NCT00400959

Brief Summary

TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction. TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group. SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB) grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al., Circulation, 2002). OBJECTIVES Primary:

  1. 1.To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone marrow (ABM) and mobilized peripheral blood (MPB) in the target population.
  2. 2.To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in the culprit vessel of the target population, on regional and global contractile function and on perfusion and metabolism of the infarcted area, depending on cell dose and comparing to controls.
  3. 3.To evaluate the disease-related morbility of the target population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2004

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

June 1, 2004

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
Last Updated

November 17, 2006

Status Verified

November 1, 2006

First QC Date

November 14, 2006

Last Update Submit

November 15, 2006

Conditions

Acute Myocardial Infarction

Keywords

cell therapyacute myocardial infarction

Outcome Measures

Primary Outcomes (2)

  • myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),

  • Ejection fraction (%) evaluated by 2D echocardiography;

Secondary Outcomes (2)

  • perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG);

  • Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D

Interventions

cd133+cell intracoronary administrationPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Informed consent;
  • age: 18-65 years;
  • large acute myocardial infarction (due to proximal occlusion of the left anterior descending or the right coronary artery) after successful primary PTCA carried out between the IV and the XXIV hour from the onset of AMI symptoms;
  • signs of microvascular dysfunction in the infarcted area: absence of STeR and angiographic MB, graded according to the dye density score (see van't Hof et al., Circulation, 1998); life expectancy more than 6 months.

You may not qualify if:

  • Pregnancy;
  • indication to aorto-coronaric by-pass;
  • neoplasia (previous or in progress);
  • primary diseases of the BM;
  • diabetes;
  • immunosuppressive therapy;
  • laboratory alterations of protein S, protein C, ATIII or Fibrinogen;
  • severe co-morbidity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cell Factory, department of regenerative medicine, Policlinic of Milan

Milan, Italy

Location

Related Publications (1)

  • Colombo A, Castellani M, Piccaluga E, Pusineri E, Palatresi S, Longari V, Canzi C, Sacchi E, Rossi E, Rech R, Gerundini P, Viecca M, Deliliers GL, Rebulla P, Soligo D, Giordano R. Myocardial blood flow and infarct size after CD133+ cell injection in large myocardial infarction with good recanalization and poor reperfusion: results from a randomized controlled trial. J Cardiovasc Med (Hagerstown). 2011 Apr;12(4):239-48. doi: 10.2459/JCM.0b013e328343d708.

    PMID: 21372740DERIVED

Study Officials

  • Rosaria Giordano, MD

    Cell Factory Department of Regenerative Medicine Policlinic Milan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2006

First Posted

November 17, 2006

Study Start

June 1, 2004

Study Completion

October 1, 2006

Last Updated

November 17, 2006

Record last verified: 2006-11

Locations

IT(1)