Cellino Partners with Karis Bio for Autologous iPSC Therapy to Treat Cardiovascular Disease
This collaboration aims to advance a first-in-human clinical study by using autologous iPSC technology.
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On Apr 15, 2025, US-based Cellino, a biotechnology company specializing in autonomous biomanufacturing for personalized regenerative medicine, announced a strategic collaboration with South Korea-based Karis Bio, a cell therapy biotech. Through the partnership, the companies aim to industrialize a clinical-stage autologous induced pluripotent stem cell (iPSC)-derived cell therapy, the world’s first, according to the companies, for treating peripheral artery disease and coronary artery disease. The collaboration also expands Cellino’s presence in the Asia-Pacific region, according to a company press release (1).
Under the partnership, the development of Karis Bio’s innovative autologous iPSC-derived endothelial cell (iPSC-EC) therapy will be accelerated. This therapy is designed to generate new blood vessels in ischemic organs. In a first-in-human clinical study in South Korea, Karis Bio will leverage patient-specific iPSCs to restore blood flow and repair damaged tissues. This therapy aims to offer patients an alternative to conventional invasive procedures, such as stents or bypass surgery, while eliminating the risk of immune rejection.
“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, PhD, CEO and co-founder, Cellino, in the press release (1). “This collaboration solidifies our commitment to forging powerful alliances with the world’s leading therapeutics innovators.”
In the collaboration, Cellino will use its Nebula technology platform to enable scalable, high-quality production of autologous iPSCs, which is expected to accelerate Karis Bio’s path to commercial-scale production. The Nebula platform comprises a closed-cassette, advanced biomanufacturing system. It is both autonomous and deployable at the point-of-care, which ensures robust, reproducible, and contamination-free production. The initial phase of the collaboration will focus on industrializing the autologous iPSC manufacturing. Expansion into Phase II trials is planned to go through Karis Bio.
“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, MD, PhD, CEO of Karis Bio, in the release. “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 partnership marks the start of Cellino’s expansion into the Asia-Pacific region. The company’s goal is to make autologous cell therapies widely accessible. Through the integration of artificial-intelligence-driven automation, robotics, and high-throughput biomanufacturing, the two companies expect to accelerate the development of personalized regenerative medicines for patients with cardiovascular disease.
iPSC-derived cell therapy offers a promising approach for regenerative medicine by enabling the generation of patient-specific cells. Importantly, iPSCs can be differentiated into various cell types, thus they provide a renewable source for replacing damaged or diseased tissues. The promise of this approach lays in the fact that it mitigates immune rejection risks and addresses donor shortages. Recent advancements being made in this field focus on improving differentiation efficiency, genomic stability, and clinical safety. iPSC-derived cell therapies have applications in treating neurodegenerative diseases, cardiac conditions, and diabetes. However, challenges remain in scalability, tumorigenicity, and regulatory hurdles. Ongoing research aims to optimize protocols and ensure consistent, safe, and effective therapeutic outcomes for widespread clinical use (2).
References
1. Cellino. Cellino Announces Partnership with Karis Bio to Develop First Nebula-Powered Autologous iPSC Therapy for Cardiovascular Disease. Press Release. April 15, 2025.
2. Madrid, M.; Lakshmipathy, U.; Zhang, X.; et al. Considerations for the Development of iPSC-Derived Cell Therapies: A Review of Key Challenges by the JSRM-ISCT iPSC Committee. Cytotherapy 2024, 26 (11), 1382–1399. DOI: 10.1016/j.jcyt.2024.05.022
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