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Mesoblast Receives FDA Approval for First MSC Therapy for Steroid-Refractory Acute Graft-Versus-Host Disease

• Mesoblast's mesenchymal stromal cell (MSC) therapy has gained FDA approval for steroid-refractory acute graft-versus-host disease (SR-aGVHD). • This approval marks a significant advancement in regenerative medicine, highlighting the potential of MSC therapies. • Pluri Inc. congratulates Mesoblast, emphasizing the importance of this milestone for the entire field of cellular medicine. • The FDA's decision underscores the opportunity to accelerate the development of MSC-based therapies globally, according to Pluri.

The U.S. Food and Drug Administration (FDA) has approved Mesoblast Ltd.'s mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft-versus-host disease (SR-aGVHD), marking a pivotal moment in regenerative medicine. This approval signifies the first MSC-based therapy available for this challenging condition.
Pluri Inc., a company focused on cell-based technologies, congratulated Mesoblast on this achievement. Yaky Yanay, Chief Executive Officer and President of Pluri, stated, "This milestone is not just a triumph for Mesoblast, but for the entire field of cellular medicine. This approval validates the immense therapeutic promise of MSCs and inspires all of us working in this space to redouble our efforts to bring innovative solutions to patients in need."

Impact on Regenerative Medicine

The FDA approval underscores the transformative potential of regenerative medicine in healthcare. Regenerative therapies aim to address the root causes of diseases, potentially improving patient outcomes and creating more sustainable healthcare systems. MSCs, with their ability to modulate the immune system and promote tissue repair, hold promise for treating various conditions.

Pluri's Perspective

Pluri has been a long-time advocate for MSCs, utilizing its 3D cell-expansion technology to develop scalable cell-based therapies. The company believes that the FDA's decision highlights the importance of accelerating the development of MSC-based therapies worldwide.
Pluri's PLacental eXpanded cells are placenta-derived, mesenchymal-like adherent stromal cells which are being studied for the treatment of hematopoietic indications such as Acute Radiation Syndrome as well as orthopedic indications such as Knee Osteoarthritis.
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Reference News

[1]
Pluri Congratulates Mesoblast on FDA Approval of First Mesenchymal Stromal Cell Therapy ...
finance.yahoo.com · Dec 19, 2024

Pluri Inc. congratulates Mesoblast Ltd. on FDA approval of the first MSC-based therapy for SR-aGVHD, marking a pivotal m...

[2]
Pluri Congratulates Mesoblast on FDA Approval of First - GlobeNewswire
globenewswire.com · Dec 19, 2024

Pluri Inc. congratulates Mesoblast on FDA approval of the first MSC-based therapy for SR-aGVHD, highlighting regenerativ...

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