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

Completed Phase 2 Last updated 9 March 2020

What this trial tests

Phase 2 trial testing Mesenchymal Precursor Cells (MPCs) in Heart Failure in 60 participants. Completed in 1 July 2013.

Timeline

1 August 2008

Primary endpoint
1 June 2011

1 July 2013

Quick facts

Lead sponsor	Mesoblast, Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	1 August 2008
Primary completion	1 June 2011
Estimated completion	1 July 2013
Sites	6 locations across United States

Drugs / interventions tested

• Mesenchymal Precursor Cells (MPCs) — full drug profile →
• Mesenchymal Precursor Cells (MPCs) — full drug profile →
• Mesenchymal Precursor Cells (MPCs) — full drug profile →
• standard-of-care treatment with mock mapping and injection procedures.
• standard-of-care treatment with mock mapping and injection procedures.
• standard-of-care treatment with mock mapping and injection procedures.

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Mesoblast, Ltd. — full company profile →

Who can join

Adults 20 to 80, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.
  Time frame: 3 years

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Harnessing the mesenchymal stem cell secretome for the treatment of cardiovascular disease.
   Ranganath SH, Levy O, Inamdar MS, Karp JM. · · 2012 · cited 628× · PMID 22385653 · DOI 10.1016/j.stem.2012.02.005
2. Cell therapy for heart failure: a comprehensive overview of experimental and clinical studies, current challenges, and future directions.
   Sanganalmath SK, Bolli R. · · 2013 · cited 449× · PMID 23989721 · DOI 10.1161/circresaha.113.300219
3. Mesenchymal Stem Cell (MSCs) Therapy for Ischemic Heart Disease: A Promising Frontier.
   Poomani MS, Mariappan I, Perumal R, Regurajan R, et al · · 2022 · cited 37× · PMID 35342702 · DOI 10.5334/gh.1098
4. Alloreactive Immune Response Associated to Human Mesenchymal Stromal Cells Treatment: A Systematic Review.
   Sanabria-de la Torre R, Quiñones-Vico MI, Fernández-González A, Sánchez-Díaz M, et al · · 2021 · cited 37× · PMID 34279481 · DOI 10.3390/jcm10132991
5. Mesenchymal Stem Cells Therapies on Fibrotic Heart Diseases.
   Gubert F, da Silva JS, Vasques JF, de Jesus Gonçalves RG, et al · · 2021 · cited 29× · PMID 34299066 · DOI 10.3390/ijms22147447
6. Trophic actions of bone marrow-derived mesenchymal stromal cells for muscle repair/regeneration.
   Sassoli C, Zecchi-Orlandini S, Formigli L. · · 2012 · cited 22× · PMID 24710532 · DOI 10.3390/cells1040832
7. Cellular Therapy for Heart Failure.
   Psaltis PJ, Schwarz N, Toledo-Flores D, Nicholls SJ. · · 2016 · cited 20× · PMID 27280304 · DOI 10.2174/1573403x12666160606121858
8. Concise Review: Mending a Broken Heart: The Evolution of Biological Therapeutics.
   Chen C, Termglinchan V, Karakikes I. · · 2017 · cited 12× · PMID 28233392 · DOI 10.1002/stem.2602