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NCT Number: NCT01257776

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

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Key information

Conditions

Critical Limb Ischemia (CLI) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Diabetes Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Ischemia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous adipose derived mesenchymal stem cells

Drug

Intra-arterial administration through a selective cannulation of target common femoral artery

Primary outcomes

  1. 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.

  2. Major adverse event (death, target limb amputation)

    Time frame: 1 month, 6 months, 12 months

Secondary outcomes

  1. Ankle Brachial Index

    Time frame: 1 month, 6 months, 12 months

  2. University of Texas Classification at target limb

    Time frame: 1 month, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Iniciativa Andaluza en Terapias Avanzadas

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Dec 10, 2010
Registry last updated
Aug 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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