# WIA-BIO-020 — Phase 2: API Interface > Regenerative-medicine canonical Phase 2: API surface (preparations + factors + applications + audit + adverse-events + cleanroom). # WIA-BIO-020: Regenerative Medicine Specification v1.0 > **Standard ID:** WIA-BIO-020 > **Version:** 1.0.0 > **Published:** 2025-12-26 > **Status:** Active > **Authors:** WIA Regenerative Medicine Research Group --- ## Table of Contents 1. [Introduction](#1-introduction) 2. [Stem Cell Types and Classification](#2-stem-cell-types-and-classification) 3. [Regeneration Mechanisms](#3-regeneration-mechanisms) 4. [Tissue Engineering and Scaffolds](#4-tissue-engineering-and-scaffolds) 5. [Growth Factor Delivery Systems](#5-growth-factor-delivery-systems) 6. [Clinical Applications](#6-clinical-applications) 7. [Regulatory Requirements](#7-regulatory-requirements) 8. [Implementation Guidelines](#8-implementation-guidelines) 9. [Safety Protocols](#9-safety-protocols) 10. [References](#10-references) --- ## 8. Implementation Guidelines ### 8.1 Required Components Any WIA-BIO-020 compliant system must include: 1. **Cell Source Management**: Track origin, passage, characterization 2. **Differentiation Protocols**: Standardized, validated methods 3. **Quality Control**: Real-time monitoring and testing 4. **Growth Factor Calculator**: Optimize dosing and timing 5. **Scaffold Designer**: Material, porosity, mechanics optimization 6. **Clinical Tracker**: Patient outcomes and safety monitoring ### 8.2 API Interface #### 8.2.1 Calculate Regeneration Rate ```typescript interface RegenerationRequest { tissueType: 'cardiac' | 'neural' | 'bone' | 'cartilage' | 'skin'; cellDensity: number; // cells/ml timeFrame: number; // days growthFactors: string[]; } interface RegenerationResponse { rate: number; // cells/day recoveryPercentage: number; timeToComplete: number; // days feasibility: 'high' | 'medium' | 'low'; } ``` #### 8.2.2 Assess Cell Survival ```typescript interface SurvivalRequest { cellType: string; viableCells: number; totalCells: number; cultureConditions: string; } interface SurvivalResponse { survivalRate: number; // 0-100% viability: 'excellent' | 'good' | 'fair' | 'poor'; recommendations: string[]; } ``` #### 8.2.3 Design Scaffold ```typescript interface ScaffoldRequest { tissueType: string; material: string; porosity: number; // 0-1 size: number; // cm³ mechanicalRequirements: { youngModulus?: number; // MPa or GPa compressiveStrength?: number; }; } interface ScaffoldResponse { design: { material: string; dimensions: { width: number; height: number; depth: number }; poreSize: number; // μm porosity: number; degradationTime: number; // months }; mechanical: { youngModulus: number; tensileStrength: number; compressiveStrength: number; }; biocompatibility: 'excellent' | 'good' | 'acceptable'; } ``` ### 8.3 Data Formats #### 8.3.1 Cell Characterization ```json { "cellType": "iPSC", "passage": 15, "markers": { "OCT4": 0.95, "NANOG": 0.92, "SSEA4": 0.94 }, "viability": 0.89, "karyotype": "46,XY", "mycoplasma": "negative", "doubling_time_hours": 24 } ``` #### 8.3.2 Tissue Regeneration ```json { "tissue": "cardiac", "patient_id": "P12345", "baseline": { "ejection_fraction": 0.35, "infarct_size_cm2": 15 }, "post_treatment": { "ejection_fraction": 0.42, "infarct_size_cm2": 10, "vessel_density": 320 }, "improvement_percentage": 20 } ``` ### 8.4 Error Handling Standard error codes: | Code | Meaning | Action | |------|---------|--------| | B001 | Cell contamination detected | Discard culture, decontaminate | | B002 | Low viability (<70%) | Optimize culture conditions | | B003 | Marker expression insufficient | Extend culture, retest | | B004 | Scaffold degradation too fast | Change material or crosslinking | | B005 | Growth factor instability | Add stabilizers, reduce temperature | | B006 | Immune rejection risk | HLA matching, immunosuppression | --- --- ## A.1 Endpoint reference ```http POST /regenerative-medicine/v1/preparations # register cell preparation GET /regenerative-medicine/v1/preparations/{id} # fetch preparation record POST /regenerative-medicine/v1/factors # register growth factor POST /regenerative-medicine/v1/applications # register clinical application GET /regenerative-medicine/v1/audit/{prepId} # audit trail POST /regenerative-medicine/v1/qc-results # contribute QC measurement GET /regenerative-medicine/v1/safety/incidents # adverse-event log WS /regenerative-medicine/v1/cleanroom/stream # cleanroom telemetry ``` Every endpoint follows the discovery convention at `/.well-known/wia-regenerative-medicine`. ## A.2 Preparation-record API `POST /preparations` accepts the Phase 1 §A.1 envelope and returns a stable `prepId`. The endpoint is gated by an institutional credential issued to a clinical-grade cell-therapy facility with the appropriate scope; preparations intended for clinical use require the GMP-facility envelope and the regulatory-classification envelope. Read endpoints expose the per-batch lot-release record and the chain-of-custody graph from donor to administered dose. ## A.3 Quality-control API `POST /qc-results` accepts a quality-control measurement against a preparation record per Phase 1 §A.5. The endpoint accepts the binary measurement payload (immunophenotyping FCS, karyotype image, qPCR plate, potency-assay reading) plus the analyst signature and the calibration-record reference per ISO/IEC 17025. Results in the operator's release-test envelope are gated for release; out-of-spec results trigger an investigation event per the operator's release-control SOP. ## A.4 Adverse-event API `GET /safety/incidents` returns the de-identified adverse-event log filtered by indication, preparation type, and date range, with the FAERS-style narrative summarisation for tracked tumourigenicity / immunogenicity / acute-infusion / off-target-engraftment events. Subject-identifying fields are projected out unless the requesting credential carries the subject-data scope. Adverse events are reported to the controlling regulator per the documented timelines (FDA IND safety reporting per 21 CFR 312.32; EU CTR reporting per Regulation 536/2014; KFDA KGCP equivalents). ## A.5 Cleanroom telemetry WebSocket The cleanroom-stream WebSocket multiplexes per-suite environmental events: HEPA-filter pressure differential, particle-count per ISO 14644 Class A/B/C/D, viable-air-monitor read-back, surface-monitoring read-back, glove-port leak-test status, and the operator-of-record envelope for each shift. Subscribers can filter by suite-id and by event class. The broker emits alarm events on out-of-band readings (particle excursion, pressure-cascade reversal) within the safety-loop's hard time budget. ## A.6 Rate-limit and rights envelope Read endpoints: 100 req/h unauthenticated (read-only on de-identified data), 1000 req/h authenticated, 5000 req/h premium tier. Subject data-access requests follow the GDPR Article 15 protocol with a 30-day SLA; rectification (Article 16) and erasure (Article 17, where applicable) requests follow the documented exceptions for clinical-research records subject to retention obligations. ## A.7 Webhook delivery for QC and adverse-event lifecycle Operators registered as cell-therapy facilities, regulatory inspectors, or partnered Tier-1 contract development and manufacturing organisations (CDMOs) can subscribe to webhook deliveries on QC-result lifecycle events (in-spec, out-of-spec, investigation, closed) and on adverse-event lifecycle events (initial-report, follow-up, closed). Webhook payloads carry the same envelope shape as the API GET response, signed by the WIA tenant key. --- ## Z.1 Glossary, conformance, governance A companion glossary at `https://wiastandards.com/regenerative-medicine/glossary/` expands every term used throughout this Phase. The conformance test suite at `https://github.com/WIA-Official/wia-regenerative-medicine-conformance` walks every endpoint and protocol exchange. The reference container at `wia/regenerative-medicine-host:1.0.0` ships every regenerative-medicine envelope and endpoint with mock data so integrators can exercise the contract before wiring real backends. The companion CLI at `cli/regenerative-medicine.sh` ships sample envelope generators with no dependencies beyond `jq` and POSIX shell. ## Z.2 Cross-standard composition (recap) This Phase composes with WIA-OMNI-API for credential storage, WIA-AIR-SHIELD for runtime trust list, WIA-SOCIAL Phase 3 §5 for federation handshake, WIA-INTENT for workload intent declaration, and (where personal data is processed) WIA Secure Enclave for sealed-data envelopes. The composition lets one host running multiple WIA family standards reuse one identity, one signing key chain, and one audit transport rather than maintaining N parallel implementations. ## Z.3 Implementation runbook A first implementation typically follows: stand up the reference container; run the conformance suite against it end-to-end; replace the mock backend with a real backend one endpoint at a time; wire audit-log replication out to the operations sink; onboard a single trusted peer for federation; expand to multiple peers; promote to production with the warning-envelope subscription enabled and the runbook in §Z.5 followed. ## Z.4 Backwards-compatibility promise Within the 1.x line, every Phase 1 envelope shape, every Phase 2 endpoint, and every Phase 3 protocol exchange MUST remain reachable and MUST continue to honour the documented status codes and content shapes. Hosts MAY add optional fields and new envelopes; hosts MUST NOT remove existing ones. Breaking changes ride a major version bump with a 12-month deprecation window per IETF RFC 8594 and 9745 and require a two-thirds Committee vote. ## Z.5 Closing implementer note This Phase fits inside the WIA Standards four-Phase architecture: Phase 1 envelopes are the wire-format contract; Phase 2 surfaces them through HTTPS; Phase 3 wraps them in protocol exchanges that cross trust boundaries; Phase 4 integrates with the broader ecosystem. Regenerative-medicine deployments that follow this layering inherit the per-Phase conformance gates and the cross-standard composition behaviour described in Z.2. 弘益人間 — Benefit All Humanity.