Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF Clinical Trial
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
| Verified date | April 2014 |
| Source | PETHEMA Foundation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Ministry of Health |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 13 |
| Est. completion date | October 2012 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Virgen de la Arrixaca | Murcia | |
| Spain | Clínica Universitaria de Navarra | Pamplona | |
| Spain | Hospital Clínico Universitario | Salamanca | |
| Spain | Hospital Joan XIII de | Tarragona | |
| Spain | Hospital Clínico Universitario | Valladolid |
| Lead Sponsor | Collaborator |
|---|---|
| PETHEMA Foundation |
Spain,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes | |
| Secondary | To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood | 2 months | Yes | |
| Secondary | 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 | No | |
| Secondary | To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients | 12 months | No |