A new clinical trial investigating the use of umbilical cord stem cells to treat chronic heart failure is currently underway.

The Phase II trial, which is the first of its kind in the U.S., is being carried out by researchers at the University of Louisville. It’s also the first time intravenous (IV) delivery will be trialled for the delivery of cell therapy for heart failure. [1]

It’s hoped that this pioneering approach could change the way that heart failure patients are treated.

What is heart failure?

Heart failure arises when the heart can’t pump blood around the body properly. This results in the body being unable to receive the oxygen it needs to function normally.

Heart failure can arise from various causes, with some of the most common being:

• Cardiomyopathy: A condition where the heart’s muscular wall thickens, making it difficult for the heart to effectively pump blood throughout the body.

• Heart Attack: A heart attack can cause lasting damage to the heart, impairing its ability to circulate blood efficiently.

• High Blood Pressure: Chronic high blood pressure puts strain on the heart, gradually reducing its pumping efficiency.

• Abnormal Heart Rhythms: An irregular, too slow, or too fast heartbeat can disrupt the heart’s normal pumping function. [2]

It’s estimated that heart failure affects more than a million people in the U.K. and at least 64 million people worldwide. [3]

Heart failure usually gets worse over time. However, while there is no cure, there are steps that can be taken to treat and manage symptoms, including surgery, having a pacemaker fitted, medication, and lifestyle changes. [4]

What is the new stem cell trial for heart disease?

The trial, which has been dubbed ‘CATO’, will enrol 60 participants across 3 locations, all of whom would have suffered from ischemic cardiomyopathy – heart failure arising from the damage caused by heart attack.

Conducted on a randomised, double blind and placebo controlled basis to ensure rigorous scientific standards, participants will be split into three groups: a control group, a single dose group and a multiple dose group.

All participants will receive four infusions delivered via IV over the course of 2 months.

The control group will receive four doses of placebo, the single dose group will receive one dose of umbilical cord-derived mesenchymal stem cells (UC-MSCs) and three doses of placebo, and the multiple dose group will receive four doses of UC-MSCs.

The first trial to test the delivery of cell therapy for heart failure in multiple doses, CATO will not only investigate the effectiveness of using UC-MSCs for treating heart failure, but also the effectiveness of their delivery in multiple infusions.

Participants will be monitored at intervals of 2 hours, 1 week, and 2 months after each infusion and then followed for 6 months after all four infusions to monitor the safety and efficacy of the therapy. [5]

Why are umbilical cord stem cells being used in the heart failure trial?

Previous studies have shown that mesenchymal stem cells derived from the umbilical cord have abilities that make them ideal in the treatment of cardiovascular diseases.

These include the ability to differentiate into cardiovascular progenitor cells, to modulate immune responses, and promote growth factors. [6] [7]

These cells, harvested from donated umbilical cords, have shown promise in treating a range of conditions, including ulcerative colitis, Crohn’s disease, and even COVID-19. [8] [9] [10]

Now, for the first time in the United States, they are being tested in heart failure patients.

UC-MSCs offer several advantages in this area over other types of stem cells.

Most notably, UC-MSCs can be isolated, stored frozen and then expanded into large quantities, making them readily available “off the shelf” when needed.

This reduces both the cost and the time required to initiate treatment, making it more accessible to a broader range of patients. [11]

Researchers leading the trial hope that umbilical cord-derived mesenchymal stem cells will provide a new and much needed therapeutic alternative in the treatment of heart failure.

Should I save my baby’s umbilical cord stem cells?

This trial demonstrates the growing interest and potential of umbilical cord stem cells to combat conditions, like heart failure, that are currently incurable.

If you have a history of heart disease in your family, it’s probably worth saving the stem cells from your baby’s umbilical cord.

While the stem cells used in this trial will be sourced from donated umbilical cords, privately storing the stem cells from your baby’s umbilical cord rules out the risk of rejection by ensuring that they always have access to stem cells from their own perfect match: themselves.

It also gives them the best chance of accessing future stem cell therapies currently being developed in clinical trials not just for heart failure but also for diseases and conditions like cancer, stroke, and Parkinson’s disease.

If you or a family member are expecting and want to know more about private stem cell storage, fill out the form below to receive your free Welcome Pack.

References

[1] UofL News (2024, August 6). UofL cardiologist leading clinical trial for high potential new therapy for heart failure. University of Louisville School of Medicine. https://louisville.edu/medicine/news/uofl-cardiologist-leading-clinical-trial-for-high-potential-new-therapy-for-heart-failure

[2] Heart failure. British Heart Foundation. https://www.bhf.org.uk/informationsupport/conditions/heart-failure?gad_source=1&gclid=Cj0KCQjww5u2BhDeARIsALBuLnP2GAM0j5TBp0pX-OL9l3Vgzt8yZWBcKKk8j5T0m_JI8pHKPqZKiY8aAi02EALw_wcB&gclsrc=aw.ds

[3] Nicola Luigi Bragazzi, Wen Zhong, Jingxian Shu, Arsalan Abu Much, Dor Lotan, Avishay Grupper, Arwa Younis, Haijiang Dai, (2021) Burden of heart failure and underlying causes in 195 countries and territories from 1990 to 2017, European Journal of Preventive Cardiology, Volume 28, Issue 15, December 2021, Pages 1682–1690, https://doi.org/10.1093/eurjpc/zwaa147

[4] (2022, May 19). Overview: Heart failure. NHS. https://www.nhs.uk/conditions/heart-failure/

[5] (2024, June 13). Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy (CATO). ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT06145035

[6] Abouzid, M. R., Ali, K., Kamel, I., Esteghamati, S., Saleh, A., & Ghanim, M. (2023). The Safety and Efficacy of Human Umbilical Cord-Derived Mesenchymal Stem Cells in Patients With Heart Failure and Myocardial Infarction: A Meta-Analysis of Clinical Trials. Cureus, 15(11), e49645. https://doi.org/10.7759/cureus.49645

[7] Bartolucci, J., Verdugo, F. J., González, P. L., Larrea, R. E., Abarzua, E., Goset, C., Rojo, P., Palma, I., Lamich, R., Pedreros, P. A., Valdivia, G., Lopez, V. M., Nazzal, C., Alcayaga-Miranda, F., Cuenca, J., Brobeck, M. J., Patel, A. N., Figueroa, F. E., & Khoury, M. (2017). Safety and Efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients With Heart Failure: A Phase 1/2 Randomized Controlled Trial (RIMECARD Trial [Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy]). Circulation research, 121(10), 1192–1204. https://doi.org/10.1161/CIRCRESAHA.117.310712

[8] Lin, Y., Lin, L., Wang, Q., Jin, Y., Zhang, Y., Cao, Y. and Zheng, C. (2015), Transplantation of human umbilical mesenchymal stem cells attenuates dextran sulfate sodium-induced colitis in mice. Clin Exp Pharmacol Physiol, 42: 76-86. https://doi.org/10.1111/1440-1681.12321

[9] Zhang, J., Lv, S., Liu, X., Song, B., & Shi, L. (2018). Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn’s Disease: A Randomized Controlled Clinical Trial. Gut and liver, 12(1), 73–78. https://doi.org/10.5009/gnl17035

[10] Guo, B. C., Wu, K. H., Chen, C. Y., Lin, W. Y., Chang, Y. J., Lee, T. A., Lin, M. J., & Wu, H. P. (2023). Mesenchymal Stem Cells in the Treatment of COVID-19. International journal of molecular sciences, 24(19), 14800. https://doi.org/10.3390/ijms241914800

[11] UofL News (2024, August 6). UofL cardiologist leading clinical trial for high potential new therapy for heart failure. University of Louisville School of Medicine. https://louisville.edu/medicine/news/uofl-cardiologist-leading-clinical-trial-for-high-potential-new-therapy-for-heart-failure

In a study first published in April’s edition of Advanced Functional Materials, researchers found that stem cells boost natural repair following cardiac arrest.

The most common consequence of cardiac arrest is brain injury. Decreased blood flow and oxygen to the brain can result in damage to specific areas such as the temporal lobe, which is responsible for memories. [1]

According to the British Heart Foundation, there are around 30,000 out of hospital cardiac arrests in the UK per year, with survival rates of only 1 in 10.

While there are currently steps towards improving these survival rates – mainly public awareness and educational campaigns focused on immediate response [2] – better survival rates potentially means more patients suffering from brain injury, which can range in severity.

What researchers at the University of Maryland School of Medicine in the U.S. have found is that neural stem cells can help with repairing post-cardiac arrest brain damage when their carbohydrate structure is manipulated. [3]

In an animal study using rats, scientists applied sugar molecules to the neural stem cells in a process called glycoengineering.

It’s thought that the application of these sugar molecules provide the neural stem cells with a better chance of retention and integration within the harsh microenvironment of the brain.

Researchers examined the efficacy of the ‘sugar-coated’ neural stem cells that had been pretreated with TProp (the name of the modified sugar molecule applied) with naive human neural stem cells.

They found through subsequent testing that the stem cells that had been pretreated with TProp improved brain function substantially, along with reducing anxiety and depression-related behaviours.

The ability for synapses to modify the strength of their connections (otherwise known as synapse plasticity) also improved, with the TProp group also demonstrating a reduction in neuroinflammation in the central nervous system.

Overall, the findings from the University of Maryland are promising as they indicate that these glycoengineered stem cells could help regenerate connections between synapses in the brain that have been affected by cardiac arrest related injury in humans.

The next steps will involve tests on larger animals before hopefully moving to a clinical study.

If you want to know more about how you can save your baby’s powerful stem cells, fill out the form below for your free welcome pack.

References

[1] (2023, July 7). Can a heart attack cause brain damage? Medical News Today. https://www.medicalnewstoday.com/articles/heart-attack-brain-damage#effects

[2] Horriar, Lina et al. “Improving survival after cardiac arrest in Europe: The synergetic effect of rescue chain strategies.” Resuscitation plus vol. 17 100533. 21 Dec. 2023, doi:10.1016/j.resplu.2023.100533

[3] (2024, May 9). Stem Cell Therapy Boosts Natural Repair After Cardiac Arrest. University of Maryland Baltimore. https://www.umaryland.edu/news/archived-news/may-2024/stem-cell-therapy-boosts-natural-repair-after-cardiac-arrest.php