Ignite Creation Date:
2024-05-06 @ 4:07 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02454231
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2015-05-19
Brief Title:
Monocentric Trial Stem Cell Emergency Life Threatening Limbs Arteriopathy SCELTA
Sponsor:
University of Florence
Organization:
University of Florence
Study Overview
Official Title:
Monocentric Randomized Study for the Therapy of Critic Limb Ischemia With Bone Marrow- or Peripheral Blood-derived Stem Cells
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCELTA
Brief Summary:
The investigators designed a randomized clinical trial stem cell emergency life threatening arteriopathy or SCELTA to compare the therapeutic efficacy of the auto-transplant of enriched circulating EPCs ECEPCs with auto-transplant of BM-MNCs ECEPCs obtained by immunoselection of CD14 and CD34 cells or BM-MNCs were injected intramuscularly in the affected limb of patients with critical limb ischemia CLI
Detailed Description:
Peripheral arterial disease comprises a clinical spectrum that extends from no symptoms to presentation with critical limb ischemia CLI which is a very invalidating condition characterized by rest pain march inability trophic lesions and unavoidable progression to major amputations which are burdened by a high mortality in the first year The pathophysiology of CLI often associates with a defect in the development of collateral vessels and angiogenesis a process which refers to the formation of new blood vessels into tissue due to circulating endothelial progenitor cells EPCs and vascular progenitor cells In the last few years significant improvement of this condition has been reported following bone marrow BM autotransplant or autotransplant of peripheral EPCs mobilized from BM through the injection of granulocyte-colony stimulatory factor G-CSF In a previous study the investigators found that individually variable proportions of circulating CD14 cells expressed low levels of CD34 CD14CD34low and revealed the functional phenotype of EPCs The investigators therefore designed a monocentric randomized clinical trial to compare the therapeutic efficacy of BM autotransplant with the autotransplant of a population of circulating CD34 and CD14CD34low enriched by a closed sterile immunomagnetic system enriched circulating EPCs or ECEPCs without a previous EPC mobilization from BM
Patients will be evaluated for clinical parameters and ABI TBI TCp02 before autotransplant and at three follow-up times after the autotransplant 4 24 and 52 weeks also angio-TAC of legs capillaroscopy and photoplethysmography will be evaluated at 4 and even at 52 weeks
Patients will be evaluated for clinical parameters and ABI TBI TCp02 before autotransplant and at three follow-up times after the autotransplant 4 24 and 52 weeks also angio-TAC of legs capillaroscopy and photoplethysmography will be evaluated at 4 and even at 52 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None