MSC Digital Assetization for Personalized Regenerative Medicine: An AI–Blockchain–Digital Twin Integrated Framework

Mesenchymal stem cells (MSCs) are a critical biological resource for regenerative medicine, immunomodulation, and personalized cell therapy. Three structural problems persist: (1) the absence of standardized, quantitative quality indicators; (2) insufficient tamper-proof traceability throughout the manufacturing and banking lifecycle; and (3) the lack of a personalized matching system linking MSC batch characteristics to patient-specific clinical requirements. This paper proposes the MSC Digital Assetization Framework (MDAF), an applied engineering framework that addresses all three problems at the architectural and prototype level. Here, digital assetization—the transformation of a biological product into a structured, traceable, and transferable digital quality record within a multi-institutional trust infrastructure—denotes verifiable, traceable, quality-certified digital recordization of MSC batches, not tokenization or financial trading. The quality engine integrates morphological, FLIM-derived metabolic–proliferative, donor blood panel, flow cytometry, and manufacturing metadata inputs through a bidirectional Cross-Attention fusion module, yielding a continuous MSC quality score (MQS, 0–100) and an S/A/B/C/D five-tier grade. Privacy-preserving verification is implemented via two independent Groth16 zero-knowledge proof circuits: a Release Eligibility Proof (REP, MQS ≥ 70) and a Premium Quality Proof (PQP, MQS ≥ 85). A Hyperledger Besu QBFT permissioned blockchain with smart contracts provides immutable lifecycle traceability and DID-based access control. In a synthetic data pilot (n = 2000), the system demonstrated engineering feasibility across all five subsystems. These results are engineering pipeline feasibility benchmarks on synthetic data; biological and clinical validation using real MSC data is mandatory follow-on research.