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AzTrials

Heart FailurePhase 2IMPACT-CABGNCT01467232

IMPACT-CABG Trial: IMPlantation of Autologous CD133+ sTem Cells in Patients Undergoing Coronary Artery Bypass Grafting

A Phase 2 study testing Injection of autologous CD133+ stem cells at the time of coronary artery bypass grafting in people with Heart Failure and Heart Attack, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Following myocardial infarct, cellular therapy is a potential approach to repopulate the injured myocardium, to treat heart failure and restore cardiac function. The purpose of this study is to assess the safety, feasibility and efficacy of intramyocardial delivery of selected autologous CD133+ bone marrow stem cells… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Injection of autologous CD133+ stem cells at the time of coronary artery bypass grafting
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteCanada
Study dates
Sep 2011to Oct 2015
Phase
Phase 2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years, and ≤75 years.
  • Patients with severe chronic ischemic cardiomyopathy manifested by Canadian Cardiovascular Society (CCS) class II or greater angina, and/or New York Heart Association (NYHA) class II or greater dyspnea, AND who have undergone diagnostic coronary angiography demonstrating ≥70% diameter narrowing of at least two major coronary arteries or branches or ≥50% diameter narrowing of the left main coronary artery.
  • Significant left ventricular systolic dysfunction evaluated by echocardiography or LV angiography (LV ejection fraction ≤45% but ≥25%) due to a prior myocardial infarction. This area of left ventricular dysfunction should be akinetic or severely hypokinetic, not dyskinetic or aneurysmal, when assessed by echocardiography or LV angiogram.
  • No contraindications or exclusions (see below).
  • Willingness to participate and ability to provide informed consent.

Who cannot join

  • contraindications to magnetic resonance imaging (MRI) including presence of an implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM), or cases in which it is anticipated that an ICD or PPM will be implanted prior to the 6 month follow-up or claustrophobia (thus precluding performance of follow-up MRI scans).
  • Need for urgent or emergent revascularization.
  • Anticipated for concomitant surgical procedure at the time of CABG (e.g. valve repair or replacement, aneurysm resection, etc.).
  • Hemodynamically unstable patients, as defined by heart rate ≤40/min or ≥100/min, and/or systolic blood pressure <90 mmHg or ≥200 mmHg, and/or ongoing need for intravenous inotropic or vasopressor medications.
  • Patients with confirmed myocardial infarction within 14 days, and/or rising cardiac biomarker proteins (i.e. CK-MB or troponin), and/or worsening ECG changes.
  • Prior CABG surgery.
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  • Stroke within 3 months prior to plan CABG.
  • Immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.)
  • Severe chronic renal insufficiency (serum creatinine ≥ 200 mmol/dl or need for dialysis),liver disease, (diagnosis of cirrhosis, chronic hepatitis, or elevated serum transaminases ≥3 times the upper limit of normal), cerebrovascular disease requiring concomitant carotid endarterectomy, peripheral arterial disease (claudication as the primary factor limiting activity), active non-dermatological malignancy requiring on-going treatment, or any other condition that would place the patient at increased risk for complications during the first 6 months after the procedure in the judgement of the attending cardiologist or cardiac surgeon.
  • Contra-indication to bone marrow aspiration (Thrombocytopenia <50,000 mm3, INR >2.0 ).
  • Hemoglobin less than 10g/dL, white blood cell count less than 4,000/mm3, absolute neutrophil count less than 1500/mm3
  • Active infection, with a temperature greater than 37.5°C within 48 hours prior to surgery and an unexplained white blood cell count in excess of 10,000/mm3
  • Myelodysplastic syndrome
  • Significant cognitive impairment
  • Any condition associated with a life expectancy of less than 6 months
  • Known allergic reaction or contraindication to any of the components of the CD133+ enriched cells
  • Participation in other studies
  • History of severe ventricular tachyarrhythmia's requiring treatment
  • Positive laboratory test results or a history of syphilis, Hepatitis B Virus, Hepatitis C Virus, Human T-Lymphotropic Virus Type 1 and 2, and Human Immunodeficiency Virus.
  • Pregnant woman
  • Inability or unwillingness to provide written informed consent

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Peter Munk Cardiac Center/ University Health Network

    Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Official title: Implantation of Autologous CD133+ Stem Cells in Patients Undergoing CABG

Following myocardial infarct, cellular therapy is a potential approach to repopulate the injured myocardium, to treat heart failure and restore cardiac function. The purpose of this study is to assess the safety, feasibility and efficacy of intramyocardial delivery of selected autologous CD133+ bone marrow stem cells at the time of coronary artery bypass grafting in patients with chronic ischemic cardiomyopathy.

Read the detailed description

CD133+ are well characterized distinct early progenitor group of stem cells that possess high engraftment, pluripotent and angiogenic capacity and proved to be valuable for cardiac repair by promoting neovascularization, inhibition of apoptosis and cardiomyogenesis.

The investigators proposed research protocol involves patients with chronic ischemic heart disease and left ventricular dysfunction undergoing coronary artery bypass grafting (CABG). In this phase II clinical trial, prospective, randomized, 2 arm, double-blind, placebo-controlled study, the investigators will assess the safety, feasibility and functional effect of intra-myocardial injection of highly selected autologous CD133+ bone marrow stem cells to placebo.

Being tested
Injection of autologous CD133+ stem cells at the time of coronary artery bypass grafting
Medical subject headings
Heart Failure, Myocardial Infarction

What participants receive

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

  • Injection of autologous CD133+ stem cells at the time of coronary artery bypass graftingBiological

    Also called Autologous CD133+ stem cells or placebo solution containing autologous plasma without CD133+

    Following completion of the distal coronary artery bypasses, autologous CD133+ stem cells, or placebo (saline solution containing autologous plasma without CD133+) will be injected into the myocardium.

  • Injection of autologous CD133+ stem cells at the time of coronary artery bypass graftingBiological

    Also called Autologous CD133+ stem cells or placebo solution containing autologous plasma without CD133+.

    Following completion of the distal coronary artery bypasses, autologous CD133+ stem cells, or placebo (saline solution containing autologous plasma without CD133+) will be injected into the myocardium

Study groups in NCT01467232
Study groupRoleWhat they receive
Autologous CD133+ Stem CellsExperimentalAutologous CD133+ stem cells
Receives: Biological: Injection of autologous CD133+ stem cells at the time of coronary artery bypass grafting
Saline solution containing autologous plasmaPlacebo comparatorSaline solution containing autologous plasma without CD133+ (indistinguishable from the autologous CD133+ stem cells)
Receives: Biological: Injection of autologous CD133+ stem cells at the time of coronary artery bypass grafting

What is being measured

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

  1. Freedom from Major Adverse Cardiac Event

    cardiac death, myocardial infarct, repeat coronary bypass grafting or percutaneous intervention of bypassed artery.

    Measured: 6 months

  2. Freedom from major arrhythmia

    sustained ventricular tachycardia or survived sudden death.

    Measured: 6 months

Secondary outcomes (5)

  1. Regional myocardial perfusion and function assessed by magnetic resonance scans

    Measured: 6 months

  2. Global ventricular function assessed by echocardiographic measures of ejection fraction

    Measured: 6 months

  3. Relief of symptom severity after CABG surgery

    Measured: 6 months

  4. Device performance end point

    Feasibility to produce from 100ml of bone marrow aspiration a final cell product that contains a target CD133+ cells higher than 0.5 million with a purity superior to 30% and a recovery superior to 10%.

    Measured: baseline

  5. Quality of Life after CABG surgery

    Measured: 6 months

Timeline

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

  1. First posted8 Nov 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionNov 2014
  4. Study completionOct 2015

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01467232
Sponsor's protocol ID
UHN-CCR-002
Acronym
IMPACT-CABG
Status last verified
Nov 2015
First submitted
28 Oct 2011
Last updated
2 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Noiseux N, Mansour S, Weisel R, Stevens LM, Der Sarkissian S, Tsang K, Crean AM, Larose E, Li SH, Wintersperger B, Vu MQ, Prieto I, Li RK, Roy DC, Yau TM. The IMPACT-CABG trial: A multicenter, randomized clinical trial of CD133+ stem cell therapy during coronary artery bypass grafting for ischemic cardiomyopathy. J Thorac Cardiovasc Surg. 2016 Dec;152(6):1582-1588.e2. doi: 10.1016/j.jtcvs.2016.07.067. Epub 2016 Aug 13.

    PubMed 27665225

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Injection of autologous CD133+ stem cells at the time of coronary artery bypass grafting in people with Heart Failure and Heart Attack, run by University Health Network, Toronto at 1 site in Canada.

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 5 inclusion and 21 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: finished, as of the sponsor's last update on 2 Dec 2015. 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 Canada. 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Freedom from Major Adverse Cardiac Event (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT01467232, which also lists 1 linked publication.

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 2 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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