drugset / Trial / NCT01456819

Intramuscular Mononuclear Cells and Mesenchymal Stem Cells Transplantation to Treat Chronic Critical Limb Ischemia

NCT01456819

RandomizedParallel-groupSingle-blindTreatment

Summary

This is a randomized and single blinded study aimed to compare the efficacy between intramuscular autologous bone marrow mononuclear cells plus mesenchymal stem cell implantation and intramuscular autologous bone marrow mononuclear cells implantation only in patients with chronic critical limb ischemia. Patients will be randomized into two groups of equal number; patients in one group will be implanted with mononuclear cells and mesenchymal stem cells, and the other implanted with mononuclear cells only in the area of affected limb.

Timeline

Start
2011-03
Primary completion
2015-12
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mononuclear cells Cell therapy Intramuscular
Subject mesenchymal stem cells Cell therapy Intramuscular

Indications