Collaboration to Advance First-in-Human Clinical Study Using Autologous iPSC Technology

Cellino, a biotechnology company pioneering autonomous biomanufacturing for personalized regenerative medicine, today announced its expansion into the Asia-Pacific region through a strategic collaboration with Karis Bio, a leading South Korean cell therapy biotech. The partnership aims to industrialize the world’s first clinical-stage autologous induced pluripotent stem cell (iPSC)-derived cell therapy for peripheral artery disease (PAD) and coronary artery disease (CAD).

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Photo caption: Karis Bio iPSC-Derived Endothelial Cells. Photo credit: Karis Bio

The collaboration is set to accelerate the development of Karis Bio’s innovative autologous iPSC-derived endothelial cell (iPSC-EC) therapy designed to generate new blood vessels in ischemic organs. Karis Bio’s first-in-human clinical study in South Korea leverages patient-specific iPSCs to restore blood flow and repair damaged tissues, offering patients a revolutionary alternative to conventional invasive procedures such as stents or bypass surgery, while eliminating the risk of immune rejection.

Cellino’s Nebula™ platform will enable scalable, high-quality production of autologous iPSCs, accelerating Karis Bio’s path to commercial scale. The Nebula™ platform is a closed-cassette, advanced biomanufacturing system that is both autonomous and deployable at the point of care, ensuring robust, reproducible, and contamination-free production. The initial phase of the collaboration focuses on industrializing autologous iPSC manufacturing, with plans to expand into Phase 2 trials through Karis Bio, USA (headquartered in Atlanta) in the U.S.

“We are excited to partner with Karis Bio to pioneer the world’s first Nebula™-powered autologous iPSC therapy for peripheral artery disease,” said Nabiha Saklayen, Ph.D., CEO & Co-Founder of Cellino. “This collaboration solidifies our commitment to forging powerful alliances with the world’s leading therapeutics innovators.”

“Our inaugural first-in-human study using an autologous iPSC-derived therapy in South Korea is a pivotal advancement in regenerative medicine,” said Young-sup Yoon, M.D., Ph.D., CEO of Karis Bio. “This collaboration with Cellino will mutually leverage the strengths of both organizations, using Cellino’s Nebula™ platform and Karis Bio’s vessel regeneration technology to pave the way for the next generation of patient-specific cardiovascular disease therapies to be delivered worldwide.”

This collaboration marks Cellino’s inaugural expansion into the Asia-Pacific region and underscores its global vision to make autologous cell therapies widely accessible. By integrating AI-driven automation, robotics, and high-throughput biomanufacturing, Cellino and Karis Bio are poised to accelerate the development of personalized regenerative medicines for patients with cardiovascular disease.

About Cellino

Cellino is a leader in advanced biomanufacturing technology, committed to making personalized cell, tissue, and organ replacements a reality for patients around the world. Learn more at www.cellinobio.com and follow us on LinkedIn and X.

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