NCT04466007

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Disease or disorder under study: Critical ischemia of the lower limbs in diabetic patients without the possibility of revascularization. Main valuation variable: Proportion of Adverse Events related to treatment.

Conditions

• Limb Ischemia
• Diabetic Foot

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-11
• Primary completion: 2024-05-27
• Completion: 2024-12-05
• First posted: 2020-07-10
• Last updated: 2025-04-27

Locations

10 sites across 1 country: Spain