ALTAMONTE SPRINGS, FL (October 29, 2021) Cord for Life®, a full-service cord blood bank with over 25 years of experience, today announced plans to conduct a clinical trial to treat lower back pain arising from the Sacroiliac Joint (SIJ) using a biological therapeutic derived from umbilical cord blood.
The company has received FDA authorization of an Investigational New Drug (IND) Application for a Phase 1a, open label, dose ranging study to assess the safety, tolerability, preliminary efficacy, and dose effect of its allogeneic individual donor umbilical cord blood-derived stem cell product in patients with lower back pain of the Sacroiliac Joint (SIJ). The Clinical Trial arrangements are being finalized with expectation of an early 2022 enrollment start. The initial trial includes nine patients with lower back pain, who will receive a range of dosing regimens using the company’s PREMIERMAXCB® product. Following injection, patients will be monitored for 12 months.
“Having been involved in the release of over 2,200 cord blood units for transplants, research, and clinical trials, Cord for Life® is excited about the potential for cord blood in therapeutic medicine”, commented Donald L. Hudspeth, BSCLS, MT (ASCP) General Manager and Director of International Projects for Cord for Life®. “We are committed to supporting research that can unlock the role of cord blood in the safe and effective treatment for both chronic and acute conditions that can improve the quality of life for individuals in need.”
PREMIERMAXCB® is a newly developed investigational biological therapeutic derived from umbilical cord blood. The PREMIERMAXCB® product line is ideal for smaller, localized treatments. The PREMIERMAXCB® PLATINUM product contains 1 mL of a cellular and protein mixture, with an average of 30 million nucleated cells, that has demonstrated promising results in early research testing.
Manufactured under cGMP conditions in the company’s state of the art clean room facility, the products are tested to the highest standards for safety, quality, identity, purity, and potency.
PREMIERMAXCB® is currently available for research use only.
About Cord for Life®
Since 1995, Cord for Life® ® has been a leader in cord blood collection, processing and storage. We were the first cord blood bank to accept both private storage and publicly donated cord blood collections from anywhere in the continental United States. Our team of scientists and cord blood banking professionals are leaders in the cord blood collection community who have helped clients around the world successfully launch and grow their organization’s cord blood collections. Our team members are passionate about our mission to Save Lives.
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.
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.
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.
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.