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Acute Myocardial InfarctionPhase 2/3EMRTCCNCT00350766

Cell Therapy in Myocardial Infarction

A Phase 2/3 study testing Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation in people with Acute Myocardial Infarction, run by Ministry of Health, Brazil at 1 site in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine cell therapy efficacy in patients with ST elevation acute myocardial infarction (STEMI) Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
166 participants
Where
1 siteBrazil
Study dates
1 Jul 2006to 14 Jul 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients will be eligible if presenting all characteristics described below:
  • ST segment elevation myocardial infarction in two or more contiguous leads, and according to the WHO definition, at least one of the following two:
  • Presence of chest pain. ii) Elevation of the myonecrosis markers.
  • Age between 30 and 80 years old.
  • Ejection fraction ≤50% on Echocardiogram (Simpson) and segmentary dysfunction of the infarction area, measured between the 3rd and 5th day post AMI.
  • Among patients submitted to thrombolytic therapy, the angioplasty of the related artery should be preferably done up to 24h after thrombolysis, with a maximum deadline of 72h after thrombolysis.

Who cannot join

  • Patients will be ineligible if presenting any of the characteristics described below:
  • AMI related artery presenting TIMI < 3 at the moment f cell injection.
  • Left Main Coronary Artery Lesion of >50% or multivessel coronariopathy (>70% lesion in vessels with >2,0mm diameter in left anterior descending, circumflex and right coronary territory) indicating the need for CABG or angioplasty with three or more stents implant.
  • Coronary anatomy, after thrombolytic reperfusion, presenting no need for angioplasty with stent implant.
  • Final Diastolic Pression of the LV higher than 30 mmHg during ventriculography for evaluating EF inclusion criteria for the research protocol (item "c" of inclusion criteria).
  • Cardiac arrest or Killip IV AMI at admission with need of ventilatory support.
Show all 22Show fewer
  • Cardiogenic shock persisting up to the third day after AMI (with need of Intra-aortic balloon pump or vasopressors).
  • AMI mechanical complications (ventricular septal defect, papillary muscle rupture, and left ventricular free wall rupture).
  • Significant valve disease, defined as aortic stenosis (mean systolic pressure gradient across the aortic valve >50mmHg), mitral stenosis with a valvar area less than 1,5 cm,2 moderate to severe aortic and/or mitral regurgitation.
  • Chronic use of immunosuppressive agents.
  • > 2,0 mg/dl creatinine or previous dialysis treatment.
  • Presence of fever on the past 48h before injection glaring active systemic infection according to ACCP/SCCM (American College of Chest Physicians/Society of Critical Care Medicine) sepsis definition.
  • Sustained ventricular tachycardia 48h after AMI.
  • Illicit drugs abuse or alcohol abuse (based on DSM IV).
  • Any co morbidity, with survival impact in two years.
  • Myocarditis
  • Active liver disease
  • COPD in continuous steroids use.
  • Hematological disease, neoplasm, bone disease or hemostatic disturbances.
  • Inflammatory disease or chronicle infectious disease.
  • Presence of definitive implantation of a cardiac pace maker or cardiac defibrillator.
  • Impossibility to reach a cells suspension of 100 million mononuclear cells due to cells paucity in the bone marrow aspirate.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • PROCEP/Hospital Pró-Cardíaco

    Rio de Janeiro, Rio de Janeiro, 22280-000

Other trials in Brazil

About this study

Official title: Multicenter Prospective Randomized Double Blind Trial of Bone Marrow Mononuclear Cells Transplantation Through Intracoronary Injection in Patients With Acute Myocardial Infarction.

The purpose of this study is to determine cell therapy efficacy in patients with ST elevation acute myocardial infarction (STEMI)

Read the detailed description

This study protocol describes a randomized double blind clinical trial, which main purpose is to evaluate the effect of the autologous bone marrow mononuclear cell (ABMMC) implant in 300 Brazilian patients with ST elevation acute myocardial infarction (STEMI).

Double blind study design was chosen for this trial, based on several phase I and II safety trials of intracoronary autologous bone marrow stem cells transplantation, already published. The study coordinator committee, supported by the Brazilian Health Ministry, therefore has proposed a phase III trial with the purpose of proving the efficacy of this kind of therapy, for a population with a high risk of developing heart failure and of death by cardiovascular cause.

Thus, in this protocol we propose a prospective, double blind, controlled and randomized trial to evaluate the effect of ABMMC transplantation through intracoronary infusion, on systolic left ventricle (LV) function. The main hypothesis of this trial is that patients submitted to autologous bone marrow stem cell implant, after 6 months follow up, will present a 5% relative increase of the ejection fraction (EF) comparing to control group.

Being tested
Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation
Keywords
Myocardial Infarction, Myocardial Ischemia, Ventricular Remodeling, Bone Marrow Cell Transplantation, Stem cells
Medical subject headings
Myocardial Infarction, Myocardial Ischemia, Ventricular Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Bone Marrow Mononuclear Cells (ABMMC) TransplantationProcedure or surgery

    Also called Catheter based stem cell delivery

    Catheter based stem cells delivery of 100 million cells resuspended in a 10 ml solution of saline with autologous serum. About 100 ml of Bone Marrow aspirate were harvested from iliac crest between the fifth and seventh day after myocardial infarction. ABMMC were isolated by density gradient centrifugation on Ficoll-PaqueTM plus (Amersham Biosciences) and manipulated under aseptic conditions for injection, after being filtered through 100 um nylon mesh to remove cell aggregates.

Study groups in NCT00350766
Study groupRoleWhat they receive
Treated GroupExperimentalIntracoronary injection in the infarcted-related artery of 100 million bone marrow mononuclear cells resuspended in a 10 ml solution of saline with autologous serum.
Receives: Procedure: Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation
Control GroupPlacebo comparatorIntracoronary injection in the infarcted-related artery of placebo solution consisting of a saline containing autologous blood serum.
Receives: Procedure: Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global Left Ventricular Ejection Fraction change

    Measured: 6 months

Secondary outcomes (7)

  1. Death

    Measured: 30 days, 90 days, 6 months and 1 year

  2. Acute myocardial infarction, stroke and hospital admission due to cardiovascular cause

    Measured: 30 days, 90 days, 6 months and 1 year

  3. Reintervention of the AMI related artery and of the non-related artery

    Measured: 30 days, 90 days, 6 months and 1 year

  4. Regional wall motion, wall thickening, and volume of late contrast enhancement

    Measured: Baseline and 6 months

  5. Evolutive alterations of the coronarian anatomy, as well as the patency of the coronary stents

    Measured: 6 months

  6. Quality of life assessment using the Short-Form 36, Minnesota Living with Heart Failure Questionnaire and Seattle Angina questionnaire

    Measured: Baseline, 6 months and 1 year

  7. Cost-effectiveness and cost-utility evaluation of autologous bone marrow mononuclear cells implant versus conventional treatment

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2006 (estimated)
  2. Study start1 Jul 2006
  3. Primary completion21 Jan 2014
  4. Study completion14 Jul 2014

Why it stopped: Slow recruitment rate and consequent financial exhaustion.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double Blind Randomized Controlled Trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00350766
Sponsor's protocol ID
EMRTCC-IAM
Acronym
EMRTCC
Status last verified
Mar 2017
First submitted
10 Jul 2006
Last updated
30 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Dohmann HF, Silva SA, Sousa AL, Braga AM, Branco RV, Haddad AF, Oliveira MA, Moreira RC, Tuche FA, Peixoto CM, Tura BR, Borojevic R, Ribeiro JP, Nicolau JC, Nobrega AC, Carvalho AC. Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction - MiHeart/AMI study. Trials. 2008 Jul 3;9:41. doi: 10.1186/1745-6215-9-41.

    PubMed 18598362

  • Tura BR, Martino HF, Gowdak LH, dos Santos RR, Dohmann HF, Krieger JE, Feitosa G, Vilas-Boas F, Oliveira SA, Silva SA, Bozza AZ, Borojevic R, de Carvalho AC. Multicenter randomized trial of cell therapy in cardiopathies - MiHeart Study. Trials. 2007 Jan 18;8:2. doi: 10.1186/1745-6215-8-2.

    PubMed 17233910

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation in people with Acute Myocardial Infarction, run by Ministry of Health, Brazil at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow recruitment rate and consequent financial exhaustion.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Left Ventricular Ejection Fraction change (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00350766, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.

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