Regenerative Medicine Course Outline

  • Platelet & Mesenchymal Stem Cell Biophysiology

    • Cellular biology of platelets: activation mechanism, α-granule biogenesis, growth factor activity (VEGF, PDGF, TGF-β, IGF, etc.)

    • Hemostatic vs regenerative signaling pathways.

    • Cellular biology of Mesenchymal stem cell (MSC): niche dependence, immunomodulation, osteogenic vs chondrogenic pathways

    • Mechanotransduction and microenvironmental cues in tendon, ligament, cartilage, and bone healing.

    • Evidence-based literature review: current foot & ankle PRP and BMAC outcomes.

  • Office-Based PRP Protocols for Tendinous, Ligamentous, and Joint Injuries

    • Clinical indications: Achilles tendinopathy, plantar fasciopathy, peroneal tendonitis, forefoot/midfoot arthritis.

    • Preparation protocols: leukocyte-rich vs leukocyte-poor PRP.

    • Injection techniques: ultrasound-guided vs palpation-guided approaches.

    • Pre-procedure hydration and patient optimization protocols

    • Post-procedure rehabilitation guidelines

    • Outcome tracking and registry participation.

  • PRP-Assisted Wound Care Protocols for Chronic Ulcers

    • Pathophysiology of Chronic Wounds

    • PRP application methods: topical gel, peri-wound injection, combination with skin substitutes (ADM/dHACMs)

    • Protocol standardization: number of applications, frequency, endpoints.

    • Clinical case series: PRP in neuropathic and venous ulcers.

    • Cost-benefit analysis for wound care practices.

  • Peripheral Venipuncture Training for PRP Collection

    • Vein anatomy (median cubital, cephalic, basilic)

    • Order of draw (CLSI guidelines)

    • Standard venipuncture step-by-step

    • Vein selection, tourniquet technique, aseptic preparation.

    • Needle selection and troubleshooting (small caliber veins, repeat sticks)

    • Hands-on workshop: practice on models, transition to live supervised draws.

    • Prevention and management of complications (hematoma, vasovagal syncope).

  • Overview of Insurance-Reimbursable CPT Codes vs Cash-Pay Offerings

    • CPT 0232T (PRP injection): non-covered services, cash-pay structuring

    • HCPCS G0465/G0460 (Autologous PRP for diabetic/non-diabetic wounds):

    • CPTs 38220 (bone marrow aspiration): usage in elective foot & ankle procedures vs cash-pay structuring

    • Graft/biologic billing examples: cellular/tissue products, wound dressings.

    • Documentation requirements to reduce audit risk.

    • Ethical considerations in pricing and patient access.

  • Elective and Reconstructive Procedures

    • Indications: nonunions, arthrodesis augmentation, osteochondral lesions of the talus, cavus/revision deformity correction.

    • Aspiration technique: iliac crest vs tibial harvest sites.

    • Delivery techniques: direct injection, scaffold seeding, graft soaking.

    • Integration with internal fixation and biologic adjuvants.

    • Surgical case reviews with intraoperative videos.

  • Centrifugation Parameters and Considerations

    • Principles of centrifugation: relative centrifugal force (RCF) vs RPM.

    • Comparative review: fixed-angle vs swing-bucket rotors.

    • Platelet yield optimization: single-spin vs double-spin protocols.

    • Variables affecting MSC yield: aspiration depth, volume, anticoagulant selection.

    • Commercial Device Comparison and Selection Criteria

  • FDA & Regulatory Oversight

    • FDA Section 361 HCT/P guidance: minimal manipulation and homologous use.

    • OHRP & IRB issues in investigational use.

    • CMS perspectives and coverage updates.

    • State medical board compliance and malpractice considerations.

    • Best practices: informed consent, patient registries, adverse event reporting.

  • Infection Control & Safety

    • OSHA standards, bloodborne pathogens, universal precautions

    • Hand hygiene and PPE

    • Sharps handling, disposal, and post-exposure protocol

  • Capstone Session

    • Case-based discussions: choosing PRP vs BMAC vs alternative biologics.

    • Mock patient consultations with coding/consent documentation.

    • OSCE-style skills check: venipuncture, ultrasound-guided injection, centrifuge setup.

    • Compliance audit simulation: chart review for regulatory readiness.