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Over the past several decades, significant medical advancements have extended the lifespan and improved the quality of life for children with complex congenital heart defects (CHDs).1 Despite this progress, many cardiac patients who receive prosthetic devices such as valves or patches may require lifelong therapy to prevent rejection and clotting.2,3 Additionally, stability of these patients may be threatened by the inability of cardiac devices to grow with the patient over time, requiring subsequent open-heart surgeries as patients outgrow their devices.4 Future research for patients with CHDs will explore the potential to overcome these limitations by using a patient’s own newborn stem cells for more precise and personalized treatments.
Available to qualifying families in Canada and in the United States, the Newborn Possibilities Program provides no-cost access to newborn stem cells for families with qualifying medical needs for which these cells may be used in an approved treatment or for an investigational therapy in a clinical trial. Through this collaborative expansion of the program, families of children with prenatally diagnosed complex CHDs can receive no-cost stem cell processing and 18 years of storage. Once the research repository has been established, Children’s Wisconsin’s HHI will use a patient’s own newborn stem cells to potentially develop individualized therapies for CHDs. Participating families who are later candidates for surgery at HHI will be required to travel to Children’s Wisconsin in Milwaukee. However, families of children with complex CHDs in other geographic areas, who opt not to travel to Milwaukee, can still participate in the Newborn Possibilities Program and are eligible for the standard 5 years of no-cost enrollment and storage of their newborn stem cells.
Investigating a role doe newborn stem cells in cardiac repair
CHDs are among the most common birth defects, affecting an estimated 40,000 births annually in the United States.5 While some cardiac conditions resolve after birth without surgery, many complex congenital heart defects require surgical repair and insertion of devices or other implants. By using patients’ own stem cells, researchers hope to investigate the potential to develop cardiac implants that can grow with the patient into adulthood. Cooper Surgical’s collaboration with HHI hopes to improve long-term outcomes of cardiac patients through personalized “precision medicine” that could be tailor-made for patients’ specific circumstances.
The notion of using cell-based therapies to treat patients with CHDs and other cardiovascular disease has led to the development of multiple clinical trials, including several studies that have investigated the potential for stem cells, including mesenchymal stem cells from umbilical cord tissue, to help adults with advanced cardiovascular disease. 6,7,8 Recent trials have also investigated the use of cell-based therapies for children with cardiac defects,9 including an ongoing trial for children with single ventricle defects.10 In this study, the Mayo Clinic’s Dr. Timothy Nelson and his team are conducting innovative research using autologous stem cells from umbilical cord blood from babies diagnosed with hypoplastic left heart syndrome, a severe single-ventricle defect that requires a series of three surgeries in the first few years of life. Participants in this clinical trial receive an intracardiac injection of their own concentrated cord blood stem cells during the second of these open-heart surgeries in hopes of strengthening the right side of the heart, which bears the physical burden in these patients. The focus of this research is to use cord blood stem cells to strengthen the right heart, thereby hoping to prevent long-term heart failure and the need for a heart transplant later in life.11
Cooper Surgical’s role in potentially improving the lives of cardiac
For more than a decade, families of babies who are prenatally diagnosed with complex CHDs have been eligible for no-cost enrollment and 5 years of storage through the Newborn Possibilities Program. This novel collaboration with Children’s Wisconsin’s HHI is one way Cooper Surgical is working to make these potential therapeutic options even more accessible to those families who stand to benefit most from advances in cell-based therapy.
Delivery of stem cells to the diseased or damaged heart may prove to be beneficial relative to surgery alone, particularly in terms of long-term stability and quality of life. While more research is needed to determine the potential role of newborn stem cells for cardiac repair and regeneration, Cooper Surgical is proud to play a role in this potentially groundbreaking therapeutic approach for congenital heart defects. Our hope is that this research will not only benefit families of children with complex CHDs, but that it will lay the groundwork for future cell-based therapies for other conditions for which no current cure is available. By taking advantage of the one-time opportunity to preserve newborn stem cells, we hope that increasingly more families, particularly those affected by chronic disease, will have access to this potentially invaluable resource for future therapeutic advancements.
- Guseh S and Tworetzky W (2024). Transforming congenital heart disease management: Advances in fetal cardiac interventions. Prenat Diagn. Jun;44(6-7):733-738. 2. Harris ag, Iacobazzi D, Caputo M, et al. (2023). Graft rejection in paediatric congenital heart disease. Transl Pediatr. Aug 31;12(8):1572-1591. 3. Webber, SA. (2003). The current state of, and future prospects for, cardiac transplantation in children. Cardiol Young. Feb:13(1):64-83. 4. Zhu MZL, Burrato E, Wu DM, et al. (2024). Long-Term outcomes of Mechanical Aortic Valve Replacement in Children. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 27:52-60. 5. Brown MA, Rajamarthandan S, Francis B, et al. (2020). Update on stem cell technologies in congenital heart disease. J Card Surg. Jan;35(1):174-179. 6. Ulus AT, Mungan C, Kurtoglu M, et al. (2020). Intramyocardial transplantation of umbilical cord mesenchymal stromal cells in chronic ischemic cardiomyopathy: a controlled, randomized clinical trial. Int J Stem Cells.13:364–376. 7. Kasai-Brunswick TH, Carvalho AB, Campos de Carvalho AC (2021). Stem cell therapies in cardiac diseases: Current status and future possibilities. World J Stem Cells. Sep 26; 13(9): 1231–1247. 8. Abouzid MR, Umer AM, Jha SK, et al. (2024). Stem Cell Therapy for Myocardial Infarction and Heart Failure: A Comprehensive Systematic Review and Critical Analysis. Cureus. May;16(5). 9. Tsilimigras DI, Oikonomou EK, Moris D, et al. (2017). Stem Cell Therapy for Congenital Heart Disease: A Systematic Review. Circulation. Dec 12;136(24):2373-2385. 10. Burkhart HM, Qureshi MY, Rossano JW, et al. (2019). Autologous stem cell therapy for hypoplastic left heart syndrome: Safety and feasibility of intraoperative intramyocardial injections. J Thorac Cardiovasc Surg. Dec;158(6). 11. The CHILD Trial: Hypoplastic Left Heart Syndrome Study. (CHILD). ClinicalTrials.gov identifier: NCT03406884. Updated July 11, 2024. Accessed August 23, 2024. https://clinicaltrials.gov/study/NCT03406884.