A Prospective, Open, Non-randomized Phase I/II Study of Therapeutic Angiogenesis in Diabetic Patients With Critic Ischemia of Lower Limbs While Administering Positive CD133 Mobilized With G-CSF

April 4, 2014 updated by: PETHEMA Foundation

The primary objective is to analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.

The secondary objectives are:

  • To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.
  • To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs.
  • To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

A total of up to 20 diabetic patients with critic ischemia of lower limbs will be included in the study. Patients will be administered with CD133+ cells, that previously have been obtained of their peripheral blood after mobilization with G-CSF

The study is divided in three phases:

Pre-treatment (previous 4 weeks of CD133+ cells mobilization). Treatment (cells mobilization, CD133+ transplant, 24 hours after infusion visit, 4, 12 and 24 weeks after transplant visits) Follow-up (9 and 12 months after transplant visits)

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca
      • Pamplona, Spain
        • Clinica Universitaria de Navarra
      • Salamanca, Spain
        • Hospital Clínico Universitario
      • Tarragona, Spain
        • Hospital Joan XIII de
      • Valladolid, Spain
        • Hospital Clínico Universitario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • According to the investigator opinion, patient is able to carry out with all the clinical trial requirements
  • Patient must volunteer sign the inform consent before any study specific test, that is not part of the common patient attention, is performed. Patient must know that he/she can abandon the study at any time with no damage to his/her posterior attention
  • Age 18 to 75
  • A diagnosis of chronic critic ischemia of the lower limbs
  • Diabetes Mellitus active
  • III or IV stages (Fontaine classification): resting pain, ulcer or minor gangrene with no major amputation
  • General contraindication or local inoperability or refractory/progression after previous surgical treatment, according to the investigator criteria
  • If female reproductive potential, negative pregnancy test

Exclusion Criteria:

  • Pregnant or currently breast feeding women
  • Acute myocardial infarction within the last 3 years
  • Non re-vascular unstable angina pectoris
  • History of ischemia stroke within the last 3 years
  • Neoplasia at the time of inclusion or Chemotherapy or Radiotherapy treatment in the last 5 years
  • Chronic renal insufficiency
  • G-CSF contraindication
  • A non well controlled serious concomitant disease
  • History of serious thrombotic episodes within the past 3 years
  • Patients who have received other investigational therapy within 30 days previous to the study inclusion
  • Patients currently in other clinical trial or receiving any other investigational agent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CD133+ cells
CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.
Biological: CD133+ cells transplant
intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood
Time Frame: 2 months
2 months
To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs
Time Frame: 12 months
12 months
To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Investigators

  • Study Chair: Mª Consuelo Del Cañizo, Dr, Hospital Clínico de Salamanca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

October 1, 2008

First Submitted That Met QC Criteria

October 1, 2008

First Posted (Estimate)

October 2, 2008

Study Record Updates

Last Update Posted (Estimate)

April 7, 2014

Last Update Submitted That Met QC Criteria

April 4, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-000693-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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