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Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA)

NCT02454231 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-05-09

No results posted yet for this study

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).

Conditions

  • Critical Limb Ischemia

Interventions

BIOLOGICAL

Transplantation of circulating CD14+CD34+cells

intramuscular injection of circulating EPC at leg level

BIOLOGICAL

Transplantation of BM MNC

intramuscular injection of BM MNC at leg level

Sponsors & Collaborators

  • Tuscany Region

    collaborator UNKNOWN

  • University of Florence

    lead OTHER

Principal Investigators

  • Enrico Maggi, professor · University of Florence

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2015-05-31
Completion
2015-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02454231 on ClinicalTrials.gov