Covers 21 CFR Part 1271 and cGTP requirements, the distinction between FDA registration and FDA approval, HCT/P classification criteria, minimal manipulation and homologous use standards, and how these regulations shape what a practice can and cannot represent to patients about biologic products.

Reviews how state-level regulations layer on top of federal requirements, including state-specific biologics and tissue laws, board-of-medicine guidance, scope-of-practice boundaries for different license types, and informed consent requirements that vary by jurisdiction. Participants learn how to identify their state's specific rules rather than relying on general statements.

Explains what AATB accreditation means, what tissue establishment standards cover, scope of accreditation versus general registration, chain of custody requirements, donor eligibility and screening criteria, and how to verify that a supplier's accreditation credentials apply to the specific tissue category being purchased.

Walks through the specific products covered by this program — the 25M UCT-MSC vial and the 60B exosome matrix — including their labeled category, regulatory status, composition, manufacturing method (3D bioreactor culturing), and the boundary between what the label supports and what it does not. Participants learn to read and interpret product documentation accurately.

Teaches a framework for evaluating published studies and supplier-provided data. Covers the difference between in-vitro, animal, and human clinical evidence; how to interpret study design, sample size, and endpoints; recognizing overstated conclusions; and understanding what the current evidence base does and does not support for the products in this program.

Hands-on instruction in reading Certificates of Analysis. Covers dual-lab testing methodology, NTA particle counts, sterility and endotoxin results, cell viability data, population doublings, and what each data point means in practical terms. Participants complete a guided COA exercise using real product documentation.

Provides a structured approach to patient consultations involving biologic products. Covers patient selection considerations, how to present product information without overstating evidence, managing patient expectations, discussing the unapproved status of products, and documenting the consultation process. Includes a consultation simulation exercise.

Guides participants through developing their practice's own internal protocols under medical director oversight. Covers documentation standards, protocol elements, review and revision processes, staff training requirements, and why protocols must be developed and owned by the practice rather than adopted from a product supplier. Includes a protocol-development workbook exercise.

Covers the essential elements of informed consent for biologic products, including disclosure of unapproved status, alternative options, risks and limitations, and documentation requirements. Reviews record-keeping practices that support both patient safety and regulatory compliance. Participants evaluate sample consent documents and identify gaps.

Covers product receiving procedures, temperature monitoring, storage requirements (exosome products at −80°C; stem cell vials per lot-specific guide), inventory management, chain of custody documentation, and what to do when a temperature excursion or delivery issue occurs. Participants complete an operations checklist for their own practice.

The capstone module. Participants complete a structured readiness assessment covering regulatory understanding, product knowledge, consultation and consent processes, protocol documentation, operations procedures, follow-up framework, and event-reporting plans. Identifies remaining gaps before the practice moves to implementation. Results are reviewed with the training team.

UCT-MSC

Umbilical cord tissue-derived mesenchymal stem cells (UCT-MSC). Wharton's jelly tissue source from an AATB-accredited establishment with this tissue category within scope of accreditation. Cryopreserved vial containing 25 million viable cells.

Not FDA-approved for any specific use. Use is individualized under the direction of the treating physician. Patients should consult their primary care provider.

Exosome Matrix

Topical cosmetic exosome matrix containing 60 billion NTA-verified extracellular vesicles per 1 mL vial. Manufactured using 3D bioreactor culturing technology. Dual-lab COA verified.

Topical cosmetic product. Not a drug, biologic, or FDA-approved therapeutic agent. For external topical cosmetic use only.

Tier 1

Virtual Academy

✓  Eleven live Zoom modules

✓  Participant workbooks & exercises

✓  Readiness assessment

✓  Training Completion Records

✓  Implementation review

✓  30-day follow-up

Tier 2

Virtual Academy Plus

✓  Everything in Tier 1

✓  Private sessions with Jeff & Dr. Buchanan

✓  Document review

✓  Consultation simulation

✓  30-, 60-, and 90-day follow-up calls

Tier 3

On-Site Integration Intensive

✓  Everything in Tier 2

✓  On-site workflow review

✓  In-person simulations

✓  Gap analysis

✓  Post-visit follow-up

No patient care is performed during on-site visits.

◆  Participant workbook

◆  Regulatory reference guide

◆  Product reference cards

◆  COA interpretation exercise

◆  Consultation framework

◆  Patient-selection worksheet

◆  Protocol-development workbook

◆  Operations checklist

◆  Follow-up framework

◆  Readiness assessment

◆  Training Completion Records

◆  Ongoing implementation support

Licensed medical professionals — physicians (MD, DO), nurse practitioners, physician assistants — and their clinical and operations staff who will be involved in evaluating, implementing, or managing a biologics program within the practice.

The full eleven-module program is delivered across scheduled live sessions. Total time commitment depends on the tier selected — Tier 1 includes the core modules, while Tiers 2 and 3 add private sessions, simulations, and extended follow-up. Contact us for the current session schedule.

We recommend including the medical director or supervising physician, treating providers who will consult with patients, and operations or clinical staff responsible for product handling, documentation, and scheduling. The regulatory and evidence modules are particularly important for decision-makers; the operations modules are essential for staff managing logistics.

Participants receive a Training Completion Record documenting the modules completed and the assessment results. This is not a medical certification, board certification, licensure, or clinical credentialing. The completion record reflects participation in an education and implementation-readiness program.

Session recordings may be available for review within your training cohort. This program is designed for live participation with interactive exercises, so attendance at live sessions is strongly encouraged. Contact us for current recording availability and access policies.

The participant workbooks and regulatory reference materials are designed to support internal staff training. New team members can be onboarded using these resources under the direction of a provider who completed the program. Additional training sessions or refresher modules can be arranged through the partner team.

No. This program covers regulatory education, product evaluation, patient consultation, protocol development, operations, and readiness assessment. It does not include hands-on procedural training, clinical credentialing, or supervision of patient care. Procedural training and clinical competency remain the responsibility of the practice and its medical director.

The program provides a protocol-development workbook with frameworks and guiding questions — not prescriptive templates. Protocols must be developed, reviewed, and owned by the clinic under its medical director's oversight. Stem Nova provides the educational framework; the medical decisions and protocol content are yours.

Stem Nova provides product documentation, regulatory education, and implementation guidance. We do not provide medical advice, clinical recommendations, or treatment protocols. Questions about patient care, dosing, routes, indications, or clinical decision-making should be directed to the practice's medical director and independent medical advisors.

Yes. Tier 1 includes a 30-day follow-up; Tiers 2 and 3 extend to 30-, 60-, and 90-day check-in calls. All tiers include access to updated product documentation, COAs, and regulatory reference materials as they become available. Additional support or refresher sessions can be arranged through the partner team.