Stem Cell Implantation in Patients Undergoing CABG

NCT01721902 | Terminated Phase 1 DMC

• 2 other identifiers: 0801-133808756
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to demonstrate the feasibility and safety of intra-operative, intra-myocardial injection of autologous CD133 positive bone marrow cells at the time of coronary artery bypass graft (CABG) surgery in patients with chronic ischemic cardiomyopathy. Additionally, the feasibility of producing autologous CD133+ bone marrow stem cells will be assessed. The investigators hypothesize that collection of a sufficient number of CD133+ cells through bone marrow aspiration prior to surgery, with subsequent processing and intra-myocardial injection of high purity cells following completion of CABG, will be feasible without significant adverse clinical consequences.

Conditions

Ischemic Cardiomyopathy; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Freedom from a Major Adverse Cardiac Event (MACE)

  Defined as cardiac death, myocardial infarction (CK/CK-MB over 5 times the upper limit of normal), repeat coronary bypass grafting, or a repeat percutaneous intervention of bypassed coronary artery.

  Six months

• Feedom from any major arrhythmias

  Defined as sustained ventricular tachycardia or survived sudden death.

  Six months

Secondary Outcomes (2)

• Regional myocardial perfusion and function assessed by comparing paired magnetic resonance scans, ECHOs and SPECT scans obtained prior to CABG and again at 6 months post CABG.

  6 months

• Symptom severity and quality of life at 6 months after CABG surgery.

  6 months

Study Arms (2)

Autologous CD133+ Bone Marrow Stem Cells

ACTIVE COMPARATOR

Intra-myocardial injection of autologous CD133+ cells in suspension.

Device: Autologous CD133+ Bone Marrow Stem Cells

Carrier Solution

PLACEBO COMPARATOR

Intra-myocardial inception of carrier solution.

Other: Carrier Solution

Interventions

Autologous CD133+ Bone Marrow Stem Cells DEVICE

Intra-myocardial injection of 2-3 x 10E6 CD133+ Bone Marrow Stem Cells

Autologous CD133+ Bone Marrow Stem Cells

Carrier Solution OTHER

Intra-myocardial injection of carrier solution

Carrier Solution

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Patients with ischemic heart disease manifested by Canadian class II or greater angina and/or New York Heart Association class II, III or IV exercise intolerance AND who have undergone diagnostic coronary angiography demonstrating at least 70% diameter narrowing of at least 2 major coronary arteries or branches or at least 50% diameter narrowing of the left main coronary artery.
• Left ventricular systolic dysfunction evaluated by echocardiography or LV angiography (LV ejection fraction less than or equal to 49%).
• Willingness to participate and ability to provide informed consent

You may not qualify if:

• Contraindications to magnetic resonance imaging .
• Need for emergent revascularization.
• Need for concomitant surgical procedure at the time of CABG (e.g. valve repair or replacement, aneurysm resection, etc.).
• Hemodynamically unstable patients.
• Patients with confirmed transmural myocardial infarction within 4 weeks, and/or rising cardiac biomarker proteins (i.e. troponin), and/or worsening ECG changes.
• Prior CABG surgery.
• Stroke within 1 month prior to planned CABG.
• Diagnosed with human immunodeficiency virus (HIV) or any other immune disorder or immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.)
• Organ dysfunction
• Contra-indication for bone marrow aspiration (Thrombocytopenia \< 50.000 mm3, INR \> 2.0, use of antiplatelet agents other than aspirin).
• Hemoglobin less than 8g/dL, white blood cell count less than 4,000/mm3, absolute neutrophil count less than 1500/mm3
• Active infection
• Myelodysplastic syndrome (MDS)
• Significant cognitive impairment
• Any condition associated with a life expectancy of less than 6 months

Sponsors & Collaborators

• Miltenyi Biotec, Inc.: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yi-Ping J Woo, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: November 6, 2012
• Study Start: January 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

US (1)