Med-IQ
Stem Cell Transplantation With Omidubicel, an Ex Vivo Expanded Umbilical Cord Blood Stem Cell Graft: Results of a Phase 3 Randomized, Multicenter Study

Stem Cell Transplantation With Omidubicel, an Ex Vivo Expanded Umbilical Cord Blood Stem Cell Graft: Results of a Phase 3 Randomized, Multicenter Study

Med-IQ Express
Online Course | Specialties: Hematology, Oncology
Released: 5/20/2021
|
Expires: 5/19/2022
|
Max Credits: 0.25
Jump to Education

Faculty
Mitchell E. Horwitz, MD
Professor of Medicine
Director, Adult Blood and Marrow Transplant Program
Duke University Medical Center
Durham, NC
 
Activity Planners
Amy Burdette, PhD
Manager, Educational Strategy & Content
Med-IQ
Baltimore, MD

Jane Frutchey, MS
Managing Editor
Med-IQ
Baltimore, MD

Samantha Gordon, MS
Accreditation Manager
Med-IQ
Baltimore, MD

Amy Sison
Director of CME
Med-IQ
Baltimore, MD

Writer
Edward Allan Racela Sison, MD
Missouri City, TX
 
Learning Objective
Upon completion, participants should be able to:

  • Discuss key data from the first phase 3 study comparing omidubicel with standard, unmanipulated umbilical cord blood transplantation

Target Audience
This activity is intended for hematology/oncology clinicians.
 
Statement of Need
Allogenic hematopoietic stem cell (HSC) transplantation is a potentially curative therapy for high-risk acute hematologic malignancies. However, human leukocyte antigen–matched related donors are available in fewer than one-half of cases. Therefore, finding readily available alternative HSC sources such as umbilical cord blood (UCB) is of great interest. Although UCB transplantation is readily available and associated with lower rates of chronic graft versus host disease, it is associated with low HSC and hematopoietic progenitor cell (HPC) dose, which has been shown to increase mortality in UCB transplantation. Clinical trials are investigating approaches for administering higher doses of UCB-derived HSCs and HPCs, which, in turn, have resulted in shorter times to hematopoietic engraftment. One approach includes using omidubicel, a UCB-derived product that is the result of ex vivo expansion with nicotinamide, a component that is believed to alter the metabolic pathways of HSCs and allow for the expansion of HSCs and HPCs. It is imperative that hematology/oncology clinicians stay up to date with emerging clinical data related to improvements with UCB so they are prepared to apply new approaches to patient care.

Collaborator Statement
This activity was developed by Med-IQ in collaboration with Duke Health.
Med-IQ      Duke Medicine

Accreditation/Designation Statements
Med-IQ is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
 
Med-IQ designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
 
Medium/Method of Participation
This CE activity consists of a 0.25-credit online publication. To receive credit, read the introductory CE material, read the publication, and complete the evaluation, attestation, and post-test, answering at least 70% of the post-test questions correctly.  
 
Initial Release Date: May 20, 2021
Expiration Date: May 19, 2022
Estimated Time to Complete This Activity: 15 minutes

Disclosure Policy
Med-IQ requires any person in a position to control the content of an educational activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines “relevant financial relationships” as those in any amount occurring within the past 24 months that could create a conflict of interest (COI). Individuals who refuse to disclose will not be permitted to contribute to this CME activity in any way. Med-IQ has policies in place that will identify and resolve COIs prior to this educational activity. Med-IQ also requires faculty to disclose discussions of investigational products or unlabeled/unapproved uses of drugs or devices regulated by the US Food and Drug Administration.

Drug/Product Usage by Faculty
Off-label/unapproved drug uses or products are mentioned within this activity. 

Disclosure Statement
The content of this activity has been peer reviewed and has been approved for compliance. The faculty and contributors have indicated the following financial relationships, which have been resolved through an established COI resolution process, and have stated that these reported relationships will not have any impact on their ability to give an unbiased presentation. 

Mitchell E. Horwitz, MD
Fees received for promotional/non-CME activities: CareDx, Equillium, Kadmon, Magenta Therapeutics

Edward Allan Racela Sison, MD
Salary: Covance, Inc., LabCorp, Precision Medical Group
Ownership interest (stocks/stock options – excluding mutual funds): LabCorp, Precision Medical Group, United HealthCare

The peer reviewers and other activity planners have no financial relationships to disclose. 
 
Statement of Evidence-Based Content
Educational activities that assist physicians in carrying out their professional responsibilities more effectively and efficiently are consistent with the ACCME definition of continuing medical education (CME). As an ACCME-accredited provider of CME, it is the policy of Med-IQ to review and ensure that all the content and any recommendations, treatments, and manners of practicing medicine in CME activities are scientifically based, valid, and relevant to the practice of medicine. Med-IQ is responsible for validating the content of the CME activities it provides. Specifically, (1) all recommendations addressing the medical care of patients must be based on evidence that is scientifically sound and recognized as such within the profession; (2) all scientific research referred to, reported, or used in CME in support or justification of a patient care recommendation must conform to generally accepted standards of experimental design, data collection, and analysis.
 
Med-IQ is not liable for any decision made or action taken in reliance upon the information provided through this activity.
 
Contact Information        
For questions or comments about this activity, please contact Med-IQ. Call (toll-free) 866 858 7434 or email info@med-iq.com.

System Requirements

Desktop

Mobile

  • Operating system - Med-IQ supports the current operating system, plus two prior releases:
    • Android (eg, Samsung Galaxy)
    • Apple (eg, iPhone/iPad)
  • Browsers - Med-IQ supports the default browser for the applicable operating system release, plus two prior releases:
    • Android (Chrome)
    • Apple (Safari)

Applications & Software

For technical assistance, please refer to our Support Manual.

Disclaimer
The information provided through this activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a physician relative to diagnostic and treatment options of a specific patient’s medical condition.

Privacy & Confidentiality
Med-IQ is committed to honoring your privacy and protecting any personal information you choose to share with us. For detailed information about our privacy notice, please visit: www.med-iq.com/privacy-statement/.
 
Complimentary CE
This activity is available free of charge to participants.

Copyright
© 2021 Duke University Health System

Abstract

Here are the key takeaways from this activity. Deeper insights and evidence, plus an opportunity to receive credit, are available at the "Continue" button below.

  • One alternative allogeneic HSC source is UCB, which is a readily available source of HSCs
  • Apart from graft availability, additional advantages to UCB transplantation include lower rates of chronic GVHD compared with HLA-matched unrelated bone marrow or HLA-matched related peripheral blood stem cell transplants, potent antileukemic activity, and tolerance to HLA mismatch, even at multiple alleles
  • The main disadvantage of UCB transplantation, especially in adult transplant recipients, is low HSC and HPC dose, which has been shown to be associated with higher morbidity and mortality in UCB transplantation
  • Clinical trials are testing approaches for administering higher doses of UCB-derived HSCs and HPCs, which, in turn, can result in shorter times to hematopoietic engraftment
  • A randomized phase 3 trial was designed to compare standard, unmanipulated UCB transplantation versus omidubicel, a UCB-derived product that is the result of ex vivo expansion with nicotinamide, a component that is thought to alter the metabolic pathways of HSCs and allow for the expansion of HSCs and HPCs
  • Compared with subjects who received standard UCB transplantation, those who received omidubicel experienced faster hematopoietic recovery, fewer early infections, and fewer days in the hospital without an increase in toxicity, suggesting that omidubicel may be an effective alternative to standard UCB transplantation

View reference list.

Click “Continue” to proceed through this activity and/or receive credit.

By clicking "Continue," you confirm that you have reviewed the CME information.

Continue

Unless otherwise indicated, photographed subjects who appear within the content of this activity or on artwork associated with this activity are models; they are not actual patients or doctors.

The information provided through this activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a physician relative to diagnostic and treatment options of a specific patient’s medical condition.

COPYRIGHTED. Republication or redistribution of Med‑IQ content, including by framing, is prohibited without prior written consent. Med‑IQ shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.