A Closed-Loop Living-Form Reprogramming Device Platform (ECBP): System Design, Evidence Stratification, and a Falsifiable Research Programme

【Concept & Protocol Preprint — NO empirical results are claimed.】 Background. Adult mammals default to fibrotic repair rather than regeneration after amputation proximal to the terminal phalanx, deep burns, or large soft-tissue loss. Bioelectric research indicates that transmembrane potential (Vmem) and gap-junction-mediated coupling constitute a layer of positional information above the genome that is externally addressable. A 24-hour exposure to a wearable bioreactor was reported to trigger long-term (18-month) limb regeneration in adult Xenopus laevis, suggesting that "brief trigger, long autonomous execution" is a tractable intervention paradigm. Aim. This paper does not attempt to reproduce those results. It asks an engineering question: if brief trigger-mode morphogenetic intervention is to be built as a manufacturable, regulable, and falsifiable device, what is its minimal sufficient design, and where are its boundaries? Methods. We present a layered design for the ECBP (Electro-Chemical Bio-hybrid Patch) platform and annotate every technical claim with one of three evidence tiers: E1 (supported by peer-reviewed evidence), E2 (reasonable engineering extrapolation, no direct evidence), E3 (speculative, currently unsupported). We provide (i) a design-target parameter table and an analytic safety envelope for the trigger-mode patch ECBP-Lite; (ii) a blinded, controlled experimental programme for a rat middle-phalanx amputation model with explicit falsification criteria; and (iii) an itemised exclusion list of claims we deliberately reject, with reasons. Results (design-level). Four design principles: trigger over closed-loop; passive over active; macroscopic cueing over microscopic micromanagement; falsification criteria before engineering detail. The resulting ECBP-Lite is a pump-free, sensor-free, single-use passive patch removed at 24 hours. Conclusions and limits. We explicitly do NOT propose the conceived whole-body "Bio-Electric Regeneration Chamber (BERC)" for any human study, and give specific physiological and safety objections, including a direct rejection of the claim that locking systemic Vmem at -70 mV constitutes rejuvenation — a claim that conflicts with the observed association between depolarised Vmem and proliferative/plastic cell states. This paper does not provide medical advice. The device described has not entered any animal or human study and has not been approved by any regulatory authority.