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
NCT ID: NCT00765050
Last Updated: 2014-04-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
13 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-01-31
Study Completion Date
2012-10-31
Brief Summary
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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
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
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Detailed Description
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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)
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)
Conditions
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Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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CD133+ cells
CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.
Group Type
EXPERIMENTAL
CD133+ cells transplant
Intervention Type
BIOLOGICAL
intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.
Interventions
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CD133+ cells transplant
intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.
Intervention Type
BIOLOGICAL
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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PETHEMA Foundation
OTHER
Sponsor Role
lead
Responsible Party
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PETHEMA
Principal Investigators
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Mª Consuelo Del Cañizo, Dr
Role: STUDY_CHAIR
Hospital Clínico de Salamanca
Locations
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Hospital Virgen de la Arrixaca
Murcia, , Spain
Site Status
Clínica Universitaria de Navarra
Pamplona, , Spain
Site Status
Hospital Clínico Universitario
Salamanca, , Spain
Site Status
Hospital Joan XIII de
Tarragona, , Spain
Site Status
Hospital Clínico Universitario
Valladolid, , Spain
Site Status
Countries
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Spain
References
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Related Links
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http://www.aehh.org
Spanish association of Haematology
Other Identifiers
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2008-000693-20
Identifier Type: -
Identifier Source: org_study_id
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