Treatment of critical limb ischemia non-revascularization by mesenchymal stem cells.
Conditions
Interventions
Product Name: Expanded Mesenchymal Stem Cells autologous derived from lipoaspirated
Product Code: ASC
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Expanded mesenchymal stem cells a
Sponsors
Fundación para la Investigación Biomédica del Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.ArritmiasMalignant ventricular 5. Venous deep Trombosis the past three months. 6.Active infection. 7.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 or treponema at the time of inclusion. 10. Major surgery or severe trauma of the subject in the previous semester. 11. Administration of any investigational drug current or three months prior to enrollment for this trial. 12. Cardiopulmonary disease that in the investigator's opinion, be unstable or is sufficiently serious to rule the patient's study. 13. Infants and pregnant women 14. Adult women of childbearing potential not using contraception effective during the test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Experimental Drug Safety intramuscular use;Secondary Objective: Analyze the limb salvage rate to a year after surgery. Improved arterial vascularization by the ABI tissue oximetry, MRA Quality of life test Pain scale;Primary end point(s): Feasibility and safety of the study will be made once the patient has received treatment at 6 and 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 clinical adverse events during follow-up will be collected at the same times that clinical evaluation. The main objective will be assessed the cumulative incidence of adverse effects attributed to the study therapy.;Timepoint(s) of evaluation of this end point: 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of life of patients and clinical evaluation of the treatment. Test validated generic quality of life (SF-12) and a specific vascular pathology (VASCUQOL), a magnetic resonance angiography records, tissue oximetry and ankle-brachial index.;Timepoint(s) of evaluation of this end point: 6 and 12 months | — |
Countries
Spain
Contacts
Public ContactCell Therapy Unit
Fundación para la Investigación Biomédica del Hospital Universitario La Paz
Outcome results
None listed