Clinical trial NCT00765050: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF
Keywords: Cellular therapy
CD133+
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.
timeFrame: 12 months
Secondary outcomes:
measure: To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood
timeFrame: 2 months
measure: To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs
timeFrame: 12 months
measure: To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients
timeFrame: 12 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario
city: Tarragona
country: Spain
facility: Hospital Joan XIII de
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario
Study officials:
affiliation: Hospital Clínico de Salamanca
name: Mª Consuelo Del Cañizo, Dr
role: STUDY_CHAIR
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