drugset / Trial / NCT00765050

A Prospective, Open, Non-randomized Phase I/II Study of Therapeutic Angiogenesis in Diabetic Patients With Critic Ischemia of Lower Limbs While Administering Positive CD133 Mobilized With G-CSF

NCT00765050 ↗

Phase 1/2 Terminated 13 enrolled PETHEMA Foundation
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective is to analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs. The secondary objectives are: * To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood. * To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs. * To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients

Timeline

Start
2009-01
Primary completion
2012-10
Completion
2012-10

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject CD133+ cells Unknown — Intramuscular

Indications

No indication recorded.