Registry of Outcomes of Dezawa MuseCells®

Multilineage-Differentiating Stress-Enduring (MUSE) cells represent a unique and promising class of endogenous, non-tumorigenic pluripotent-like stem cells. First identified and characterized by Professor Mari Dezawa and her team in 2010, these cells are a naturally occurring somatic stem cells found in the bone marrow, connective tissues of various adult organs, including adipose tissue and dermis, as well as in the peripheral blood. MUSE cells exhibit a "double-feature" profile, combining the most desirable attributes of both pluripotent stem cells like embryonic stem cells and adult mesenchymal stem cells (MSCs). Crucially, this pluripotent-like capacity is coupled with an intrinsic safety mechanism that prevents tumorigenesis. This combination allows MUSE cells to offer the broad regenerative capabilities of pluripotency without the associated oncogenic risks, a major advantage in clinical translation. A cornerstone of MUSE cell therapy is their remarkable immune privilege, which enables the development of "off-the-shelf" therapies.

MUSE cells carry the unique properties of stress-resilience, pluripotency-like and efficient homing to damaged tissue, only a preparation highly enriched for MUSE cells will deliver the therapeutic benefits attributed to "muse cells. Thus, any MSC preparation with substantially less than ~70 % Muse cells are effectively dominated by non-Muse MSCs; in that context the bulk behavior (multipotent, immunomodulatory, limited differentiation) will reflect the MSC phenotype, not the true Muse phenotype, so calling it "muse cells" would be misleading. Because Muse cells naturally constitute only a small fraction of generic MSC isolates, a preparation labeled "Muse cells" but in reality, largely composed of non-Muse MSCs will lack the key properties demonstrated in preclinical/clinical work. Preclinical and clinical efficacy (homing to damaged tissue, differentiation, repair, functional recovery) has been shown specifically with Dezawa MuseCell® products not with mixed MSC populations.

MuseCell Innovations Pte Ltd (MCI) is the exclusive worldwide licensor for the production, distribution, and commercialization of genuine Dezawa MuseCells®, the only clinically validated pluripotent-like, non-tumorigenic, immune-tolerant stem cell platform derived from the scientific work and intellectual property of Professor Mari Dezawa. These authorized and licensed laboratories follow proprietary, patented methodologies licensed directly from MCI and maintain strict controls for sterility, identity, potency, clean-room processing, documentation, and product traceability. This structure ensures that every Dezawa MuseCells® product regardless of country of delivery meets the highest scientific, ethical, and quality standards established by MCI and validated with ongoing global clinical research. Dezawa MuseCells® require licensed, high-purity (≥70% SSEA-3⁺) enrichment and rigorous manufacturing that cannot be performed cheaply, so any low-cost product is simply unpurified MSCs mislabeled as Muse and cannot deliver true Muse-cell effects and may have potential side effects.

This observational, multi-year patient registry is designed to generate a comprehensive understanding of the short-term and long-term clinical outcomes associated with Dezawa MuseCells® when administered as part of routine medical care for a variety of diseases. The study seeks to characterize therapeutic response trajectories, durability of benefit, patient-reported symptomatic changes, and any safety signals that emerge across a five-year follow-up period. Because participants receive Dezawa MuseCells® outside the context of the study protocol, this registry functions exclusively as a structured outcomes-tracking platform rather than an interventional trial. Enrolled participants will complete scheduled online surveys capturing symptoms, quality of life, functional status, adverse events, and other clinically relevant measures at predefined intervals extending through five years.

To ensure high data fidelity, the registry incorporates a formal quality assurance plan that governs data validation and process control. All submitted patient-reported information undergoes automated data checks to confirm adherence to predefined rules for logical range, internal consistency, and compatibility with related fields. Source data verification procedures allow registry personnel to compare a subset of patient-reported entries to external medical records or clinician documentation to assess representativeness and completeness. A controlled data dictionary defines every variable collected within the registry, including source fields, coding frameworks where appropriate, and any relevant standard ranges to support consistent analysis across timepoints. Standard Operating Procedures (SOPs) guide every operational element-patient recruitment, digital survey workflows, longitudinal data collection schedules, data management practices, adverse event reporting expectations, change-control processes, and statistical programming steps-to ensure uniformity and reproducibility of registry activities across the full duration of the study.

The planned sample size is designed to accrue a sufficient number of participants and participant-years to detect clinically meaningful trends in longitudinal outcomes, while also enabling stratified analyses across disease categories, baseline severity levels, and demographic subgroups. The statistical analysis plan outlines the descriptive and inferential approaches used to evaluate the registry's primary objective-short-term and long-term outcome patterns after Dezawa MuseCell® administration as well as secondary objectives related to symptom evolution, functional recovery, durability of response, and safety characterization. Analytical techniques may include longitudinal mixed-effects models, time-to-event analyses, subgroup comparisons, and pattern-of-missingness evaluations, all aligned with a prespecified statistical framework. Together, these procedures establish a high-quality, rigorously managed registry designed to generate meaningful real-world evidence on the long-term clinical performance of Dezawa MuseCells®.