Professional Statements and Societal Positions Guidelines
The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.
Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in 'Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.
American Academy of Pediatrics
The American Academy of Pediatrics issued a position statement in 2017 concerning cord blood banking and selection, but the statement contained no discussion of ex vivo expansion.
National Comprehensive Cancer Network
Current National Comprehensive Cancer Network (NCCN) guidelines on acute lymphoblastic leukemia (v1.2023), acute myeloid leukemia (v3.2023), B-cell lymphomas (v4.2023), chronic myeloid leukemia (v2.2023), myelodysplastic syndromes (v1.2023), Hodgkin lymphoma (v2.2023), or guidance on hematopoietic stem cell transplantation (v1.2023) do not provide recommendations on the use of omidubicel or ex vivo expansion of cord blood more generally.
American Society for Transplantation and Cellular Therapy
The American Society for Transplantation and Cellular Therapy published guidelines on the indications for hematopoietic cell transplantation and immune effector cell therapy in 2020; these guidelines did not provide recommendations on the use of omidubicel or ex vivo expansion of cord blood.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 10.
Table 10. Summary of Key Trials
|Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies a
|Long Term Follow Up Protocol for NiCord(R)/CordIn (Omidubicel) Patients a
|Stem Cell Transplantation With NiCord(R) (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS a
|Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome
NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.