A Phase II Dose-escalation Study to Assess the Feasibility and Safety of Transendocardial Delivery of Three Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs)in Subjects With Heart Failure

NCT00721045 | Completed Phase 2 DMC

• 1 other identifier: HF-AB002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief Summary

This is a dose-ranging clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture expanded, nucleated, allogeneic MPCs in subjects who have cardiomyopathy of both ischemic and idiopathic etiology.

Conditions

Heart Failure

Keywords

Heart Failure; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to evaluate the feasibility and safety of transendocardial injection using mapping Catheter with the Left Ventricular Injection Catheter of 25 M, 75 M, and 150 M allogeneic MPCs in subjects with heart failure.

  3 years

Secondary Outcomes (1)

• The secondary objectives are to explore functional efficacy for subsequent study design.

  3 years

Study Arms (6)

A1

ACTIVE COMPARATOR

15 subjects randomized to receive 25 M allogeneic MPCs by transendocardial injection and mapping.

Biological: Mesenchymal Precursor Cells (MPCs)

A2

SHAM COMPARATOR

5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures.

Procedure: standard-of-care treatment with mock mapping and injection procedures.

B1

ACTIVE COMPARATOR

15 subjects randomized to receive 75 M allogeneic MPCs by transendocardial injection and mapping.

Biological: Mesenchymal Precursor Cells (MPCs)

B2

SHAM COMPARATOR

5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures.

Procedure: standard-of-care treatment with mock mapping and injection procedures.

C1

ACTIVE COMPARATOR

15 subjects randomized to receive 150 M allogeneic MPCs by transendocardial injection and mapping.

Biological: Mesenchymal Precursor Cells (MPCs)

C2

SHAM COMPARATOR

5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures.

Procedure: standard-of-care treatment with mock mapping and injection procedures.

Interventions

Mesenchymal Precursor Cells (MPCs) BIOLOGICAL

25 M allogeneic MPCs by transendocardial injection and mapping.

Also known as: Revascor

A1

standard-of-care treatment with mock mapping and injection procedures. PROCEDURE

Mock

A2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NYHA ≥ 2.
• Age \>20 and \<80.
• Cardiomyopathy of ischemic or idiopathic etiology.
• Subject is not a candidate for either percutaneous intervention or cardiac surgery as determined by both an interventional cardiologist and a cardiac surgeon.
• LVEF (Left ventricular ejection fraction) \< 40% via 2-D Echocardiogram within 28 days of study procedure.
• On stable maximal, tolerable dosages of heart failure therapies including betablockers,ace inhibitors and/or diuretics with no interruption or change in medical therapy for at least 28 days prior to study enrollment.
• Left Ventricle wall thickness ≥ 8mm at target site by echo within 28 days of study procedure.
• If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure.
• Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
• Willing and able to understand, sign, and date the Informed Consent Form (ICF).
• Must be willing to return for required follow-up visits.
• Must be able to follow postoperative management program.

You may not qualify if:

• Acute Myocardial Infarction in past 30 days.
• Discharge of subject's ICD within 28 days of study procedure.
• Sustained Ventricular Tachycardia as demonstrated by QRS complexes wider than 120 msec, lasting \>30 secs, and \>100 bpm documented in screening ECG or 24 hour Holter monitoring.
• Unstable angina.
• LV thrombus by echocardiogram or angiogram with 28 days prior to and up to the time of cell injection.
• Aortic stenosis as determined by echocardiography as valve area less than 1 cm2 that prohibits NOGA catheter access to LV.
• Cardiogenic shock defined as the need for intravenous inotropic support, an intraaortic balloon pump, or mechanical circulatory support at the time of cell injections.
• Chronic AF or AF at the time of cell injections.
• Unprotected left main coronary artery disease \>50%.
• Ischemic or hemorrhagic stroke as diagnosed by CT/MRI events within the last 3 months prior to enrollment.
• Bleeding diathesis disorder such as abnormal coagulation profile precluding performing of mapping/injection procedure.
• Serum glucose level \> 400 mg/dl within 28 days of study procedure.
• Serum glucose level 300 to 400 mg/dl and presence of urine ketones within 28 days of study procedure.
• Creatinine level ≥ 2.5 mg/dL within 28 days of study procedure.
• Hematocrit ≤ 32% within 28 days of study procedure.

Sponsors & Collaborators

• Mesoblast, Ltd.: lead

Study Sites (6)

Mercy Gilbert Medical Center

Gilbert, Arizona, 85297, United States

Location

University of California, San Diego

La Jolla, California, 92037-1300, United States

Location

Minneapolis Heart Institute 920 East 28th St, Suite 300

Minneapolis, Minnesota, 55407-1139, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Texas Heart Institue

Houston, Texas, 77030, United States

Location

Swedish Heart and Vascular Institute

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Injections

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Emerson Perin, MD

  Texas Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 23, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2013
• Last Updated: March 11, 2020

Record last verified: 2015-05

Locations

US (6)