drugset / Trial / NCT03968198

Administration of Adipose-derived Stem Cells (ASC) in Patient With Critical Limb Ischemia.

NCT03968198 ↗

NaSingle-groupOpen-labelTreatment

Summary

Different types of stem cells have recently been studied in clinical trial on ischemic disease of the heart and muscular arteries. Adipose derived stem cell, have shown in vitro and in vivo models a stronger potential of success in recovering from ischemic disease and oxygenation of the tissues. The investigators already shown in a phase I study, that adipose derived mesenchymal cells injected in patients with critical limb ischemia and no option for revascularization, had a very good tolerance and interesting effects on skin oxygenation and healing. The aim of the present clinical trial is to confirm the efficacy autologous transplantation of adipose tissue derived mesenchymal cells in patients with critical limb ischemia with poor options or no option for revascularization.

Timeline

Start
2020-03-04
Primary completion
2023-03-10
Completion
2023-03-10

Outcome

Outcome not reported

Stopped: “organizational difficulties for the collection of adipose tissue and for the supply of the experimental drug”

Drugs

EvaluationDrugModalityDoseRoute
Subject Adipose-derived Stem/Stroma Cell Unknown 9e+07 cells Intramuscular

Indications