Coronavirus and the Cord Blood Banking Industry

The literary reference that best fits this topic is the opening sentence of Charles Dickens’ novel, A Tale of Two Cities: “It was the best of times, it was the worst of times, …”  The coronavirus pandemic has brought both good news and bad news to cord blood banks, as well as to the clinical trials that rely on newborn stem cells.

Family cord blood banks are caught between increased consumer desire for their services, versus decreased ability of parents to afford their services.  Around the world, across all social and economic groups, everyone has heightened awareness of health issues. Families are more receptive to the idea of banking their newborn’s cord blood and birth tissue as a form of health insurance.

But, at the same time, the economic disruption resulting from shelter in place orders has temporarily pushed unemployment to levels not seen since the Great Depression¹. At this moment, fewer parents can afford family cord blood banking. Global Cord Blood Corp., the leading cord blood bank in China and the largest family bank in the eastern hemisphere, is forecasting a 19%-29% decrease in new client enrollments during their upcoming fiscal year².

The depth and duration of drops in family banking enrollments will vary from one country to another. One of the two biggest factors is how soon the economy of that country recovers, with consumer employment and incomes returning to pre-pandemic levels. The other big factor is the business models of the family banks: do they recruit parents via on-line marketing or via encounters inside birthing hospitals? All in-person marketing, particularly in hospitals, will be suppressed for some time. The enrollment decline that was forecast by Global Cord Blood Corp. factored in their heavy reliance on recruitment in hospitals, as well as the possibility that fewer births in China will be planned for the year ahead.

Public cord blood banks have been experiencing declining numbers of cord blood transplants for several years now. Annual reports from the World Marrow Donor Association (WMDA) show that the number of cord blood transplants worldwide dropped 31% over the five years from 2013 to 2018³. Due to decreased utilization, many public cord blood banks have stopped collecting new donations.

Against this backdrop of a failing business model, the coronavirus pandemic has brought some relief to public cord blood banks. Suddenly, it is difficult for registered adult donors to travel to a healthcare facility for confirmatory testing and donation. Donated cord blood units are a more competitive graft alternative now, because they are ready and waiting in banks, plus their long-term transplant outcomes rival those of any adult donor graft source. During the month of March 2020, Be The Match shipped 28% more cord blood units than the prior year⁴.  But can this increased utilization of public cord blood units for transplants be sustained?

The HRSA Advisory Council on Blood Stem Cell Transplantation met virtually on 27 April and received a presentation on the challenges and opportunities facing cord blood banking in the era of COVID-19. The presentation was prepared by the cord blood special interest group of the American Society of Transplantation and Cellular Therapy (ASTCT)⁴.  From a public health perspective, there is clearly an ongoing need for cord blood transplants, especially for minority patients. But there are obstacles to patient access. The biggest obstacle is that nearly 80% of United States transplant centers have little or no experience giving cord blood transplants. The special interest group is proposing a demonstration project that can help their colleagues to gain education and expertise in cord blood transplantation.

During this pandemic, most non-essential medical procedures have been put on hold, and this is impacting clinical trials around the world. Many planned trials are not launching. It has become difficult for treatment centers to monitor the patients in ongoing trials, even though monitoring outcomes is crucial for successful trial completion. To some extent patient visits can be replaced with remote monitoring technologies, but currently there is a bottleneck as multiple pharma companies attempt to pivot to those technologies simultaneously^5-7.

Despite the pandemic, CellTrials.org has found that worldwide registrations of new trials in advanced cell therapy are up nearly 30% for the first quarter of 2020⁸. Most of the increase can be attributed to cell therapy efforts to treat COVID-19, and over half of those COVID-19 trials employ umbilical cord MSC⁸. Hence, the pandemic has created a new market for those companies that manufacture MSC products from donated birth tissues. Many of these companies have applied for COVID-19 Emergency Use Authorizations from the FDA⁹ and are partnering with local hospitals to treat COVID-19 patients. There are so many of these new relationships being forged so fast that it is difficult to track them.

It is always true that disruption creates business opportunities, and even a pandemic is not an exception. The challenge for companies involved in the collection, processing, and banking of newborn stem cells is to survive the downsides and take advantage of the new possibilities.

References:

1. Hiltzik M. Could unemployment reach Great Depression levels? Yes, but ...  Los Angeles Times 2020-04-03
2. Investor Relations. Global Cord Blood Corporation Provides Further Update on COVID-19. Press Release. 2020-04-27
3. WMDA. 2018 Annual Report web page Released July 2019
4. HRSA Advisory Council on Blood Stem Cell Transplantation. bloodstemcell.HRSA.gov April 27, 2020 Meeting Summary Notes (not uploaded yet)
5. FDA. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. Guidance for Industry, Investigators, and Institutional Review Boards. FDA.gov March 2020
6. Miseta E. COVID-19 And Its Impact On Clinical Trials. Clinical Leader. 2020-04-10
7. Vaidya M. and Castaneda R. Covid-19: Experts say clinical trials may be affected from enrolment to data analysis. GlobalData Healthcare 2020-03-22
8. CellTrials.org Advanced Cell Therapy Trials Surge Ahead Despite COVID-19 Blog 2020-05-11
9. FDA. Emergency Use Authorizations. web page Last updated 2020-05-08