Clinical trial NCT01824069: Treatment CLI Nonrevascularizable Lower Limb With Cell Therapy
Official title: Phase IIa Clinical Trial to Safety of Treatment in Critical Ischemia Nonrevascularizable Lower Limb by Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nonrevascularizable Critical Ischemia of the Lower Limbs
Keywords: Critical Ischemia
Amputation
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Paz
First posted: 2013-04-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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

Eligibility 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.

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

Primary outcomes:
measure: Safety of inject mesenchymal stem cells in MMII
timeFrame: one year
Secondary outcomes:
measure: Quality of life of patients after treatment
timeFrame: one year
Other outcomes:
measure: Clinical evaluation of patients after treatment
timeFrame: One year
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Instituto de Investigación Hospital Universitario La Paz
name: Luis Riera del Moral, Doctor
role: PRINCIPAL_INVESTIGATOR
References: