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

This study has been completed.

Sponsor:

Collaborator:

Iniciativa Andaluza en Terapias Avanzadas

Information provided by (Responsible Party):

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

ClinicalTrials.gov Identifier:

NCT01257776

First received: December 9, 2010

Last updated: August 4, 2015

Last verified: November 2014

History of Changes

Purpose

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)

Condition	Intervention	Phase
Critical Limb Ischemia (CLI) Diabetes	Drug: Autologous adipose derived mesenchymal stem cells	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients

Further study details as provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:

Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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) [ Time Frame: 1 month, 6 months, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Ankle Brachial Index [ Time Frame: 1 month, 6 months, 12 months ] [ Designated as safety issue: No ]
University of Texas Classification at target limb [ Time Frame: 1 month, 6 months, 12 months ] [ Designated as safety issue: Yes ]


Enrollment:	33
Study Start Date:	December 2010
Study Completion Date:	July 2015
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257776

Locations


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

Sponsors and Collaborators

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

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

More Information


Responsible Party:	Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:	NCT01257776 History of Changes
Obsolete Identifiers:	NCT01079403
Other Study ID Numbers:	CeTMAd/ICPD/2008
Study First Received:	December 9, 2010
Last Updated:	August 4, 2015
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:


Critical Limb Ischemia (CLI) Diabetes Mesenchymal Stem Cells Regenerative Therapy

Additional relevant MeSH terms:


Ischemia Pathologic Processes

ClinicalTrials.gov processed this record on September 23, 2016

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