Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF
Conditions
Keywords
Cellular therapy, CD133+
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)
Interventions
BIOLOGICALCD133+ cells transplant
intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.
Sponsors
PETHEMA Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Spain
Outcome results
None listed