NCT01595776

Brief Summary

Aim: to value the safety and efficacy of local intramuscular administration of immunoselected autologous endothelial progenitor cells in the treatment of critical limb ischemia in patients without revascularization options. Primary goal: to value the feasibility of mobilization, harvesting, immunoselection and auto transplantation of endothelial progenitor cells. Secondary goal: to value the efficacy of local administration of autologous endothelial progenitor cells in the treatment of critical limb ischemia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

2.9 years

First QC Date

February 14, 2012

Last Update Submit

June 13, 2012

Conditions

Critical Limb Ischemia

Keywords

CLI, PAD, Buerger disease

Outcome Measures

Primary Outcomes (1)

  • Contrast enhanced ultrasound (CEUS)

    Muscular and arterial ultrasound before and after endovenous injection of contrast medium (SonoVue BR1; Bracco, Milan, Italy)

    3-6-12 months

Secondary Outcomes (2)

  • Pain relief

    3-6-12 months

  • ulcer healing

    3-6-12 months

Study Arms (1)

single arm: autologous EPCs

EXPERIMENTAL
Other: Endothelial progenitor cells intramuscular implant

Interventions

Endothelial progenitor cells intramuscular implantOTHER

After marrow stimulation the CD133+ cell count was monitored daily. Each leukapheresis collection was diluted with 10% acide citrate dextrose (ACD-A)CD133 immunomagnetic cell selections were performed . After loco-regional anesthesia and below the knee cutaneous disinfection, 45-48 ml of autologous CD133+ saline solution suspension is administered intramuscularly with 1 ml deep injection through 18G needle. The injections were so allocated: 10 ml in the anterior compartment of leg, 10 ml in the superficial posterior compartment, 10 ml in the deep posterior compartment, 10 ml in the lateral compartment and the remaining part in the foot.

Also known as: Cell therapy in critical limb ischemia.
single arm: autologous EPCs

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • written informed consent
  • critical limb ischemia (TASC 2 criteria)
  • No surgical nor endovascular options

You may not qualify if:

  • clinical instability
  • extensive gangrene
  • every serious systemic disease
  • life expectancy \< 24 months
  • previous similar studies
  • previous experimental drug studies within 3 months
  • allergy
  • child bearing age
  • conflict of interest in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (2)

  • Arici V, Bozzani A, Ragni F, Perotti C, Del Fante C, Calliada F, Pagani M, Odero A, Autologous endothelial progenitor cells derived from peripheral blood for the treatment of critical limb ischemia in no-option patients: pilot study, Ital J Vas Endovasc Surg 2010; 17(3) Suppl 1: 11-4

    RESULT

  • Arici V, Perotti C, Fabrizio C, Del Fante C, Ragni F, Alessandrino F, Viarengo G, Pagani M, Moia A, Tinelli C, Bozzani A. Autologous immuno magnetically selected CD133+ stem cells in the treatment of no-option critical limb ischemia: clinical and contrast enhanced ultrasound assessed results in eight patients. J Transl Med. 2015 Nov 3;13:342. doi: 10.1186/s12967-015-0697-4.

    PMID: 26526721DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening IschemiaThromboangiitis Obliterans

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemiaVasculitis

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Attilio Odero, Professor

    Department of Vascular Surgery - Fondazione IRCCS Policlinico S. Matteo, Pavia - Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2012

First Posted

May 10, 2012

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

IT(1)