Intraarterial Infusion of Autologous Marrow Derived Mononuclear Cells in Diabetic Patients With Chronic Critical Limb Ischemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Fundación Pública Andaluza Progreso y Salud.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT00987363
First received: September 29, 2009
Last updated: August 1, 2011
Last verified: January 2011
  Purpose

The aim of the study is to asses the safety and efficacy of the intraarterial infusion of autologous bone marrow mononuclear cells 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. Sixty patients will be randomly assigned to receive three different doses of marrow mononuclear cells or no intervention. 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
Arterial Occlusive Disease
Diabetic Foot
Other: Intraarterial infusion of autologous bone marrow 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: Phase 1/2 Clinical Trial of Therapeutic Angiogenesis With Autologous Bone Marrow-derived Mononuclear Cells in Diabetic Patients With Chronic Critical Limb Ischemia Without Revascularization Options

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: 24 h, 1,3 ,6 ,9 and 12 months ] [ Designated as safety issue: Yes ]
  • Arteriographic, AngioRNM and AngioTC changes [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinically objective improvement in the ischemic limb [ Time Frame: 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose
The dose of infused cells is 1x10 E8
Other: Intraarterial infusion of autologous bone marrow cells
Autologous bone marrow-derived mononuclear cells will be infused by an intraarterial catheter into de ischemic limb. The number of infused cells will be 1x10 E8, 5x10E8 and 1x10 E9 in the low,intermediate and high dose arms respectively
Experimental: Intermediate dose
The dose of infused cells is 5x10 E8
Other: Intraarterial infusion of autologous bone marrow cells
Autologous bone marrow-derived mononuclear cells will be infused by an intraarterial catheter into de ischemic limb. The number of infused cells will be 1x10 E8, 5x10E8 and 1x10 E9 in the low,intermediate and high dose arms respectively
Experimental: High dose
The dose of infused cells is 1x10 E9
Other: Intraarterial infusion of autologous bone marrow cells
Autologous bone marrow-derived mononuclear cells will be infused by an intraarterial catheter into de ischemic limb. The number of infused cells will be 1x10 E8, 5x10E8 and 1x10 E9 in the low,intermediate and high dose arms respectively
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years to 80 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 (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
  9. Alcoholism
  10. Proliferative retinopathy
  11. HIV, HBV or HCV viral infection
  12. Stroke or myocardial infarction during the last 3 months
  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: NCT00987363

Locations
Spain
Hospital Universitario Reina Sofia
Cordoba, Spain, 14004
Hospital Universitario San Cecilio
Granada, Spain, 18012
Hospital Universitario Morales Meseguer
Murcia, Spain, 30008
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Fondo de Investigacion Sanitaria
Investigators
Study Director: Inmaculada Herrera, MD, PhD Hospital Universitario Reina Sofia
Principal Investigator: Francisco Tadeo Gomez, MD, PhD Hospital Virgen del Rocio
Principal Investigator: Jose Patricio Linares, MD, PhD Hospital Universitario San Cecilio
Principal Investigator: Diego Martinez, MD, PhD Hospital Universitario Morales Messeguer
Principal Investigator: Antonio Chacon, MD, PhD Hospital Universitario Reina Sofia
Principal Investigator: Jose Garcia-Revillo, MD,PhD Hospital Universitario Reina Sofia
Principal Investigator: Miguel Canis, MD Hospital Universitario Reina Sofia
Principal Investigator: Pablo Gonzalez, MD Hospital Universitario San Cecilio
Principal Investigator: Salvador Oyonarte, MD CRTS Granada
Principal Investigator: Eduardo Ros, MD,PhD Hospital Universitario San Cecilio
Principal Investigator: Rafael Ros, MD,PhD Hospital Universitario San Cecilio
Principal Investigator: Magdalena Carmona, MD Hospital Universitario Virgen del Rocio
Principal Investigator: Javier Peiro, MD Hospital Universitario Virgen del Rocio
Principal Investigator: Ricardo Asensio, MD Hospital Universitario San Cecilio
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00987363     History of Changes
Other Study ID Numbers: CMMo/ICPC/2008, EudraCT 2008-004064-39
Study First Received: September 29, 2009
Last Updated: August 1, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundación Pública Andaluza Progreso y Salud:
critical limb ischemia
diabetic foot
bone marrow derived mononuclear cells
cell therapy

Additional relevant MeSH terms:
Ischemia
Diabetic Foot
Arterial Occlusive Diseases
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on September 29, 2014