Physician-led care.
MSO-supported delivery.
RegenBio Care is a regenerative-medicine platform that pairs licensed physicians with the non-clinical infrastructure required to deliver measurable, longitudinal patient outcomes, at scale, with clinical guardrails, and inside a compliant data architecture.
Section 351(a),
in plain English.
Human Cellular and Tissue-Based Products (HCT/Ps) regulated under Section 351(a) of the Public Health Service Act require FDA pre-market review and approval — distinct from the more permissive 361 pathway used for minimally manipulated, homologous-use products.
RegenBio Care's structured clinical research programs operate within the 351(a) framework. Investigational products are delivered under appropriate IND/IDE coverage, with informed consent reviewed and approved by an Institutional Review Board (IRB) before any patient enrolls.
Standard regenerative-medicine services delivered through the physician network — peptide protocols, MSC therapies under applicable exemptions, and adjunct modalities — sit alongside research programs and follow each physician's licensure and standard of care.
Four principles that shape every decision.
- 01
Physicians lead.
Clinical decisions stay with the licensed physician of record. The MSO provides workflow, tooling, and engagement — not medical judgment.
- 02
Outcomes get measured.
Patient-reported outcomes, vitals, adherence, and safety events get captured continuously and structured into the FHIR record.
- 03
Compliance is the floor.
BAAs across every vendor, audit logs on every read and write, PHI scrubbing on observability, role-scoped access in every UI.
- 04
Research, when patients consent.
Trial participation is opt-in, IRB-reviewed, and clearly separated from standard care. No patient is enrolled without explicit informed consent.