FDA Regulation

Stem Cell Recruitment™(SCR), Stem Cell Recruitment Therapy™(SCRT), SCR Facial™ and Vivaderm™ are trademarks of Russell Health, Inc. Russell Health’s Stem Cell Recruitment™ products are minimally manipulated, FDA-compliant and sourced from placental tissue and placental fluid from healthy, full-term donors intended for homologous use. The human allograft products used in these treatments are human tissue products for transplantation. These allografts are processed and distributed in accordance with FDA requirements for Human Cellular and Tissue-based Products (HCT/P) (21 CFR Part 1271), State regulations, and the Standards of the American Association of Tissue Banks (AATB). These allografts are classified by the Food and Drug Administration (FDA) as Human Cell, Tissue and Cellular and Tissue-Based Products (HCT/P) that are regulated solely under section 361 of the Public Health Service (PHS) Act. FDA recognizes that human tissue was designed, or evolved, to perform certain functions in the human body with exquisite safety and effectiveness. As an HCT/P regulated solely under Section 361 of the PHS Act, Russell Health’s Stem Cell Recruitment Therapy™ products are exempt from FDA pre-market review, clearance, and approval from the FDA.

Vivaderm is processed by Aziyo Biologics in state-of-the-art facilities in Northern California. We use cutting-edge technologies that enable us to process our tissues using precise, standardized methods that ensure quality and consistency across our products and services. All Aziyo tissue undergoes rigorous testing before being released for transplant. Aziyo meets or exceeds all industry benchmarks for quality assurance testing and maintains compliance with the appropriate and required regulatory agencies, including the American Association of Tissue Banks® (AATB®) and the U.S. Food and Drug Administration (FDA).

Tissue Quality and Safety

Stem Cell Recruitment™(SCR), Stem Cell Recruitment Therapy™(SCRT), SCR Facial™ and Vivaderm™ products are prepared from a donor determined to be suitable based on the results of screening and testing. The tests for transmissible infectious diseases produced negative results. The names and addresses of the testing laboratories, the listing and interpretation of all required infectious disease tests, and a listing of the documents reviewed as part of the relevant medical records are on file and available upon request. Due to limitations in testing technology, testing and donor screening cannot totally eliminate the risk that human tissue will transmit disease. The donor has been evaluated and has been determined to be suitable for transplantation based on the donor suitability criteria current at the time of tissue recovery in accordance with United States Food and Drug Administration (FDA) regulations, local and state regulations, and tissue bank protocols.All communicable disease testing was performed on this allograft by a laboratory registered with FDA to perform donor testing and certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a and 42 CFR Part 493); or has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services in accordance with those provisions. Donor blood samples taken at the time of tissue recovery were tested for the following:

  • Cytomegalovirus Antibody (CMV Total Ab)
  • Hepatitis B surface antigen (HBsAg)
  • Hepatitis B core total antibody (HBcAb)
  • Hepatitis B Virus (HBV) Nucleic Acid Test
  • Hepatitis C antibody (HCV)
  • Hepatitis C Virus (HCV) Nucleic Acid Test
  • Human Immunodeficiency Virus (HIV) Type 1 and Type 2 antibody
  • Human Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Test
  • Human T-Lymphotrophic Virus (HTLV) Type 1 and Type 2 antibody
  • Rapid Plasma Reagin (RPR) for Syphilis or Serologic Test for Syphilis (STS)
  • West Nile Virus Nucleic Acid-Test (during active mosquito season per FDA Guidance)

This testing is performed by a laboratory registered with FDA to perform donor testing and certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS). BONE BANK ALLOGRAFTS’ Medical Director has determined this donor tissue to be suitable for transplantation. The testing and medical release records are maintained by BONE BANK ALLOGRAFTS.

Vivaderm’s processing preserves mechanical and biologic properties:

• Sterility Assurance Level (SAL) of 10-6 compared to competitors with a SAL of 10-3
• Gamma irradiation proven to inactivate a broad range of viruses1
• Low-dose precision gamma irradiation combined with a low temperature technique protects
the native biological and mechanical properties of the tissue

Disclaimer

Stem Cell Recruitment™(SCR), Stem Cell Recruitment Therapy™(SCRT), SCR Facial™ and Vivaderm™ are trademarks of Russell Health, Inc. The treatments described on this marketing are not considered to be standard of care for any condition or disease. SCR™, SCRT™, SCR Facial™ and Vivaderm™ attempt to utilize acellular, minimally manipulated tissue allografts and are comprised of tissue allograft components intended for homologous use to supplement tissue. SCRT products are classified by the Food and Drug Administration (FDA) as Human Cell, Tissue and Cellular and Tissue-Based Products (HCT/P) that are regulated solely under section 361 of the Public Health Service (PHS) Act. FDA recognizes that human tissue was designed, or evolved, to perform certain functions in the human body with exquisite safety and effectiveness. As an HCT/P regulated solely under Section 361 of the PHS Act, Russell Health’s SCRT products are exempt from FDA pre-market review, clearance, and approval from FDA. Please consult your doctor to see if an amniotic fluid injection is right for you. No medical advice has been offered herein. These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease. Results may vary.