Umbilical Cord Blood Banking

Research focuses on expanded options for these life-saving cells

When a baby is on the way, expecting parents might spend as much time thinking about how to preserve the infant’s potentially life-saving cells as how to properly install a car seat in the back of the family sedan. Rich in stem cells, a baby’s umbilical cord and placenta-typically discarded shortly after birth-can be collected and stored to treat patients with blood-related illnesses such as leukemia.

Public cord blood banks, such as ClinImmune Labs at the University of Colorado Anschutz Medical Campus, cover the cost of collecting and storing a baby’s cord blood. The donation may be used to rebuild a patient’s hematopoietic system with blood-forming cells. Parents who choose the private route can pay to store the umbilical cord blood for their own child’s future needs.

The human body has several types of stem cells, including the hematopoietic
progenitor cells found in umbilical cord blood and bone marrow. The immature cells are able to reproduce themselves and potentially turn into other types of cells.

“Unlike bone marrow, which could take months to find a match, patients with leukemia can look on the cord blood registry and quickly find a match,” explained Brian M. Freed, PhD, executive director of ClinImmune Labs. “Cord blood is an easier alternative.

Bone marrow and cord blood transplants can be potentially life-saving treatments for more than 70 different diseases, including leukemia, lymphoma, sickle cell disease, aplastic anemia, myelodysplastic syndrome, inherited immune deficiency disorders and inherited metabolic disorders.

Collection & Storage of Cord Blood

There are specific protocols for collecting and storing cord blood in order to ensure sterility and maintain the integrity of the sample. “The process of collecting cord blood is similar to a blood donation,” observed Freed.

To put parents’ fears at ease, it’s important to note that choosing to donate does not affect labor and delivery, and no blood is drawn directly from the baby. The process is safe, free and anonymous for the donating family, according to representatives with Be The Match. The cord blood coordinating center works with all public cord blood banks to list individual cord blood units on the Be The Match Registry, where they are made available to any patient in need of a transplant.

Once the baby is born, the umbilical cord is clamped and cleaned of excess blood so that it’s sterilized and bacteria free, Freed shared. Then the blood sample is collected and placed in a sterile bag to prepare for shipping to a blood bank.

Per Be The Match, the amount of cord blood collected varies. When selecting a unit for transplant, physicians consider the number of blood-forming stem cells in the cord blood unit. A greater number of cells can result in quicker engraftment, and makes it feasible to treat larger-sized patients such as adolescents and adults.

When the lab receives the sample, it’s important to test the mother for viral diseases such as HIV; test the product to make sure it wasn’t contaminated in the collection process; and count the cells and stem cells it contains, Freed told ADVANCE. The labs use human leukocyte antigen (HLA) markers to mark the cord blood as they do with bone marrow.

“Once the blood is shipped to the lab and processed, the sample is frozen at one degree per minute,” Freed said. “With slow freezing, the cells remain alive during the process.”

Stored for Future Use

According to the FDA, cord blood stored for future use by a patient unrelated to the donor is categorized as a drug under the Food, Drug & Cosmetic Act as a biological product under Section 351 of the Public Health Service Act. Before it can be used, cord blood in this category must meet additional requirements and be licensed under a biologics license application (BLA), or subject to an investigational new drug application (IND).

ClinImmune Labs received a license for its stem cell product from the FDA in 2012. “There are only five licensed banks in the United States, so it’s a very limited, highly regulated field,” Freed said. “Having the product licensed reduces the chances that a bad product will get through. Our product has followed all the checks and balances.”

According to Freed, cord blood that sits in the sun too long or is exposed to cold temperatures, for example, could be compromised. “We temperature monitor all of our products,” he said.

Be The Match identifies a diminished amount of blood-forming cells as the most common reason a cord blood unit does not reach the storage phase. If transplant standards aren’t met, then the donor may be asked to donate the cord blood to research to improve the transplant process for future patients and investigate new therapies, or the donation may be discarded.

Current research efforts, such as using multiple units or expanding the number of cells within a single unit, aim to overcome the cell dose limitation to increase the uses of cord blood. According to Be The Match, research will enable more patients to find a matched cell source. In 2014, 41 percent of cord blood transplants facilitated by Be The Match used more than one cord blood unit. Using two cord blood units to increase the number of blood-forming cells is an option for some patients.

Haplo-identical transplants, in which cells are collected from a sibling or parent, and infused along with a cord blood unit, are designed to increase the number of blood-forming cells, much like the double cord transplants, reported Be The Match.

Additionally, clinical trials are actively studying the use of marrow and cord blood to treat other diseases. Other cells can be grown from cord blood cells, which may also expand its possible uses down the line, Freed explained. The cells can be used for wound healing and cartilage repair, for example.

Current trials are studying cord blood for regenerative medicine applications, such as spinal cord injury, and neonatal brain injury applications, such as cerebral palsy. Although not actively involved in these trials, Be The Match is watching outcomes to see if cord blood stem cells can unlock cures for these patients.

Education and awareness can play a large role in increasing the research investments and adoption of cord blood. Because of funding limitations, it’s not currently possible to donate cord blood at every hospital. Additional financial resources are needed to increase opportunities for donation, collection and storage of cord blood units.

Be The Match suggests that states help by building partnerships with existing public cord blood banks and local hospitals in their communities, and by appropriating additional resources for the collection and storage of donated cord blood units.