Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization

NCT00987363 | Completed Phase 1 DMC

• 2 other identifiers: CMMo/ICPD/20082008-004064-39
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

The aim of the study is to evaluate the safety and feasibility of autologous bone marrow mononuclear cells autologous administered intra-arterially in the affected limb of diabetic patients with chronic critical ischemia of the lower limbs (CLI) without possibility of revascularization or other therapeutic alternatives. The trial hypothesis we propose consists of mononuclear cells of bone marrow providing progenitor cells with regenerative capacity and secrete also several angiogenic factors, and their implantation into ischemic tissues with both elements should contribute to angiogenesis and tissue regeneration with recovery of the circulation in the affected limb

Conditions

Critical Limb Ischemia (CLI); Diabetic Foot

Keywords

critical limb ischemia (CLI); diabetic foot; bone marrow derived mononuclear cells; cell therapy

Outcome Measures

Primary Outcomes (2)

• Number of adverse events

  24 h, 1,3 ,6 ,9 and 12 months

• AngioRNM and/or AngioTC changes

  baseline and 12 months

Secondary Outcomes (1)

• Clinically objective improvement in the ischemic limb

  1, 3, 6, 9 and 12 months

Study Arms (4)

Low dose (1x10 E8)

EXPERIMENTAL

Dose of 1x10 E8 autologous bone marrow-derived mononuclear cells

Other: Intraarterial infusion of autologous bone marrow cells

Intermediate dose (5x10 E8)

EXPERIMENTAL

Dose of 5x10 E8 autologous bone marrow-derived mononuclear cells

Other: Intraarterial infusion of autologous bone marrow cells

High dose (1x10 E9)

EXPERIMENTAL

Dose of 1x10 E9 autologous bone marrow-derived mononuclear cells

Other: Intraarterial infusion of autologous bone marrow cells

Control

NO INTERVENTION

Conventional treatment established by the good clinical practice

Interventions

Intraarterial infusion of autologous bone marrow cells OTHER

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

High dose (1x10 E9); Intermediate dose (5x10 E8); Low dose (1x10 E8)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or 2 diabetes mellitus
• Grade II-III Rutherford-Becker peripheral vascular disease affecting at least one limb
• Arterial obstruction(s) located at infrapopliteal level
• No options of endoarterial or surgical revascularization
• Life expectancy more than 2 years
• Unlikelihood of major amputation of the leg during the next 12 months
• 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
• Written informed consent
• Negative pregnancy test when applicable

You may not qualify if:

• History of neoplasm or hematological disease
• Uncontrolled high blood pressure (\>180/110)
• Severe cardiac insufficiency (NYHA IV) or ejection fraction\<30%
• Malignant ventricular arrythmia
• Deep venous thrombosis during the last 3 months
• Active bacterial infection
• Treatment with hyperbaric oxygen, vasoactive drugs, Cox-II inhibitors or antiangiogenic agents
• Body mass index \> 40
• Alcoholism
• Proliferative retinopathy
• HIV, HBV or HCV viral infection
• Stroke or myocardial infarction during the last 3 months

Sponsors & Collaborators

• Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud: lead
• Iniciativa Andaluza en Terapias Avanzadas: collaborator

Study Sites (5)

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario San Cecilio

Granada, 18012, Spain

Location

Hospital Universitario Virgen de la Nieves

Granada, 18014, Spain

Location

Hospital Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Diabetic Foot

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Diabetic Angiopathies; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Inmaculada Herrera, MD, PhD

  Hospital Universitario Reina Sofia de Cordoba

  STUDY CHAIR

• 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

• Vicente García, MD,PhD

  University Hospital Virgen de las Nieves

  PRINCIPAL INVESTIGATOR

• Antonio Chacon, MD, PhD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 16, 2016

Record last verified: 2014-11

Locations

ES (5)