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

This study has been terminated.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00765050
First received: October 1, 2008
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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

Condition Intervention Phase
Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF
Biological: CD133+ cells transplant
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: January 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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)

  Eligibility

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

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
  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: NCT00765050

Locations
Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Clínica Universitaria de Navarra
Pamplona, Spain
Hospital Clínico Universitario
Salamanca, Spain
Hospital Joan XIII de
Tarragona, Spain
Hospital Clínico Universitario
Valladolid, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: Mª Consuelo Del Cañizo, Dr Hospital Clínico de Salamanca
  More Information

Additional Information:
Publications:

Responsible Party: PETHEMA Foundation, PETHEMA
ClinicalTrials.gov Identifier: NCT00765050     History of Changes
Other Study ID Numbers: 2008-000693-20
Study First Received: October 1, 2008
Last Updated: April 4, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Cellular therapy
CD133+

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014