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Treatment CLI Nonrevascularizable Lower Limb With Cell Therapy

NCT01824069 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-06-15

No results posted yet for this study

Summary

It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells derived from lipoaspirate for treating various pathologies fistula. With this project we will address a study population with critical ischemia of lower limbs without possibility of revascularization, either by technical criteria (no intervention possible to compensate for the lack of irrigation of a limb) criteria or risk / benefit (intolerable surgical risk for the type of intervention required). It will almost always elderly patients with multiple comorbidities and high surgical risk who have a lower limb ischemia in critical degree, with very high probability of major amputation in the short term or immediate.

Hypothesis: mesenchymal stem cells obtained by lipoaspirate expanded "ex vivo", are capable of promoting angiogenesis de novo to improve critical limb ischemia lower nonrevascularizable a safe manner

Conditions

  • Nonrevascularizable Critical Ischemia of the Lower Limbs

Interventions

OTHER

Intramuscular injection of a suspension of adult mesenchymal stem cells derived

Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight. Only one dosis by patients

Sponsors & Collaborators

  • Hospital Universitario La Paz

    collaborator OTHER

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Luis Riera del Moral, Doctor · Instituto de Investigación Hospital Universitario La Paz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-04-30
Completion
2015-09-30

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 NCT01824069 on ClinicalTrials.gov