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Intraarterial Infusion of Autologous Mesenchymal Stem Cells From Adipose Tissue in Diabetic Patients With Chronic Critical Limb Ischemia (CeTMAd/ICPD200)
This study is currently recruiting participants.
Verified September 2010 by Fundacion Progreso y Salud, Spain

First Received on March 2, 2010.   Last Updated on September 13, 2010   History of Changes
Sponsor: Fundacion Progreso y Salud, Spain
Collaborator: Carlos III Health Institute
Information provided by: Fundacion Progreso y Salud, Spain
ClinicalTrials.gov Identifier: NCT01079403
  Purpose

The Purpose of this trial is to evaluate the safety and feasibility of regenerative therapy with intraarterial infusion of mesenchymal stem cells from adipose tissue, in diabetic patients with chronic critical limb ischemia without revascularization options.

The investigators hypothesize that this approach can be safe and can induce neoangiogenesis in the ischemic limb. During one year follow-up, clinical, angiologic and angiographic measures will be monitored to asses the impact of the cell infusion on the evolution of the ischemic limb.


Condition Intervention Phase
Diabetes
Limb Ischemia
 Other: Autologous mesenchymal stem cells from adipose tissue.
 Phase I
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/2 Clinical Trial of Regenerative Cell Therapy With Autologous Mesenchymal Stem Cells From Adipose Tissue in Diabetic Patients With Chronic Critical Ischemic Syndrome of Lower Limbs

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus
MedlinePlus related topics: Endocrine Diseases Foot Health
U.S. FDA Resources

Further study details as provided by Fundacion Progreso y Salud, Spain:

Primary Outcome Measures:
  • Safety assessment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Number of adverse events

  • Angiography changes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Angiographic evaluation of angiogenesis and vasculogenesis at target limb.

  • Magnetic resonance angiography changes. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Magnetic resonance angiography evaluation of angiogenesis and vasculogenesis at target limb.


Secondary Outcome Measures:
  • Clinical Outcome [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Clinically objective improvement in the ischemic limb.

  • Clinical Outcome [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Ankle-Brachial pressure index


Estimated Enrollment: 36
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose
Intraarterial infusion of autologous mesenchymal stem cells from adipose tissue. Low dose: 0.5x10e6 / Kg.
 Other: Autologous mesenchymal stem cells from adipose tissue.
Intraarterial administration at femoral artery level. Infusion during 3-5 minutes. Low dose: 0.5x10e6 / Kg.
Experimental: Medium dose
Intraarterial infusion of autologous mesenchymal stem cells from adipose tissue. Medium dose: 1 x10e6 / Kg.
 Other: Autologous mesenchymal stem cells from adipose tissue.
Intraarterial administration at femoral artery level. Infusion during 3-5 minutes.Medium dose: 1 x 10e6 / Kg.
Experimental: High dose
Intraarterial infusion of autologous mesenchymal stem cells from adipose tissue. High dose: 2 x 10e6 / Kg.
 Other: Autologous mesenchymal stem cells from adipose tissue.
Intraarterial administration at femoral artery level. Infusion during 3-5 minutes. High dose: 2 x10e6 / Kg.
No Intervention: Control.
Conventional treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 1 or 2 diabetes mellitus
  2. Grade II-III Rutherford-Becker peripheral vascular disease affecting at least one limb
  3. Arterial obstruction(s) located at infrapopliteal level
  4. No options of endoarterial or surgical revascularization
  5. Life expectancy more than 2 years
  6. Unlikelihood of major amputation of the leg during the next 12 months
  7. Normal analytical parameters in blood: leucocytes>3000/micoL, neutrophils>1500 microL, Hb>10mg/dl, platelets>100000 microL,AST and ALT<2.5 standard value, creatinin<2.5 mg/dl
  8. Written informed consent
  9. Negative pregnancy test when applicable

Exclusion Criteria:

  1. History of neoplasm or hematological disease
  2. Uncontrolled high blood pressure (>180/110)
  3. Severe cardiac insufficiency (New York Heart Association [NYHA] IV) or ejection fraction<30%
  4. Malignant ventricular arrythmia
  5. Deep venous thrombosis during the last 3 months
  6. Active bacterial infection
  7. Treatment with hyperbaric oxygen, vasoactive drugs, Cox-II inhibitors or antiangiogenic agents
  8. Body mass index > 40 Kg/m2
  9. Proliferative retinopathy
  10. HIV, Hepatitis B (HBV) or Hepatitis C (HCV) viral infection
  11. Stroke or myocardial infarction during the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079403

Contacts
Contact: Ana Cardesa 0034 955 01 90 40

Locations
Spain
Hospital Universitario Virgen Macarena. Recruiting
Sevilla, Spain, 41007
Contact: Rafael J Ruiz-Salmerón, MD, PhD     0034 955 00 85 88        
Contact: Antonio de la Cuesta, MD     0034 954 55 74 00        
Sponsors and Collaborators
Fundacion Progreso y Salud, Spain
Carlos III Health Institute
Investigators
Principal Investigator: Rafael J Ruiz-Salmeron, MD, PhD. Head of Endovascular Unit. Hospital Universitario Virgen Macarena, Sevilla, Spain.
Principal Investigator: Antonio de la Cuesta, MD Critical Limb Ischemia Unit. Hospital Universitario Virgen Macarena and Hospital San Lazaro, Sevilla, Spain.
  More Information

Additional Information:
Andalusian Initiative for Advanced Therapies  This link exits the ClinicalTrials.gov site
Andalusian Molecular Biology and Regenerative Medicine Centre  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Juan Jesús Bandera, Managing Director., Fundacion Progreso y Salud, Spain
ClinicalTrials.gov Identifier: NCT01079403     History of Changes
Other Study ID Numbers: EudraCT: 2008- 001837- 88
Study First Received: March 2, 2010
Last Updated: September 13, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundacion Progreso y Salud, Spain:
Arterial Occlusive Diseases
Foot Ulcer
Diabetic Neuropathies
Skin Diseases
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Ischemia
 Diabetic Angiopathies
Pathologic Processes
Cardiovascular Diseases
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer
Diabetic patients with Chronic Critical limb ischemia without revascularization options

Additional relevant MeSH terms:
Diabetes Mellitus
Ischemia
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012



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