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

PETHEMA Foundation

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF

Treatments

Biological: CD133+ cells transplant

Study type

Interventional

Funder types

Other

Identifiers

NCT00765050

2008-000693-20

Details and patient eligibility

About

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

Full 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)

Enrollment

13 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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