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

Phase 1

Completed

• Conditions: Critical Limb Ischemia (CLI); Diabetes
• Interventions: Drug: Autologous adipose derived mesenchymal stem cells

• Registration Number: NCT01257776
• Lead Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

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 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Primary Completion: 2013-02
• Status Verified: 2014-11
• Study Completion: 2015-07
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesenchymal stem cells 0,5 million * weight (kg)	Autologous adipose derived mesenchymal stem cells	Group of low dose of Mesenchymal stem cells.
Mesenchymal stem cells 1 million * weight (kg)	Autologous adipose derived mesenchymal stem cells	Group of mid dose of mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis)	6 months	Target limb vascularization would be quantified by a dedicated software, MetaMorph® v.6.3, by using Angiogenesis Tube Formation application module. Neovasculogenesis would be the difference between vascularization at baseline and 6 months follow-up.
Major adverse event (death, target limb amputation)	1 month, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Ankle Brachial Index	1 month, 6 months, 12 months
University of Texas Classification at target limb	1 month, 6 months, 12 months

Trial Locations

Locations (2)

University Hospital Virgen Macarena; 🇪🇸 Seville, Spain

CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine); 🇪🇸 Seville, Spain