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

August 4, 2015 updated by: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 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.
6 months
Major adverse event (death, target limb amputation)
Time Frame: 1 month, 6 months, 12 months
1 month, 6 months, 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CeTMAd/ICPD/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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