Traditional Medicine Has Come A Long Way

But It Also Has Its Shortcomings

• 81,083 people in the U.S. died in 2023 from opiate related overdose. ₁
• According to available data, the average number of adverse drug events per year in the U.S. is 4,500,000, and in 2022, 175,000 people died in the U.S. from adverse drug reactions. _2,3
• Although corticosteroid injections producing short-term reduction of pain and swelling, they have been proven to accelerate joint degeneration, osteoporosis, nerve damage and can even cause elevated blood sugar and pressure. _3,4,5,6,7
• The Center for Disease Controls has estimated 1,700,000 people, or 5% of hospital admissions per year, get a healthcare related infection (HAI.) ₈

Regenerative Medicine Offers New Hope For
Anti-Aging and Chronic Conditions

Regenerative Medicine: The Origins & History

• Ancient Sumerian, Egyptian, Chinese, Indian and South Americans pioneered medical discoveries like the use of vegetable and mineral concoctions and skin graft procedures for cleansing/debridement of wounds. ₁₀
• The early 1800’s saw a huge expansion in the fields of biology and medicine when scientists revealed that all life depends on chemical reactions that occur within cells and could be reproduced in the laboratory. ₁₀
• The discovery in the early 1900’s that cell division and heritability in the form of a helical, ladder-like structure, called DNA, geared science up for “a whole other ball game.” ₁₀
• Regenerative medicine has grown from activities in the mid-1900’s including surgery (organ transplantation), surgical implants (artificial hips), and sophisticated bio-material scaffolds (skin grafts.) ₁₀
• Following new technologies, cell biologists researched the capabilities of tissues being grown and harvested for transplantation, thus began the era of Tissue Engineering, which led to the field of Regenerative Medicine. ₁₀

The Evolution of Regenerative Medicine

Platelet
Rich
Plasma

Platelet Rich Plasma (PRP) is derived from the patient’s blood, making it reliant on the patient’s age, health, and lifestyle for its results.

Amniotic
Tissues &
Fluids

Amniotic Tissue & Fluids are harvested during healthy, scheduled c-sections and are rich in cytokines, known for their anti-inflammatory properties. Amniotic products are available as acellular or containing stem cells, with acellular amnio being considered non-tumorigenic.

Stem
Cells
(MSC’s)

Stem Cells can be derived from fat, bone marrow, umbilical cord and other sources. Originally thought to replace damaged tissue, we now know that MSC’s utilize exosomes to communicate and deliver proteins to damaged tissue. Depending on their origin, they can grow any tissue, including tumor.

Exosomes

Exosomes are the communication vesicles for MSC’s and are typically derived from collected stem cells. They both communicate with damaged tissue and deliver key “active ingredients” in healing, although most products don’t define their protein contents and can be “hit or miss” on results.

How are Regenerative Protein Arrays Different ?

• Regenerative Protein Arrays (RPA) are the “active ingredients” (cytokines, growth factors, miRNA) from all three layers of the placenta, responsible for growth and healing of brain, nerve, soft tissue, organ and musculoskeletal systems. ₁₁
• RPA contains over 80 different cytokines, growth factors and miRNA versus 40 contained in amnio, Wharton’s jelly, bone marrow, PRP, and cord blood combined. _{11(APPENDIX A)}
• RPA is an acellular, non-biologic product that contains the basic “active ingredients” found in stem cell and exosome products. This eliminates the need for cellular delivery mechanisms; and decreases the potential for a negative reaction, which is possible with cellular products.
• RPA works by “reprogramming” the local environment, reactivating the cellular processes, and returning the body to the homeostasis of pre-puberty, the peak of the body’s ability to heal. ₁₂

All placentas are harvested after healthy, live births, using Current Good Tissue Practices (CGTP’s), at US-based universities and hospitals.

RPA: Patient Safety Comes First

• Regenerative Protein Array (RPA) is only sourced from donors with a 20-year history of no cancer, no systemic disease, and no genetic altering therapies or inoculations (i.e. COVID-19 Vaccination.)
• All donors are screened with lifestyle testing and proven negative for communicable disease via third party, FDA/CLIA certified labs. _{(Appendix C, D)}
• Post-incubation, the product goes through a 4-stage filtering process to remove all cellular tissue, yielding the acellular, non-biologic product you know as RPA.
• The final stage before lyophilization is endotoxin testing, where third party, FDA/CLIA certified labs prove the final product to be “sterile” via meeting the minimum standard of <0.005 EU/mL. _{(Appendix D)}

Is RPA FDA Approved ?

• RPA is produced at FDA registered labs in the United States. _{(Appendix B)}
• All donors, tissue, and final product are tested at third party FDA/CLIA certified labs.
• The FDA classifies RPA as a “cell factor” since it is created through an incubation / emission process and is acellular. Therefore, the product is exempt from 21 CFR 1271 biologic regulations. _{(Appendix E)}
• The FDA oversees all steps of donation, transport, testing, production, sterilization, and packaging, but treats RPA like a nutraceutical, leaving the choice of use up to the treating physician and patient.

What Conditions Have Been Researched And Treated With Regenerative Medicine ?

• Achilles Tendinosis
• ALS
• Alzheimer’s
• Cancer
• Corneal Disease, Cataracts, Glaucoma
• COVID Long Hauler’s
• Dementia
• Disc Degeneration in Spine
• Heart Disease
• Leukemia
• Liver Disease
• Lymphoma
• Lyme Disease
• Lupus
• Meniscus Tear
• Macular Degeneration

• Multiple Sclerosis
• Osteoarthritis (Shoulder, Hip, Knee, Wrist)
• Plantar Fasciitis
• Parkinson’s Disease
• Psoriatic Arthritis
• Rotator Cuff Injuries
• Sexual Health
• Skin Conditions
• Spinal Cord Injuries
• Sports Injuries
• Stroke
• Tendinitis (Elbow, Shoulder, Knee, Wrist)
• Type 1 Diabetes
• Wounds (Injury, Burns, PAD, DVT)
• And more conditions being researched every day!

We Look Forward To Providing You With World Class Care.

Questions ?

References

Appendix A: RPA Proteins (PCR Analysis)

Appendix B: FDA Lab Registration

Appendix C: Donor Communicable Disease Testing

Appendix D: RPA Endotoxin Testing

Appendix E: FDA Regulatory Classification