Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI) (SCAMI)

June 7, 2014 updated by: Jochen Wohrle, University of Ulm

Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)

Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo. The study includes an integrated pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size will be calculated. The primary endpoint is the improvement in left ventricular ejection fraction with an assumed 2.5% higher improvement in the cell treated population compared to the placebo treated group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. Patients will be stratified according to age, localization of myocardial infarction and left ventricular function.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89081
        • University of Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • acute myocardial infarction with time to revascularization >6 hours from symptom start
  • clear target vessel
  • large myocardial infarction defined as: proximal vessel occlusion, CK > 1000 U/L, myocardial scar in magnetic resonance imaging > 10% of left ventricular muscle mass
  • potential prior thrombolysis
  • written informed consent

Exclusion Criteria:

  • acute myocardial infarction with revascularization within 6 hours after symptom start
  • prior myocardial infarction
  • no clear target vessel
  • contraindication for magnetic resonance imaging (e.g. pacemaker, ICD)
  • severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging)
  • prior hematologic disease
  • prior chemo therapy
  • prior stem cell transplantation
  • prior treatment with G-CSF
  • known alteration of the bone marrow by alcohol or drugs, e.g. agranulocytosis
  • local infection of puncture sites

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
autologous stem cells, Ficoll preparation, intracoronary administration at the same day of bone marrow cell aspiration
Other: autologous stem cells
intracoronary administration at the same day of cell aspiration using the stop flow technique
Placebo Comparator: 2
placebo is visually indistinguishable from verum due to integration of autologous erythrocytes, intracoronary administration the same day of bone marrow aspiration
Other: placebo suspension
intracoronary administration at the same day as cell aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
left ventricular ejection fraction measured by magnetic resonance imaging
Time Frame: 1, 3, 12 months
1, 3, 12 months
left ventricular enddiastolic volume measured by magnetic resonance imaging
Time Frame: 1, 3, 6, 12 months
1, 3, 6, 12 months
left ventricular endsystolic volume measured by magnetic resonance imaging
Time Frame: 1, 3, 6, 12 months
1, 3, 6, 12 months
major adverse cardiac events
Time Frame: 1, 3, 6, 12 months
1, 3, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Investigators

  • Principal Investigator: Jochen Wöhrle, MD; FESC, University of Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

April 28, 2008

First Submitted That Met QC Criteria

April 29, 2008

First Posted (Estimate)

April 30, 2008

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 7, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCAMI 01-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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