FLORIDA CORD BLOOD COMPANY SEEING SIGNIFICANT IMPROVEMENT IN BONE MARROW ENGRAFTMENT TIMES

October 4, 2018 by Donald Hudspeth
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Located in Altamonte Springs, Cord For Life® Inc. is a local umbilical cord blood bank that specializes in public and private stem cell processing and cryopreservation. Cord For Life® has operated in the Central Florida area since 1993, and to date has processed over 15,000 cord blood units from across the United States. In addition to collecting, processing and banking umbilical cord blood stem cells, the company provides consulting services to help organizations develop and operate high-quality cord blood banks, and offers educational training programs for healthcare professionals.

Recently, Cord For Life® launched its cord blood banking program.  Under this program private clients can store their baby’s cord blood stem cells (CBSC) for future needs or moms-to-be can donate their baby’s cord blood to the general public through the National Marrow Donor Program’s (NMDP) Be The Match® Registry. Public donation, which has no cost to the donor, makes CBSC available to anyone in the world in need of a stem cell transplant to treat over 75 diseases.

The Cord For Life® program utilizes a revolutionary new processing system, branded as PREMIERMAX®, which significantly reduces red cell contamination in the transplant product while recovering an equal or higher number of stem cells (when compared to other automated and traditional methods). PREMIERMAX® also reduces the level of DMSO required to adequately preserve the cells during the freezing process, thereby reducing potential recipient exposure to this sometimes toxic cryoprotectant.

PREMIERMAX® uses 2 unique reagents combined with individual unit Quality Control by highly trained technicians, to produce a superior final transplantation product. The processing reagent is PrepaCyte®-CB, which demonstrates an unrivaled ability to remove red blood cells over any other method on the market today. Red cell reduction reduces the amount of free hemoglobin in the thawed product infused to the recipient, thereby increasing the safety of the infused product. Additionally, PrepaCyte®-CB has shown in clinical trial and independent evaluation to increase the final stem cell population recovered, most significantly in the post-thaw colony forming assay which indicates functionality of the stem cells for engraftment.

The second key reagent in PREMIERMAX® is the freeze media, CryoStor® CS10. CryoStor is specifically designed to protect cells at ultra-low temp e r a t u r e s , unlike traditional cryopreservation reagents. This results in improved cellular transition through phase change from a liquid blood product to the frozen state for long-term storage, and again during thawing prior to infusion. During our validation of CryoStor® CS10, it was demonstrated that a less concentrated amount of the cryoprotectant reagent DMSO could be used in the freezing process while maintaining acceptable cellular functionality post-thaw.

The most important aspect of any change in status quo is the resulting effect of the change. Historically, the lower stem cell dose of a CBSC product when compared to a bone marrow or peripheral blood stem cell collection resulted in a longer time for bone marrow reconstitution (or engraftment). This led to early beliefs that CBSC could only be useful for pediatric patients or small adults. It was also realized that CBSC would typically result in longer periods of non-immunity, resulting in longer hospital stays for the recipient, even though GvHD is typically reduced.

Current data from over 20,000 CBSC transplants worldwide, shows an average time to PMN engraftment (PMN cell count >500 for 2+ days) is 25-27 days. In fact, our own historical data shows a comparable average PMN engraftment time of 21 days for units processed before our change to PremierMax-CBSM. Following our change in processing method, we are currently seeing an average time to PMN engraftment of only 11.33 days. Even more exciting is that independent data from another NMDP member cord blood bank that also uses PrepaCyte®-CB as it’s processing reagent mirrors our data from Cord For Life® (poster abstract to be published at AABB Annual Meeting 22-25 Oct., 2011).

As you can appreciate, a nearly 10 day reduction in the length of hospital stay, especially for a critically ill patient with no immune function, is highly significant. Having a readily available stem cell source product that can rival the engraftment time of marrow or peripheral blood sources, with a reduced risk of GvHD, and a significantly increased HLA-matching potential would create a major shift in the paradigm. Cord blood products have already begun to outpace marrow as a source for stem cell transplantation. With significant results such as these and new, exciting therapies being developed worldwide, the usefulness of cord blood stem cells will only increase over time. As more and more PREMIERMAX® processed CBSC units are transplanted worldwide, Cord For Life® will continue to monitor and analyze the engraftment data. A 2-site joint publication is expected in 2011 to further analyze the significance of the findings over a broader range of CBSC units, diseases, and transplant centers to eliminate other possible factors for the decreased engraftment time. We feel this finding could create a new excitement in the cord blood transplantation industry and provide a remarkable benefit to patients in need of life saving stem cell transplants.

By Donald Hudspeth, BS(CLS), MT(ASCP) and Sara Irrgang, MD, FCAP, FLORIDA MD, September 2011 Edition, pgs 33-34

 

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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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