Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetes; Critical Limb Ischemia (CLI)

Treatments: Drug: Autologous adipose derived mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01257776

CeTMAd/ICPD/2008

Details and patient eligibility

About

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 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)

Enrollment: 33 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Cancer antecedent in the last two years
• Current limb infection or limb gangrene

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

Mesenchymal stem cells 0,5 million * weight (kg)

Active Comparator group

Description:

Group of low dose of Mesenchymal stem cells.

Treatment:

Drug: Autologous adipose derived mesenchymal stem cells

Mesenchymal stem cells 1 million * weight (kg)

Active Comparator group

Description:

Group of mid dose of mesenchymal stem cells

Treatment:

Drug: Autologous adipose derived mesenchymal stem cells

Controlled group

No Intervention group

Description:

Controlled group with no intervention