If you’ve been keeping up with our blog, then you know how special umbilical cord-derived stem cells are. Cord blood and cord tissue are packed with a variety of cells, all with their own unique properties. Mesenchymal stromal cells found within umbilical cord tissue (UC-MSC) have distinctive characteristics that make them a desirable subject of study. These cells are readily available, lack exposure to environmental toxins (due to their naivety), and multiply at a higher capacity than MSCs from other sources. What makes them even more appealing is their immunomodulatory, regenerative and anti‐inflammatory capabilities. But, did you know? These cells’ combined abilities create an ideal scenario for yielding beneficial treatment effects in patients suffering from COVID‐19 induced acute respiratory distress (ARDS) and similar respiratory conditions.
MSCs are sourced from bone marrow, peripheral blood, adipose tissue, amniotic fluid and umbilical cord tissue. They have been used in clinical trials to treat other conditions characterized by hyper-inflammatory immune responses, such as autoimmune disease and type 1 diabetes. To that end, researchers rallied to explore possible COVI9-19 management and treatment options through the use of MSCs. In April of 2020, the U.S. Food and Drug Administration (FDA) approved MSC treatments for seriously ill COVID-19 patients as an “expanded access compassionate use.” Currently, there are over 70 MSC-related clinical trials for COVID-19 registered at the NIH ClinicalTrials.gov website. We are particularly interested in the 14 trials involving the use of umbilical cord tissue-derived cells to treat distinct symptoms of COVID-19.
Can Umbilical Cord Tissue Cells Treat Symptoms of COVID-19?
One such Phase 1/2a clinical trial was completed by Dr. Camillo Ricordi and his team at the University of Miami. The study results are published in the Journal of Translational Medicine and describe findings from 24 patients hospitalized with COVID-19 who developed severe acute respiratory distress syndrome (SARS). The double-blind study treated patients who were infused with either UC-MSCs or a placebo. Findings revealed the following:
- “Two intravenous infusions of umbilical cord mesenchymal stem cells (UC‐MSCs), at a dose of 100 million cells per infusion, given 72 hours apart, are safe in COVID‐19 patients with acute respiratory distress syndrome.
- The UC‐MSC treatment group experienced fewer serious, adverse events compared with the control group.
- UC‐MSC treatment was associated with a significant decrease in a set of inflammatory cytokines involved in the COVID‐19 ‘cytokine storm.’
- UC‐MSC treatment was associated with significantly improved patient survival and time to recovery.
- Strong support for further investigation is needed in a larger trial designed to establish efficacy.”
Dr. Ricordi likens UC-MSCs’ homing ability to migrate to damaged cells to the following, "It's like smart bomb technology in the lungs to restore normal immune response and reverse life-threatening complications.” The fact that MSCs can differentiate into other cell types to repair injured sites, specifically in the lungs, has become the basis for other similar clinical trials.
Two New UC-MSC COVID-19 Trials at Duke
Cryo-Cell’s Medical Director, Dr. Joanne Kurtzberg and her research team at The Marcus Center for Cellular Cures at Duke University School of Medicine are currently conducting two major studies: MASC (Phase 1/2) & MISTIC (Phase 1) to treat, respectively, COVID-19 related Acute Respiratory Distress Syndrome (ARDS) and COVID-19 associated Multisystem Inflammatory Syndrome in Children (MIS -C).
The MASC pilot study is expected to finish in July of 2022. It involves 50 participants treated with three consecutive infusion doses of allogenic human cord tissue mesenchymal stromal cells (hCT-MSC) to test the safety and preliminary efficacy. The key secondary endpoints will measure 28-day survival, the number of days from hospitalization to discharge or rehab, and the number of days requiring mechanical ventilation.
The MISTIC multi-center pilot study will determine the safety of intravenous infusion of hCT-MSCs in six children with MIS-C, with a completion date set for February 2022. Participants will be followed up to 90 days after infusion administration to monitor for any adverse events. The secondary endpoints will uncover 28-day survival, inotropic support (i.e., the need for medicine to support heart contraction), days to hospital discharge, and duration of ICU stay.
Banking for the Realities of Today and Tomorrow
We feel this unprecedented pandemic has undeniably changed the world as we know it. Through these two ongoing studies, which are subject to our licensing agreement with Duke University, we hope to be able to heal many patients that suffer from life threatening conditions relating to COVID-19. As these cord tissue-related trials progress, and once these cellular treatments are deemed effective, we expect these treatments to become eligible for Expanded Access Protocol (EAP).
Continue to follow us for updates on the status of these cord tissue-related clinical trials and other exciting trials concerning cord blood. We are on the verge of game-changing research advancement. There has never been a better time to bank your baby’s umbilical cord-derived stem cells! The possibilities for future cellular therapies and access to these treatments will continue to evolve; parents who choose to store will be at the fore of these innovations. If you are interested in learning more about the benefits of cord blood and cord tissue, we invite you to join us for one of our virtual seminars!