Nonrevascularizable Critical Ischemia of the Lower Limbs Clinical Trial
— HULPVASOfficial 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
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | September 2015 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: 1. Informed Consent. 2. > 18 years. 3. Chronic arterial ischemia grades IV-V of Rutherford that affects at least one limb. 4. Arterial occlusion direct flow or distal femoropopliteal level. 5. No option for surgical or endovascular revascularization. 6. Life expectancy exceeding two years. 7. High probability of need for major amputation at 6 months (CLI nonrevascularizable). 8. Negative pregnancy test if applicable. Exclusion Criteria: 1. Background of hematologic neoplasia or unresolved. 2. Hipertensión uncontrolled blood (> 180/110). 3. Severe heart Insuficiencia (New York Heart Association [NYHA] IV) or ejection fraction <30%. 4. Malignant ventricular, Arritmias. 5. Trombosis of deep vein the past three months. 6. active infection. 7. Infarto infarction or stroke the previous three months. 8. Medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study. 9. Subjects with congenital or acquired immunodeficiencies. Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion, treponema. 10. Major surgery or severe trauma of the subject in the previous semester. 11. Administration of any investigational drug at present to three months prior to enrollment for this trial. 12. Pulmonary heart disease, in the opinion of the investigator, be unstable or is sufficiently serious to dismiss the patient from the study. 13. Infants or pregnant women. 14. Adult women of childbearing potential not using effective contraception during the trial |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario La Paz | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto de Investigación Hospital Universitario La Paz | Hospital Universitario La Paz |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Clinical evaluation of patients after treatment | Clinical evaluation of patients after treatment with magnetic resonance angiography, tissue oximetry records and ankle-brachial index. | One year | No |
| Primary | Safety of inject mesenchymal stem cells in MMII | 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. | one year | Yes |
| Secondary | Quality of life of patients after treatment | We analyze the quality of life of patients by SF-12 test | one year | No |