drugset
drugset / Trial / NCT02287974

Clinical Trial I/II Opened, Randomized and Controlled for the Study of the Use of Stem Cells Therapy in Insulinized Diabetic Patients Type 2 With Critical Ischemia in Lower Limbs (CLI): Study of the Needs of Insulin

NCT02287974 ↗

Phase 1/2 Terminated 20 enrolled Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud Iniciativa Andaluza en Terapias Avanzadas · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

To study the effect of the stem cells therapy autologous mononuclear from the bone marrow, autologous progenitor endothelial CD133 cells from the bone marrow and autologous mesenchymal stem cells from adipose tissue on the inflammatory cytokines, the resistance to insulin and the decrease of the needs of insulin, besides evaluates the safety, viability and efficiency of the intra-arterial infusion of stem cells in diabetic patients type 2 with CLI.

Timeline

Start
2011-09
Primary completion
2018-07
Completion
2018-07

Outcome

Outcome not reported

Stopped (Enrollment): “Patients' numebr randomized not achieved. Investigators team with lack of interest and commitment. The sponsor closed prematurely patients' recruitment.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous endothelial progenitor CD133 stem cell from the bone marrow Cell therapy 2e+06 cells Other
Subject Autologous endothelial progenitor CD133 stem cell from the bone marrow Cell therapy 7e+06 cells Other
Subject Autologous mesenchymal stem cells from the adipose tissue Cell therapy 500000 cells Other
Subject Autologous mononuclear stem cell from the bone marrow Cell therapy 1.5e+08 cells Other
Subject Autologous mononuclear stem cell from the bone marrow Cell therapy 2.5e+08 cells Other

Indications

limb ischemia