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Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Non-diabetic Patients With Critical Limb Ischemia (CLI).

NCT01408381 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-03-16

No results posted yet for this study

Summary

Phase II Clinical Trial, a prospective, multicenter, open, randomized, parallel-group controlled with three levels of dose.

The hypothesis of the test we propose is that the mononuclear cells of bone marrow provide progenitor cells with regenerative capacity and besides secrete several angiogenic factors, and their implantation into ischemic tissues with both elements should contribute to angiogenesis and tissue regeneration with recovery of the circulation in the affected limb.

Conditions

  • Critical Limb Ischemia (CLI)

Interventions

OTHER

Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells

Autologous bone marrow-derived mononuclear cells will be infused by an intraarterial catheter into de ischemic limb. The number of infused cells will be 1x108, 5x108 and 1x109 low, intermediate and high dose in the arms respectively.

Sponsors & Collaborators

  • Iniciativa Andaluza en Terapias Avanzadas

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Inmaculada Herrera, MD, PhD · University Hospital Reina Sofía, Córdoba.

  • Antonio Chacon, MD, PhD · University Hospital Reina Sofia, Córdoba

  • Diego Martinez, MD, PhD · University Hospital Morales Meseguer, Murcia

  • Jose P Linares, MD, PhD · University Hospital San Cecilio, Granada

  • Vicente Garcia, MD, PhD · University Hospital Virgen de las Nieves, Granada

  • Andres Garcia, MD, PhD · University Hospital Nuestra Señora de Valme, Sevilla

  • Manuel Piñero, MD, PhD · University Hospital Puerta del Mar, Cádiz

  • Fernando Calleja, MD, PhD · University Hospital Carlos Haya, Málaga

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

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 NCT01408381 on ClinicalTrials.gov