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
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
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD133+ cells | Unknown | — | Intramuscular |
Indications
No indication recorded.