CORD BLOOD AND ADVANCED CELL THERAPY – THE NEXT FRONTIER

April 6, 2020 by Erin
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Traditionally used to treat blood disorders and help restore the immune system following chemotherapy or radiation, stem cells from umbilical cord blood are now being explored for advanced cell therapy.  According to Parent’s Guide To Cord Blood Foundation, there are now at least 60 clinical trials exploring the potential for hematopoietic stems cells (HSCs) from umbilical cord blood to treat neurological conditionsinfections, wounds, diabetes, and stroke.  These and other potential new uses for cord blood could significantly broaden their role in medicine beyond the current 80+ FDA approved treatments. 

 

FDA Oversight

During these exciting times in the evolution of advanced cell therapy, the FDA is taking a leadership role.  They are working diligently to ensure the safety, purity, and potency of these complex new biological products. In the case of stem cells derived from umbilical cord blood, the FDA classifies certain uses as drugs.  This classification applies to treatments of non-related individuals where stem cells perform different basic function(s) in the recipient than in the donor.  The FDA regulates all drugs under strict manufacturing standards for the pharmaceutical industry, known as current good manufacturing practices (cGMP).  These standards apply to advanced cell therapy that are regulated as drugs.

 

Biological products are more complex than traditional drug products made from chemical substances.  The active component(s) in a biological product are more difficult to define than the chemical ingredients in a traditional drug.  As a result, biological products are often defined by their manufacturing processes. As a result, the FDA monitors production from the early stages to ensure the final product turns out as expected. The FDA requires manufactures to thoroughly test, validate, and research any proposed changes to the manufacturing process, equipment, or facilities that could result in changes to the biological product itself. 

 

Transitioning to New Manufacturing Standards

As companies like Cord for Life® prepare to support the commercialization of new advanced cell therapies derived from umbilical cord blood, we are transitioning to these FDA standards. The FDA thoroughly inspects facilities like Cord for Life® to ensure we are strictly following the cGMP requirements.  Should there be any shortcomings in the manufacturing process, the FDA issues a Warning Letter advising the company to make necessary improvements to ensure full compliance.  The FDA gives companies the opportunity to take corrective actions to fully address any deficiencies in the FDA Warning Letter.  This oversight through facility inspections and FDA Warning Letters is critical to the safety and health of patients.   

 

Preparing for the Future of Medicine

Companies can apply for an an Investigational New Drug (IND) or Biological License once they meet the FDA’s cGMP standards.  Companies can ship product across state lines to support important clinical trials and approved therapies once the FDA grants approval.  Cord for Life® is committed to helping advance medicine through stem cell therapy and has worked hard on complying with the standards to ensure the safety, efficacy, and purity required.  As we transition from the FDA standards for cord blood processing to their standards for drug manufacturing, we rely on their guidance and support.

 

References: 

  1. Recruiting Clinical Trials of Cord Blood or Umbilical Cord Tissue, Parent’s Guide to Cord Blood Foundation. 
  1. Frequently Asked Questions About Therapeutic Biological Products, FDA 
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Our purpose is to provide the expectant mothers with information necessary to discover the lifesaving potential of umbilical cord blood.

Copyright Cord for Life 2019. All rights reserved.

Deborah A. Sardone

Ms. Sardone has over 30 years of clinical laboratory experience as a Clinical Laboratory Technologist and Supervisor, including over 25 years with Central Florida Regional Hospital (CFRH). She was Supervisor of Quality Assurance, Safety and Education at CFRH for 11 years, held the positions of Blood Bank Supervisor for 11 years, and Hematology Supervisor for 1 year. She has participated in both sides of the inspection process, serving on the College of American Pathologists Inspection team for CAP Hospital Accreditation in Florida, and assisting in receiving accreditation by The Joint Commission (TJC), American Association of Blood Banks (AABB), and Food and Drug Administration (FDA) through the inspections of the clinical laboratory. Ms. Sardone is licensed by the State of Florida as a Clinical Laboratory Technologist in Immunohematology, Hematology, Serology and Clinical Chemistry. She is a certified Clinical Laboratory Technologist with the American Society of Clinical Pathologists (ASCP). Ms. Sardone serves as Manager of Quality Assurance and Regulatory Affairs at Cord For Life, Inc. overseeing all licensing and regulatory agencies to ensure that the highest quality in all aspects of cord blood collection, processing, and storage is maintained.  Ms. Sardone has been with Cord For Life for over 5 years of dedicated service. Her skills and knowledge in blood banking and quality assurance have enabled her to establish, implement and maintain a superior quality system that meets and exceeds all standards and regulatory requirements for Cord For Life, Inc.

Personal Background:

  • Sardone is a graduate of The City University of New York in Medical Laboratory Technology.
  • Sardone is licensed in Florida as a Clinical Medical Technologist and she is nationally recognized as ASCP Certified.
  • Sardone enjoys photography and dancing.

Donald Hudspeth

Mr. Hudspeth has over 28 years of clinical laboratory experience as a certified Medical Technologist (ASCP), including ten years with the University of North Carolina Hospitals and 18 years with Cord for Life. Mr. Hudspeth is licensed by the State of Florida as a Clinical Laboratory Supervisor in Immunohematology, Hematology, Serology, Clinical Chemistry, Molecular Pathology and Microbiology as well as a Clinical Laboratory Scientist and has completed the AABB Certification in Cellular Therapies through George Washington University.

Mr. Hudspeth is a registered Technologist with the American Society of Clinical Pathologists and a member of the Cord Blood Association. He has also enjoyed teaching Immunology to Clinical Laboratory Science and medical school students at UNC while working in the UNCH clinical labs.  Mr. Hudspeth is an Eagle Scout with 5 palms and has served numerous volunteer positions within the local Scouts BSA Troop and Pack.

Personal Background:

  • Mr. Hudspeth received his Bachelor’s degree in Clinical Laboratory Sciences from the University of North Carolina at Chapel Hill.
  • “Eagle Scout with Five Palms”
  • Avid golfer with a 14 handicap.

Kelli Cable

Ms. Cable has 35+ years – experience in Office, Management, Human Resources, & Customer Service. As the Director of Administration and Client Services, Ms. Cable joined Cord for Life in December 2006, and has assisted in providing more efficient and effective ways to ease the enrollment process, as well as obtaining and establishing excellent customer care during the enrollment and donation period; for our Storage and Donation customers.

Personal Background:

  • Mrs. Cable is married and has two boys.
  • In 1994, Ms. Cable moved to Orlando from Boulder, Colorado.
  • Has a passion for travel and enjoys watching NFL games, cheering on her favorite team, the Denver Broncos.

Sara Irrgang, M.D

During the last two years of Medical School, Dr. Irrgang was in the United States Navy 1915 Ensign Program and completed a clerkship at the Naval Hospital at Charleston, South Carolina as well as a research clerkship at the Naval Aerospace Institute at Pensacola, Florida. Dr. Irrgang completed her four year Pathology residency at Baylor University Medical Center, and her internship at the University District Hospital, Rio Piedras in San Juan, Puerto Rico.

Currently, Dr. Irrgang is Board Certified in Anatomic and Clinical Pathology and licensed in the states of South Carolina, Texas, New Jersey and Florida and she is an Associate Medical Examiner at the District Nine Medical Examiners Office. Dr. Irrgang is a fellow at numerous organizations including; The College of American Pathologists, National Association of Medical Examiners, Florida Association of Medical Examiners, Seminole County Medical Society, and the Florida Medical Society.

Personal Background:

  • Dr. Irrgang received a Bachelor of Science degree in Pharmacy from the University of South Carolina.
  • Attended the Medical College of South Carolina at Charleston where she earned a Medical Doctorate Degree.
  • Dr. Irrgang has a passion for breeding show horses
  • Dr. Irrgang is a 4-H leader in Lake County, Florida
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