FDA Regulation

Stem Cell Recruitment™(SCR), Stem Cell Recruitment Therapy™(SCRT), SCR Facial™, SCR Facelift™ and SCR Hair Regrowth™ are trademarks of Russell Health, Inc. Russell Health’s Stem Cell Recruitment™ products are FDA-compliant and sourced from the rich Wharton’s Jelly layer of the umbilical cord and amniotic fluid and amnio tissue from healthy, full-term donors. 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.

Tissue Quality and Safety

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.

Disclaimer

Stem Cell Recruitment™(SCR), Stem Cell Recruitment Therapy™(SCRT), SCR Facial™, SCR Facelift™ and SCR Hair Regrowth™ 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™, SCR Facelift™ and SCR Hair Regrowth™ 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.