Nonrevascularizable Critical Ischemia of the Lower Limbs Clinical Trial
Official title:
Phase IIa Clinical Trial to Safety of Treatment in Critical Ischemia Nonrevascularizable Lower Limb by Mesenchymal Stem Cells
It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells
derived from lipoaspirate for treating various pathologies fistula. With this project we
will address a study population with critical ischemia of lower limbs without possibility of
revascularization, either by technical criteria (no intervention possible to compensate for
the lack of irrigation of a limb) criteria or risk / benefit (intolerable surgical risk for
the type of intervention required). It will almost always elderly patients with multiple
comorbidities and high surgical risk who have a lower limb ischemia in critical degree, with
very high probability of major amputation in the short term or immediate.
Hypothesis: mesenchymal stem cells obtained by lipoaspirate expanded "ex vivo", are capable
of promoting angiogenesis de novo to improve critical limb ischemia lower
nonrevascularizable a safe manner
The primary endpoint of safety and feasibility study will be done when the patient has
received treatment at 12 months after implantation. It defines that the process is safe when
in the development and monitoring of the trial there has been no adverse events that may be
related to the proposed therapy in the trial. All adverse events will be collected during
the same time monitoring the clinical evaluation. The main objective will be assessed the
cumulative incidence of adverse effects attributed to the study therapy.
Secondary endpoints: As part of the evaluation of the quality of life of patients and
clinical evaluation of the treatment will be at 6, 9 and 12 months after implantation a Test
SF-12, a magnetic resonance angiography, and tissue oximetry records ankle-brachial index
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment