Biotechnology company Cellino announced a strategic partnership with South Korea-based Karis Bio on April 15, 2025, to accelerate the development of the world's first clinical-stage autologous induced pluripotent stem cell (iPSC)-derived cell therapy for cardiovascular diseases. The collaboration aims to industrialize an innovative treatment for peripheral artery disease (PAD) and coronary artery disease (CAD), while also expanding Cellino's presence in the Asia-Pacific region.
The partnership will focus on Karis Bio's autologous iPSC-derived endothelial cell (iPSC-EC) therapy, designed to generate new blood vessels in ischemic organs. This approach offers patients an alternative to conventional invasive procedures such as stents or bypass surgery, while eliminating the risk of immune rejection by using the patient's own cells.
Revolutionary Approach to Cardiovascular Treatment
Karis Bio has already initiated a first-in-human clinical study in South Korea using patient-specific iPSCs to restore blood flow and repair damaged tissues. The therapy represents a significant advancement in regenerative medicine for cardiovascular conditions.
"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. "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."
Nebula Platform: Enabling Scalable Production
Cellino will deploy 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 that is both autonomous and deployable at the point-of-care, ensuring robust, reproducible, and contamination-free production.
"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 of Cellino. "This collaboration solidifies our commitment to forging powerful alliances with the world's leading therapeutics innovators."
Development Roadmap
The initial phase of the collaboration will focus on industrializing the autologous iPSC manufacturing process. Following this optimization, the partners plan to expand into Phase 2 clinical trials through Karis Bio's U.S. operations, headquartered in Atlanta.
By integrating 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.
The Promise of iPSC-Derived Cell Therapy
iPSC-derived cell therapy represents a promising approach for regenerative medicine by enabling the generation of patient-specific cells. These pluripotent stem cells can be differentiated into various cell types, providing a renewable source for replacing damaged or diseased tissues.
The key advantage of this approach is that it mitigates immune rejection risks and addresses donor shortages. Recent advancements in the field have focused on improving differentiation efficiency, genomic stability, and clinical safety.
Addressing a Significant Medical Need
Peripheral artery disease and coronary artery disease represent significant health burdens globally. PAD affects approximately 200 million people worldwide and is characterized by narrowed arteries that reduce blood flow to the limbs, often resulting in pain, tissue damage, and in severe cases, amputation. CAD, the most common type of heart disease, is a leading cause of death globally.
Current treatments for these conditions typically involve medications, lifestyle changes, or invasive procedures such as angioplasty, stenting, or bypass surgery. The iPSC-EC therapy being developed through this partnership aims to provide a less invasive alternative that addresses the root cause of the disease by regenerating blood vessels.
Challenges and Future Directions
While iPSC-derived cell therapies show tremendous promise, challenges remain in scalability, potential tumorigenicity, and regulatory hurdles. The partnership between Cellino and Karis Bio specifically addresses the manufacturing scalability issue through the Nebula platform.
This collaboration marks Cellino's inaugural expansion into the Asia-Pacific region and underscores its global vision to make autologous cell therapies widely accessible. As the partners work to optimize protocols and ensure consistent, safe, and effective therapeutic outcomes, this initiative could potentially reshape the treatment landscape for cardiovascular diseases.
