Back to resultsA 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
Primary Purpose
Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF
Status
Terminated
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
CD133+ cells transplant
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF focused on measuring Cellular therapy, CD133+
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
Sites / Locations
- Hospital Virgen de la Arrixaca
- Clínica Universitaria de Navarra
- Hospital Clínico Universitario
- Hospital Joan XIII de
- Hospital Clínico Universitario
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD133+ cells
Arm Description
CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.
Outcomes
Primary Outcome Measures
analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.
Secondary Outcome Measures
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 Information
1. Study Identification
Unique Protocol Identification Number
NCT00765050
Brief 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
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
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
PETHEMA Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF
Keywords
Cellular therapy, CD133+
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CD133+ cells
Arm Type
Experimental
Arm Description
CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.
Intervention Type
Biological
Intervention Name(s)
CD133+ cells transplant
Intervention Description
intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.
Primary Outcome Measure Information:
Title
analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood
Time Frame
2 months
Title
To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs
Time Frame
12 months
Title
To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mª Consuelo Del Cañizo, Dr
Organizational Affiliation
Hospital Clínico de Salamanca
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital Clínico Universitario
City
Salamanca
Country
Spain
Facility Name
Hospital Joan XIII de
City
Tarragona
Country
Spain
Facility Name
Hospital Clínico Universitario
City
Valladolid
Country
Spain
12. IPD Sharing Statement
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Links:
URL
http://www.aehh.org
Description
Spanish association of Haematology
Learn more about this trial
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
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