Details

Autor(en) / Beteiligte

• Hare, Joshua M., MD
• DiFede, Darcy L., RN BSN
• Castellanos, Angela M., MD MSc
• Florea, Victoria, MD
• Landin, Ana M., PhD
• El-Khorazaty, Jill, MSc
• Khan, Aisha, MSc MBA
• Mushtaq, Muzammil, MD
• Lowery, Maureen H., MD
• Byrnes, John J., MD
• Hendel, Robert C., MD
• Cohen, Mauricio G., MD
• Alfonso, Carlos E., MD
• Valasaki, Krystalenia, MSc
• Pujol, Marietsy V., MDA
• Golpanian, Samuel, MD
• Ghersin, Eduard, MD
• Fishman, Joel E., MD PhD
• Pattany, Pradip, PhD
• Gomes, Samirah A., MD PhD
• Delgado, Cindy, MFA
• Miki, Roberto, MD
• Abuzeid, Fouad, MD
• Vidro-Casiano, Mayra, MPH
• Premer, Courtney, BSc
• Medina, Audrey, BSc
• Porras, Valeria, BSc
• Hatzistergos, Konstantinos E., PhD
• Anderson, Erica, MSc
• Mendizabal, Adam, PhD
• Mitrani, Raul, MD
• Heldman, Alan W., MD

Titel

Randomized Comparison of Allogeneic Vs. Autologous Mesenchymal Stem Cells for Non-lschemic Dilated Cardiomyopathy: POSEIDON-DCM Trial

Ist Teil von

• Journal of the American College of Cardiology, 2016-11, Vol.69 (5), p.526-537

Erscheinungsjahr

2016

Link zum Volltext

Quelle

Elsevier ScienceDirect Journals Complete

Beschreibungen/Notizen

• Abstract Background While human mesenchymal stem cells (hMSCs) have been tested in ischemic cardiomyopathy, few studies exist in chronic non-ischemic dilated cardiomyopathy (NIDCM). Objectives The POSEIDON-DCM trial is a randomized comparison of safety and efficacy of autologous (auto) vs. allogeneic (allo) bone marrow-derived hMSCs in NIDCM. Methods Thirty-seven patients were randomized to either allo- or auto-hMSCs in a 1:1 ratio. Patients were recruited between December 2011 and July 2015 at the University of Miami Hospital. Patients (age: 55.8 + 11.2; 32% female) received hMSCs (100 million) by transendocardial stem cell injection (TESI) in ten left ventricular sites by NOGA Catheter. Treated patients were evaluated at baseline, 30 days, 3-, 6-, and 12-months for safety: serious adverse events (SAE), and efficacy endpoints: Ejection Fraction (EF), Minnesota Living with Heart Failure Questionnaire (MLHFQ), Six Minute Walk Test (6MWT), MACE, and immune-biomarkers. This trial is registered with ClinicalTrials.gov , #NCT01392625. Results There were no 30-day treatment-emergent (TE)-SAEs. 12-month SAE incidence was 28.2% (95% CI: 12.8, 55.1) in allo, and 63.5% (95% CI: 40.8, 85.7; p=0.1004) in auto. One allo-group patient developed an elevated donor specific cPRA. EF increased in allo by 8.0 units (95% Cl: 2.8, 13.2; p=0.004), and in auto: 5.4 units (95% Cl: -1.4, 12.1; p=0.116, allo vs. auto p=0.4887). 6MWT increased for allo: 37.0 meters (95% Cl: 2.0 to 72.0; p=0.04), but not auto: 7.3 meters (95% Cl: -47.8, 33.3; p=0.71, auto vs. allo p=0.0168). MLHFQ score decreased in allo (p=0.0022), and auto (p=0.463; p=0.172). The MACE rate was lower in allo vs. auto (p=0.0186). Tumor necrosis factor alpha (TNF-α) decreased (p=0.0001 for each), to a greater extent in allo vs. auto at six-months (p=0.05). Conclusion These findings demonstrate safety and support greater, clinically meaningful efficacy of allo-hMSC vs. auto-hMSC in NIDCM patients. Pivotal trials of allo-hMSCs are warranted based on these results.