IMPACT-CABG Trial: IMPlantation of Autologous CD133+ sTem Cells in Patients Undergoing CABG

NCT01033617 | Completed

• 1 other identifier: HD08.147
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 at time of coronary artery bypass grafting in patients with chronic ischemic cardiomyopathy.

Conditions

Myocardial Infarct; Heart Failure

Keywords

Stem cells; Cellular therapy; Myocardial repair

Outcome Measures

Primary Outcomes (2)

• Freedom from Major Adverse Cardiac Event: cardiac death, myocardial infarct, repeat coronary bypass grafting or percutaneous intervention of bypassed artery.

  6 months

• Freedom from major arrhythmia: sustained ventricular tachycardia or survived sudden death.

  6 months

Secondary Outcomes (3)

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

  6 months

• 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%.

  Baseline

• On symptom severity and quality of life after CABG surgery.

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saline solution with autologous plasma.

Procedure: Injection of stem cells at time of coronary artery bypass grafting

CD133+ stem cells

EXPERIMENTAL

Autologous CD133+ intramyocardial injection at time of coronary artery bypass grafting.

Procedure: Injection of stem cells at time of coronary artery bypass grafting

Interventions

Injection of stem cells at time of coronary artery bypass grafting PROCEDURE

Following completion of the distal coronary artery bypasses, autologous CD133+ stem cells,or placebo solution containing plasma and indistinguishable will be injected in the myocardium. A total of 2.0 ml with 10-15 injections will be injected.

Also known as: CD133+ autologous stem cells OR placebo solution containing autologous plasma

CD133+ stem cells; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, AND who have undergone diagnostic coronary angiography demonstrating ≥70% diameter narrowing of at least 2 major coronary arteries or branches or ≥50% diameter narrowing of the left main coronary artery.
• A significant left ventricular systolic dysfunction evaluated by echocardiography or LV angiography (LV ejection fraction ≤45% but ≥25%) due to prior myocardial infarction. This area of left ventricular dysfunction should be akinetic or severely hypokinetic, not dyskinetic or aneurismal, when assessed by echocardiography or LV angiogram. This territory should be irrigated by one or a branch of the three major vascular territories (i.e. right coronary artery, left circumflex, or left anterior descending artery distribution) that will be bypassed during the surgical procedure.
• Willingness to participate and ability to provide informed consent.

You may not qualify if:

• Contraindications to magnetic resonance imaging 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 (thus precluding performance of follow-up MR scans), claustrophobia.
• Lack of ischemic symptoms (angina) prior to referral for CABG (i.e., patients with only 'silent' ischemia will be excluded).
• Need for urgent or emergent revascularization.
• Need 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. troponin), and/or worsening ECG changes.
• Prior CABG surgery.
• Stroke within 3 months prior to planned 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 elevation of 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 in the judgment of the attending cardiologist or cardiac surgeon
• Contra-indication for bone marrow aspiration (Thrombocytopenia \<50.000 mm3, INR \>2.0, use of antiplatelet agents other than aspirin).
• 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 hrs prior to surgery and an unexplained white blood cell count in excess of 10,000/mm3
• Myelodysplastic syndrome (MDS)
• Significant cognitive impairment

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Miltenyi Biotec, Inc.: collaborator
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator
• Maisonneuve-Rosemont Hospital: collaborator

Study Sites (1)

Centre de recherche du CHUM (CRCHUM)

Montreal, Quebec, H2W 1T8, Canada

Location

Related Publications (1)

• 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.

  PMID: 27665225 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Nicolas Noiseux, MD, MSc, FRCSC

  Montreal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stem cell or placebo

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 16, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2016
• Last Updated: October 18, 2017

Record last verified: 2015-07

Locations

CA (1)