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

Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients

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)

Study Overview

• Status: Completed
• Conditions: Diabetes; Critical Limb Ischemia (CLI)
• Intervention / Treatment: Drug: Autologous adipose derived mesenchymal stem cells

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41007
    • University Hospital Virgen Macarena
  • Seville, Spain, 41092
    • CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mesenchymal stem cells 0,5 million * weight (kg); Group of low dose of Mesenchymal stem cells.	Drug: Autologous adipose derived mesenchymal stem cells; Intra-arterial administration through a selective cannulation of target common femoral artery
Active Comparator: Mesenchymal stem cells 1 million * weight (kg); Group of mid dose of mesenchymal stem cells	Drug: Autologous adipose derived mesenchymal stem cells; Intra-arterial administration through a selective cannulation of target common femoral artery
No Intervention: Controlled group; Controlled group with no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis)	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.	6 months
Major adverse event (death, target limb amputation)		1 month, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Ankle Brachial Index	1 month, 6 months, 12 months
University of Texas Classification at target limb	1 month, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Collaborators: Iniciativa Andaluza en Terapias Avanzadas
• Investigators: Principal Investigator: Rafael J Ruiz-Salmeron, MD, PhD, University Hospital Virgen Macarena. Seville.Spain; Principal Investigator: Antonio De la Cuesta, MD, University Hospital Virgen Macarena. Seville.Spain

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: December 9, 2010
• First Submitted That Met QC Criteria: December 9, 2010
• First Posted (Estimate): December 10, 2010

Study Record Updates

• Last Update Posted (Estimate): August 5, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Diabetes; Mesenchymal Stem Cells; Critical Limb Ischemia (CLI); Regenerative Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: CeTMAd/ICPD/2008