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Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia

NCT04466007 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-04-27

No results posted yet for this study

Summary

Phase II national, multicenter, double-blind, randomized, placebo-controlled, phase-3 clinical trial of 3 parallel groups.

Conditions

  • Limb Ischemia
  • Diabetic Foot

Interventions

DRUG

High dose allogeneic mesenchymal stromal cells

Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly

DRUG

Low dose allogeneic mesenchymal stromal cells

Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly

DRUG

Placebos

0,9% physiological saline

Sponsors & Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra

    collaborator OTHER

  • Hospital Universitario La Paz

    collaborator OTHER

  • Gregorio Marañón Hospital

    collaborator OTHER

  • Hospital Clínico Universitario de Valladolid

    collaborator OTHER

  • Hospital Universitario Virgen de la Arrixaca

    collaborator OTHER

  • University of Salamanca

    collaborator OTHER

  • Hospital General Universitario de Alicante

    collaborator OTHER

  • Hospital Universitario La Fe

    collaborator OTHER

  • Hospital Victoria Eugenia Cruz Roja Española

    collaborator UNKNOWN

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2024-05-27
Completion
2024-12-05

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 NCT04466007 on ClinicalTrials.gov