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

Phase 1

Terminated

• Conditions: Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF
• Interventions: Biological: CD133+ cells transplant

• Registration Number: NCT00765050
• Lead Sponsor: PETHEMA Foundation

Brief Summary

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

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 Timeline

• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Study Start: 2009-01
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD133+ cells	CD133+ cells transplant	CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood	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	12 months
To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients	12 months

Trial Locations

Locations (4)

Hospital Joan XIII de; 🇪🇸 Tarragona, Spain

Hospital Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Clínica Universitaria de Navarra; 🇪🇸 Pamplona, Spain

Hospital Clínico Universitario; 🇪🇸 Valladolid, Spain