This document addresses cord blood banking, which is a process of collecting hematopoietic progenitor stem cells from the umbilical cord and placental blood and cryogenically freezing them immediately after the birthing process. Both malignant and non-malignant diseases, including genetic diseases, may be treated with cord blood hematopoietic progenitor stem cell transplantation.

Note: For additional stem cell transplant information and criteria, see the applicable transplant document:

• TRANS.00023 Hematopoietic Stem Cell Transplantation for Multiple Myeloma and Other Plasma Cell Dyscrasias
• TRANS.00024 Hematopoietic Stem Cell Transplantation for Select Leukemias and Myelodysplastic Syndrome
• TRANS.00027 Hematopoietic Stem Cell Transplantation for Pediatric Solid Tumors
• TRANS.00028 Hematopoietic Stem Cell Transplantation for Hodgkin Disease and non-Hodgkin Lymphoma
• TRANS.00029 Hematopoietic Stem Cell Transplantation for Genetic Diseases and Aplastic Anemias
• TRANS.00030 Hematopoietic Stem Cell Transplantation for Germ Cell Tumors
• TRANS.00031 Hematopoietic Stem Cell Transplantation for Autoimmune Disease and Miscellaneous Solid Tumors
• TRANS.00034 Hematopoietic Stem Cell Transplantation for Diabetes Mellitus

Position Statement

Medically Necessary:

1. The use of umbilical cord blood progenitor cell transplantation is considered medically necessary for selected individuals when all of the following criteria are met:
   1. One or two donor cord unit(s) is used for a single recipient; and
   2. The total nucleated cell (TNC) count is equal to or greater than 2.3 x 10⁷ per kg; and
   3. The umbilical cord blood stem cell unit(s) is used for an allogeneic stem cell transplant for an approved indication and the appropriate stem cell transplant criteria are met.
       
2. Collection and storage of cord blood is considered medically necessary only when an allogeneic transplant is imminent for an identified recipient and the above criteria are met. Storage will only be authorized at centers approved by one of the following:
   1. Foundation for the Accreditation of Cellular Therapy (FACT);
   2. NetCord-FACT;
   3. National Cancer Institute (NCI);
   4. National Marrow Donor Program (NMDP);
   5. AABB (formerly known as American Association of Blood Banks);
   6. California Department of Public Health.

Investigational and Not Medically Necessary:

The use of umbilical cord blood progenitor cell transplantation is considered investigational and not medically necessary when criterion A is not met.

Prophylactic collection and storage of umbilical cord blood is considered investigational and not medically necessary when proposed for an unspecified future use for an autologous stem cell transplant in the original donor or for an unspecified future use as an allogeneic stem cell transplant in a related or unrelated donor.