Status:
COMPLETED
Treatment CLI Nonrevascularizable Lower Limb With Cell Therapy
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Collaborating Sponsors:
Hospital Universitario La Paz
Conditions:
Nonrevascularizable Critical Ischemia of the Lower Limbs
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 stu...
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 a...
Eligibility Criteria
Inclusion
- Informed Consent.
- \> 18 years.
- Chronic arterial ischemia grades IV-V of Rutherford that affects at least one limb.
- Arterial occlusion direct flow or distal femoropopliteal level.
- No option for surgical or endovascular revascularization.
- Life expectancy exceeding two years.
- High probability of need for major amputation at 6 months (CLI nonrevascularizable).
- Negative pregnancy test if applicable.
Exclusion
- Background of hematologic neoplasia or unresolved.
- Hipertensión uncontrolled blood (\> 180/110).
- Severe heart Insuficiencia (New York Heart Association \[NYHA\] IV) or ejection fraction \<30%.
- Malignant ventricular, Arritmias.
- Trombosis of deep vein the past three months.
- active infection.
- Infarto infarction or stroke the previous three months.
- Medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study.
- Subjects with congenital or acquired immunodeficiencies. Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion, treponema.
- Major surgery or severe trauma of the subject in the previous semester.
- Administration of any investigational drug at present to three months prior to enrollment for this trial.
- Pulmonary heart disease, in the opinion of the investigator, be unstable or is sufficiently serious to dismiss the patient from the study.
- Infants or pregnant women.
- Adult women of childbearing potential not using effective contraception during the trial
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01824069
Start Date
April 1 2013
End Date
September 1 2015
Last Update
June 15 2016
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046