COVID-19 and Newborn Stem Cell Trials Gain Momentum

Author: Kate Brown, Ph.D., Scientific Director, Research and Development

The COVID-19 pandemic continues to be a worldwide threat that tests the capacity of health care systems around the globe. But the potential for cell-based interventions, including those reliant on cord tissue mesenchymal stem cells (MSCs), to make a meaningful difference in the outcomes of patients with severe manifestations of COVID-19 has garnered huge interest from the scientific and medical communities as well as the mainstream press.   

Recently, we outlined some of the clinical trials that would help determine if certain types of stem cells are safe and effective in treating COVID-19 complications. We focused on many bits of evidence, all of which predate the emergence of COVID-19, describing why researchers are looking at MSCs as part of a COVID-19 intervention in patients with pneumonia and acute respiratory distress syndrome (ARDS). 

Now, we have a few updates! In light of new results from early-stage clinical investigations, let’s revisit the ways in which MSCs could play a role in reducing the devasting impact of COVID-19. 

A hyper-immune response to COVID-19 

One of the primary causes of rapid clinical deterioration in patients with severe COVID-19 is the damage to lung tissue resulting from an over-reactive immune response.1 

The question then becomes, what tools do we have in our toolbox to modulate and control the immune dysregulation in patients with severe COVID-19 complications?  

Fortunately, early case reports and small clinical trials suggest that MSCs may be helpful in treating patients with COVID-19.4-6 For example, researchers at a hospital in China’s Hubei province published the results of a controlled, open-label pilot clinical trial that treated patients with severe COVID-19 using MSCs from cord tissue.7  

What did they discover? 

  • Faster improvements in health 
  • 0% mortality rate compared to a 10% mortality rate in patients who did not receive MSCs 
  • Reduced inflammation 
  • Decreased levels of immune cells 6 

Although it was limited in size, the study’s results provide important clinical evidence that cord tissue MSCs may modulate the immune system to improve lung inflammation in patients with severe respiratory COVID-19 complications. 

Our response to the COVID-19 crisis 

Based on the studies that showed the anti-inflammatory and immune-modulatory effects of MSCs, we anticipated that a consistent supply of starting material for cell-based clinical trials (and, hopefully, treatments) would be crucial for combating the virus. 

In April, we received approval to build a repository of cryopreserved umbilical cord tissue donated under informed consent to facilitate COVID-19 research, including for clinical and pre-clinical studies. 

Besides collecting donations and building the COVID-19 cord tissue repository, we began discussions with NantKwest, Inc., a clinical-stage immunotherapy company.  

In August, we announced our partnership with NantKwest, in which we will provide cord tissue MSCs cryopreserved with the same standard procedures we use for our private newborn stem cell clients. NantKwest will then multiply the MSCs and prepare them for use in an early-stage trial for severe COVID-19 patients with respiratory complications! 

What’s next for the research? 

Worldwide, researchers are racing to develop novel vaccines, identify new potential therapies (including cell-based approaches), and evaluate whether existing pharmaceuticals can slow down the progress of COVID-19 in patients. FDA-approved frameworks for these clinical trials are a huge step toward protecting patient safety while advancing the research. 

We’re definitely eager for the results of these cell-based clinical trials, hopeful and confident that the promising evidence that MSCs regulate damaging immune and inflammatory responses in other conditions will continue to hold true for severe COVID-19 respiratory complications. 

As always, we’ll keep you posted as the science moves forward. Keep on the lookout for our next article, and don’t forget to share with friends and family! 

References:  

1.Park YJ, Farooq J, Cho J, et al. Fighting the War Against COVID-19 via Cell-Based Regenerative Medicine: Lessons Learned from 1918 Spanish Flu and Other Previous Pandemics [published online ahead of print, 2020 Aug 13]. Stem Cell Rev Rep. 2020;1-24. doi:10.1007/s12015-020-10026-5 2. Cancio M, Ciccocioppo R, Rocco PRM, et al. Emerging trends in COVID-19 treatment: learning from inflammatory conditions associated with cellular therapies. Cytotherapy. 2020;22(9):474-481. doi:10.1016/j.jcyt.2020.04.100 3. Wiersinga WJ, Rhodes A, Cheng AC, Peacock SJ, Prescott HC. Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review. JAMA. Published online July 10, 2020. doi:10.1001/jama.2020.12839 4. Leng Z, Zhu R, Hou W, et al. Transplantation of ACE2– mesenchymal stem cells improves the outcomes of patients with COVID-19 pneumonia. Aging and Disease. 2020;11:216-228. 5. Liang, B., Chen, J., Li, T, et al Clinical remission of a critically ill COVID-19 patient treated by human umbilical cord mesenchymal stem cells. ChinaXiv. 2020 Advance online publication. 6. Zhang Y, Ding J, Ren S, et al. Intravenous infusion of human umbilical cord Wharton’s jelly-derived mesenchymal stem cells as a potential treatment for patients with COVID-19 pneumonia. Stem Cell Res Ther. 2020 May 27; 11(1):207. 7. Shu L, Niu C, Li R, et al. Treatment of severe COVID-19 with human umbilical cord mesenchymal stem cells. Stem Cell Res Ther. 2020;11(1):361. 

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