Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients
NCT ID: NCT01257776
Last Updated: 2015-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
33 participants
INTERVENTIONAL
2010-12-31
2015-07-31
Brief Summary
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The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs (CLI) and without possibility of revascularization, from whom results can clinically be evaluable, of whom, 20 patients will be included in the experimental group (10 for each dose level) and 10 in the control group.
In each of the two dose levels to be used in the study, 15 patients will be included, who will be randomized to the experimental group or the control group according to a distribution 2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level, we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose tissue) and 5 patients in the control group (conventional treatment)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mesenchymal stem cells 0,5 million * weight (kg)
Group of low dose of Mesenchymal stem cells.
Autologous adipose derived mesenchymal stem cells
Intra-arterial administration through a selective cannulation of target common femoral artery
Mesenchymal stem cells 1 million * weight (kg)
Group of mid dose of mesenchymal stem cells
Autologous adipose derived mesenchymal stem cells
Intra-arterial administration through a selective cannulation of target common femoral artery
Controlled group
Controlled group with no intervention
No interventions assigned to this group
Interventions
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Autologous adipose derived mesenchymal stem cells
Intra-arterial administration through a selective cannulation of target common femoral artery
Eligibility Criteria
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Inclusion Criteria
* Critical Limb Ischemia (Rutherford Becker Class II,III or IV)of at least one limb.
* No options for target limb revascularization.
Exclusion Criteria
* Current limb infection or limb gangrene
18 Years
85 Years
ALL
No
Sponsors
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Iniciativa Andaluza en Terapias Avanzadas
OTHER
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
OTHER
Responsible Party
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Principal Investigators
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Rafael J Ruiz-Salmeron, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Virgen Macarena. Seville.Spain
Antonio De la Cuesta, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Virgen Macarena. Seville.Spain
Locations
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University Hospital Virgen Macarena
Seville, Seville, Spain
CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine)
Seville, Seville, Spain
Countries
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Other Identifiers
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CeTMAd/ICPD/2008
Identifier Type: -
Identifier Source: org_study_id
NCT01079403
Identifier Type: -
Identifier Source: nct_alias
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