NCT00721045

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mesoblast, Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Heart failure subjects recruited will include those who have advanced heart failure NYHA (New York Heart Association) class II to IV and a depressed ejection fraction (EF \< 40%). Baseline eligibility testing assessments will be completed within 28 days prior to cell delivery. Efficacy will be explored at 3, 6, and 12 months. This will be a single-blinded, dose-escalation, cohort study in 60 subjects allocated sequentially to 1 of 3 cohorts A, B, or C. Forty-five subjects will be randomized to receive transendocardial delivery of MPC treatment, and 15 subjects will be randomized to receive standard-of-care treatment without MPC administration. The fifteen subjects randomized to receive standard of care without needle injection will serve as the study's control population and will undergo mock mapping and verbal injection scripts.

Conditions

• Heart Failure

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal Precursor Cells (MPCs)	25 M allogeneic MPCs by transendocardial injection and mapping.
BIOLOGICAL	Mesenchymal Precursor Cells (MPCs)	75 M allogeneic MPCs by transendocardial injection and mapping.
BIOLOGICAL	Mesenchymal Precursor Cells (MPCs)	150 M allogeneic MPCs by transendocardial injection
PROCEDURE	standard-of-care treatment with mock mapping and injection procedures.	Mock
PROCEDURE	standard-of-care treatment with mock mapping and injection procedures.	Mock
PROCEDURE	standard-of-care treatment with mock mapping and injection procedures.	Mock

Timeline

• Start date: 2008-08-01
• Primary completion: 2011-06-01
• Completion: 2013-07-01
• First posted: 2008-07-23
• Last updated: 2020-03-11

Locations

6 sites across 1 country: United States