CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
High dose allogeneic mesenchymal stromal cells +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04466007
NCT04466007Phase 2Completed
CompareCT.gov

Multicenter, Randomized, Dose-search, Parallel, Double-blind, and Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Intramuscular Administration of Allogeneic Adipose Tissue Adult Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia Without Possibility of Revascularization

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz·interventional·Posted Jul 10, 2020·Updated Apr 27, 2025

In Brief

A Phase 2 clinical trial evaluating High dose allogeneic mesenchymal stromal cells, Low dose allogeneic mesenchymal stromal cells, and 1 other intervention for Limb Ischemia and Diabetic Foot. Completed, enrolled 90 participants across 10 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLimb Ischemia, Diabetic Foot
CountriesSpain
CollaboratorsClinica Universidad de Navarra, Universidad de Navarra, Hospital Universitario La Paz, Gregorio Marañón Hospital, Hospital Clínico Universitario de Valladolid, Hospital Universitario Virgen de la Arrixaca, University of Salamanca, Hospital General Universitario de Alicante, Hospital Universitario La Fe, Hospital Victoria Eugenia Cruz Roja Española

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJul 10, 2020
Enrollment StartJan 11, 2021
Primary CompletionMay 27, 2024
Study CompletionDec 5, 2024
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.0 years ago

Interventions

High dose allogeneic mesenchymal stromal cellsdrug

Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly

Low dose allogeneic mesenchymal stromal cellsdrug

Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly

Placebosdrug

0,9% physiological saline