Answers to Questions about the Coronavirus Pandemic
and the Banking of Cord Blood and Birthing Tissues

Issued:  April 8, 2021

Medical scientists are learning more every day about the coronavirus. Among the questions about the pandemic and the COVID-19 disease are some pertaining to umbilical cord blood and perinatal tissues.

Answers to Questions about Banking during Coronavirus

The Cord Blood Association (CBA) has prepared known answers for commonly asked questions. The association represents cord blood and perinatal research investigators, clinicians and banking personnel around the world.

Are the cord blood units stored in public and private banks prior to the coronavirus pandemic safe from contamination?

Yes. The bag in which a cord blood unit is frozen must pass container integrity testing per FDA regulations. The bag is overwrapped with a second bag (like a “seal-a-meal”) to provide an extra layer of covering. The unit is then frozen and stored under liquid nitrogen, a way to maintain the cells at an ultra-cold temperature. 

Can cord blood and perinatal tissues be safely collected in births during the current pandemic?

Yes.  Even in normal times, mothers are routinely tested and screened to determine if they might have any disease that would affect the collection of their baby’s cord blood or perinatal tissues. Screening through medical histories for risk of COVID-19 has also been implemented by all banks.

Are banking services available during the current pandemic?

Cord blood banks are essential services that are continuing to operate during social distancing and shelter-in-place orders. Yet some individual banks may be experiencing staffing and economic impacts similar to other organizations and businesses. To know what services are currently available, parents should talk to their health care provider or the hospital where they expect delivery of their baby.

Has the U.S. Food & Drug Administration issued any official guidances for cord blood banking during the pandemic?

Yes.  The FDA issued Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the COVID-19 Pandemic in January 2021. The agency recommends that the following three questions be added to donor screening questionnaires:

In the 28 days prior to HCT/P harvest, has the donor (the mother for cord blood):

  • Cared for, lived with, or otherwise had close contact with individuals diagnosed with or suspected of having COVID-19 infection?
  • Been diagnosed with or suspected of having COVID-19 infection?
  • Had a positive diagnostic test (e.g., nasopharyngeal swab) for SARS-CoV-2 but never developed symptoms?

The FDA specifically stated that it does not recommend using laboratory tests to screen asymptomatic HCT/P donors. The agency also specified that, based on information available at this time, those who received non-replicating, inactivated, or RNA-based COVID-19 vaccines are not precluded from donating or storing HCT/Ps.

FDA also issued new guidance Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency in January 2021. In this guidance, FDA states that “in accordance with quality risk management principles, drug manufacturers are expected to prevent or mitigate potential adverse effects on the safety and quality of their products. To minimize the risk of SARS-CoV-2 transmission through cellular therapy and gene therapy (CGT) products, considerations include, but are not limited to, the assessment of donors, cellular and tissue source materials, manufacturing processes, manufacturing facility control, product testing, and the number of subjects that can be treated with the product. The FDA expects that each establishment will conduct a risk assessment of these factors and that the risk assessment be approved by the manufacturer’s quality management systems.” 

Can COVID-19 be transmitted from a pregnant mother to her fetus during pregnancy?

There are reports of more than 2,059 published cases of mothers who contracted COVID-19 during pregnancy. There were 2,015 live births, 42 abortions, and 21 still births in this group. Preterm births occurred in 23% of the pregnancies. Six percent of women required admission to an intensive care unit and 28 died. There were also 10 neonatal deaths. There were 163 cases in which amniotic fluid, placenta and/or cord blood was analyzed for the SARS-CoV-2 virus and 10 were positive (8/67 placentas; 1/54 amniotic fluid; and 1/42 cord blood samples). Sixty-one infants tested positive for SARS-CoV-2 at birth and 4/92 examined samples of breast milk were positive for SARS-CoV-2 (Rodriquest C, Baia I, Dominques R and Barrow H. Frontiers in Public Health, Volume 8:1-13, 2020).

Can COVID-19 be passed to a patient in a cord blood transplant?

There are no known reports of coronavirus transmission in a transplant. In fact, there has never been a documented case in which any kind of respiratory virus has been transmitted to a patient by implantation, transplantation, infusion or other transfer of cells or tissues.  

Is cord blood a possible alternative in bone marrow transplants if a live donor is not available?

Yes.  Banked unrelated cord blood has been used for many patients whose adult donors are unavailable, which can easily happen during a coronavirus pandemic. A donor may not be available because of exposure to a virus or lack of a functioning center for donation due to repurposing of medical facilities to care for COVID-19 patients.

Because cord blood units are safe and quickly available, the major transplant donor registries are recommending that a back-up cord blood unit be identified for all patients undergoing workup for blood or marrow transplant.

Might cord blood play a role in the search for a COVID-19 treatment?

That is a possibility, but as yet there is no clear answer to the question. Cord blood, cord tissue and placenta tissue are being studied to determine whether they can be used in the manufacture of cell therapies to fight the COVID-19 virus.

For example, preliminary studies are showing that a cell manufactured from these tissues called mesenchymal stromal cells (MSCs) could help patients with acute respiratory distress syndrome (ARDS), which often is a fatal complication of COVID-19. Preliminary data in testing with patients are encouraging, and clinical trials are under way in Asia, Europe and the United States.

Where is more information about pregnancy during the coronavirus pandemic?

The U.S. Centers for Disease Control and Prevention (CDC) has published answers to questions expecting parents may have about pregnancy and breastfeeding during the coronavirus pandemic.

Additional guidelines for pregnancy during the coronavirus pandemic are offered by the American College of Obstetricians and Gynecologists (ACOG).