Status:
COMPLETED
Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients
Lead Sponsor:
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Collaborating Sponsors:
Iniciativa Andaluza en Terapias Avanzadas
Conditions:
Critical Limb Ischemia (CLI)
Diabetes
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose. The study population will consist of 30 non-diabetic patients with critical chronic ischemia in a...
Eligibility Criteria
Inclusion
- Diabetes, type 1 or 2
- Critical Limb Ischemia (Rutherford Becker Class II,III or IV)of at least one limb.
- No options for target limb revascularization.
Exclusion
- Cancer antecedent in the last two years
- Current limb infection or limb gangrene
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01257776
Start Date
December 1 2010
End Date
July 1 2015
Last Update
August 5 2015
Active Locations (2)
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1
University Hospital Virgen Macarena
Seville, Seville, Spain, 41007
2
CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine)
Seville, Seville, Spain, 41092