Research with human participants

Overview of medical research in the Netherlands

A multi-centre, double-blind, randomised, placebo-controlled trial using CD133 enriched bone marrow cells following primary angioplasty for acute myocardial infarction with central core laboratory analysis.

Published:
Last updated:

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Ethical review
Approved WMO
Status
Will not start
Health condition type
Heart failures
Study type
Interventional

ID

NL-OMON36752

Source

ToetsingOnline

Brief title

SELECT-AMI

Condition

  • Heart failures
  • Cardiac therapeutic procedures

Synonym

heart failure, ischemic cardiomyopathy

Research involving

Human

Sponsors and support

Primary sponsor :
Cardiovascular Center Aalst
Source(s) of monetary or material Support :
wetenschapsgeld deelnemende ziekenhuizen,Miltenyi Biotec

Intervention

Keyword :
Coronary, Myocardial infarction, Stemcell, Transplantation

Outcome measures

Primary outcome

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Secondary outcome

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Background summary

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Study objective

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Study design

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Intervention

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Study burden and risks

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Public
Cardiovascular Center Aalst

Moorselbaan 164
9300 Aalst
Belgie
Scientific
Cardiovascular Center Aalst

Moorselbaan 164
9300 Aalst
Belgie

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

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Exclusion criteria

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Design

Study phase :
2
Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Placebo
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Will not start
Enrollment :
30
Type :
Anticipated

Medical products/devices used

Product type :
Medicine
Generic name :
Somatic cells autologous

Approved WMO
Date :
Application type :
First submission
Review commission :
CCMO: Centrale Commissie Mensgebonden Onderzoek (Den Haag)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2007-001448-33-NL
CCMO NL35051.000.10