluate the safety and efficacy of the autologous mesenchymal stem cells from the adipose tissue (CMMAd) in the treatment of the faecal incontinence.

Conditions

  • Faecal Incontinence

Interventions

DRUG

Infusion of mesenchymal stem cells from adipose tissue

OTHER

Infusion of placebo

Sponsors & Collaborators

  • Iniciativa Andaluza en Terapias Avanzadas

    collaborator OTHER

  • Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

    lead OTHER

Principal Investigators

  • Fernando de la Portilla, Dr. · Hospital U. Virgen del Rocio

  • Santiago Mera, Dr. · Hospital Regional U de Málaga

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-09-30
Completion
2017-09-30

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 NCT02292628 on ClinicalTrials.gov