Curing the Incurable with ‘Biological Age Zero’ Cells: Clonell™ Launches the Ultimate Regenerative Medicine Platform

Fundamental Cure for Intractable and Incurable Diseases using ‘Biological Age Zero’ Cells Derived from Patient’s Own Cells via SCNT TechnologyWorld's First Therapy Platform Simultaneously Solving Immune Rejection and Inheritance of Cellular Aging—The Major Hurdles of Existing Stem Cell TherapiesDrastically Improving Treatment Accessibility through the New Paradigm, ‘Patient-Initiated Clinical Trial™’, which Overcomes Existing Clinical Limitations

Clonell Therapeutics, Inc., a leading biotechnology company dedicated to curing intractable and incurable diseases, announced today the official launch of the world's first 'Patient-Specific Embryonic Stem Cell (Somatic Cell Nuclear Transfer-derived Embryonic Stem Cell, hereinafter SCNT-ESC)' therapy platform based on Somatic Cell Nuclear Transfer (SCNT) technology. Concurrently, the company has initiated its innovative 'Patient-Initiated Clinical Trial™' to apply this breakthrough technology directly to patients.

This platform launch is evaluated as presenting the true 'Gold Standard' in regenerative medicine by perfectly resolving the inherent challenges—such as immune rejection, incomplete reprogramming, and the inheritance of aging—that have been cited as limitations of existing stem cell therapies. Clonell's SCNT technology establishes a patient-specific embryonic stem cell line by transferring the nucleus of a patient's somatic cell into a healthy enucleated oocyte. This process ensures a 100% DNA match with the patient, thereby eliminating immune rejection. Through the powerful reprogramming capability of the oocyte's cytoplasm, the patient's cells are epigenetically reset completely, reborn as pluripotent stem cells with a 'biological age of zero' where even aged mitochondria, ribosomes, and other organelles are replaced with healthy ones.

In contrast, induced pluripotent stem cells (iPSCs) possess inherent limitations such as the 'persistence of epigenetic memory' and the 'inheritance of aged organelles'. For example, iPSCs derived from skin cells may retain memories of being skin cells, exhibiting resistance when differentiating into other cell types (e.g., neurons, cardiomyocytes) or a tendency to revert to their original lineage, which becomes a significant obstacle in stably and efficiently obtaining therapeutic cells. Furthermore, considering mitochondria, one of the intracellular organelles and the cell's energy factory, iPSCs inherit the patient's aged mitochondria as they are. Consequently, they exhibit low energy (ATP) production efficiency and high generation of harmful Reactive Oxygen Species (ROS), leading to significantly reduced functionality as a therapeutic agent when differentiated into neurons or cardiomyocytes that require immense energy.

Clonell aims for the complete 'conquest' of diseases that have previously been impossible to cure fundamentally—ranging from neurodegenerative diseases such as Alzheimer's disease, ALS (Lou Gehrig's disease), and Stroke, to cardiovascular diseases like Heart Failure, and Aging-related diseases—through its SCNT-ESC treatment platform, which has fundamentally resolved these technical challenges. Beyond simple symptom mitigation, Clonell targets the Functional Restoration of damaged tissues and organs. Through this, the company is now realizing the dream of conquering intractable and incurable diseases—which had long existed only as a theoretical possibility—into a practical treatment strategy.

In particular, Clonell has completed a high-efficiency production system essential for commercialization by applying its proprietary technology, ‘Selection of donor cells and somatic cell nuclear transfer composition for improving cloned embryo development efficiency, and somatic cell nuclear transfer method using the same (Patent Pending)’, which secures more than double the SCNT-ESC production efficiency compared to conventional methods. This unique technology maximizes the oocyte's natural reprogramming ability, representing Clonell's unique competitive edge in the highly technical SCNT field.

Furthermore, Clonell has introduced a new paradigm called the ‘Patient-Initiated Clinical Trial™’ to overcome the limitations of traditional pharmaceutical company-led clinical trials, which require enormous costs and time. This is an innovative partnership model where the patient who urgently requires treatment becomes the initiator of the clinical trial, funding the commencement of their own treatment, while Clonell provides patient-specific therapeutics with its unrivaled technology. In this process, Clonell guarantees the transparency of clinical cost management and the safety of patient funds by adopting the global payment protection system, Escrow (Escrow.com). Subsequently, Clonell supports the entire process so that patients can receive customized treatment safely and rapidly through legal regulatory pathways, such as in-hospital clinical research and treatment under Japan's ‘Act on the Safety of Regenerative Medicine (ASRM)’ and the U.S. FDA's ‘Expanded Access Program’, specifically the ‘Single Patient Investigational New Drug (IND)’.

"Clonell's SCNT-ESC platform is medically the ultimate therapeutic platform, possessing absolute superiority in terms of safety and efficacy that no other therapeutic platform can match," said Dr. Hyo-Sang Lee, Chief Scientific Officer (CSO) of Clonell and a key figure in the research team at Oregon Health & Science University (OHSU) that successfully established the world's first human SCNT-ESC in 2013. He added, "This is because this technology provides the most ideal therapeutic raw materials capable of realizing the most ideal treatment strategies allowed by medical imagination for the most difficult diseases humanity faces."

More information about Clonell's therapy platform and Patient-Initiated Clinical Trials can be found on the official website (www.clonell.com).

About Clonell Therapeutics, Inc.

Clonell is a biotechnology company developing fundamental cures for intractable and incurable diseases through Therapeutic Cloning technology. Based on unrivaled technical prowess in the field of Patient-Specific Embryonic Stem Cells (SCNT-ESC), the company possesses a diverse pipeline covering neurodegenerative diseases, cardiovascular diseases, and aging-related diseases. With 'Patient-Centric Innovation' as a core value, Clonell is increasing accessibility to cutting-edge regenerative medicine technology through its Patient-Initiated Clinical Trial™.

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