Five-Year Consortium Plans Bioengineered Hearts for Children

Boston Children’s Hospital, Harvard’s John A. Paulson School of Engineering and Applied Sciences, Brigham and Women’s Hospital, and NTT Research have launched THUMPIN’, a research consortium intended to develop living cardiac tissues and, ultimately, a complete functioning heart for infants and young children with congenital heart disease. The Boston Children’s-led initiative is supported by an Advanced Research Projects Agency for Health contract worth up to $29.6 million over as many as five years, along with other funders. Its stated long-term goal is to engineer heart components that can be assembled into a whole heart and could grow and adapt as children develop. The announcement describes a research and development program, not an available treatment, and reports no human efficacy results.

THUMPIN’ stands for Tissue-engineered Hearts Using Multimodal Printing in Newborns. The consortium is intended to address the clinical burden of complex congenital heart defects, including situations in which infants and young children undergo surgery after surgery as they grow and some eventually exhaust available options. Kit Parker, the consortium’s principal investigator, said the program brings clinicians and researchers together to rethink pediatric heart care through living hearts and heart parts that “grow, function, and adapt throughout childhood.” The target population is infants and young children with congenital heart disease, but the announcement does not identify a specific defect, number of participants, or eligibility criteria for future testing.

Parker is a senior scientist at Boston Children’s Hospital, the Tarr Family Professor of Bioengineering and Applied Physics at SEAS, and director of the DesignBio Group at SEAS. The team draws on expertise in pediatric cardiac surgery, tissue engineering, stem cell biology, additive manufacturing, and computational modeling. Pedro del Nido, chair of Boston Children’s Department of Cardiac Surgery and a THUMPIN’ investigator, will lead the program’s implantation studies. The announcement also names William Pu, Juan Melero-Martin, Vassilios J. Bezzerides, Elena Aikawa, and Joe Alexander as investigators. Aikawa is affiliated with Brigham and Women’s Hospital and the Mass General Brigham Heart and Vascular Institute, while Alexander represents NTT Research.

During the five-year project, researchers plan to develop and test cells, tissues, manufacturing methods, and computational tools for engineering living cardiac structures. Listed targets include heart valves, vascular grafts, myocardial patches, components of the conduction system, and single ventricles. The team also intends to work toward a whole heart. Alongside its biological work, THUMPIN’ will establish the manufacturing, safety, and regulatory foundation needed to move the technology toward possible future human studies. These are planned activities and development goals; the announcement does not report that the consortium has completed a functional bioengineered heart or demonstrated clinical benefit in children.

The technical program is expected to advance from laboratory testing to studies of bioengineered heart tissues in large-animal models. That sequence would allow investigators to examine the tissues in a living system before any possible clinical evaluation while also working toward the manufacturing and regulatory preparation required for translation. Del Nido said the central task is to determine whether living heart tissue can be made safe, functional, and ultimately translatable to patients. The statement sets out a research question rather than an established outcome: THUMPIN’ has not yet shown that a complete bioengineered heart can grow or function in children, nor has it demonstrated effects on survival or other clinical outcomes.

A central feature of the consortium’s approach is the combination of biofabrication, regenerative medicine, and computational methods. Additive manufacturing is represented by the team’s expertise, the use of cells and tissues reflects regenerative medicine, and computational modeling will support design and testing work. Alexander said the computational models are intended to help physicians better understand and treat cardiovascular disease. Aikawa described the convergence of biofabrication, regenerative medicine, and computational approaches as an opportunity to develop solutions long considered out of reach. The announcement does not specify the cell sources, fabrication protocols, computational techniques, animal species, test endpoints, or manufacturing quality measures, leaving those details to be developed during the project.

Manufacturing work will be led in partnership with Landmark Bio, a public-private company co-founded by Harvard University, MIT, and industry partners, with Boston Children’s Hospital and Brigham and Women’s Hospital serving as collaborating institutions. Parker said the project must build not only a heart but also the clinical and industrial capacity required to support its deliverables as therapeutic options. The program will therefore connect the biological research with work on manufacturing, safety, and regulatory requirements. The consortium aims to create the foundation for an eventual U.S. Food and Drug Administration Investigational Device Exemption and bring first-in-human clinical studies closer, but the announcement does not say that such an exemption has been sought or granted.

THUMPIN’ is part of the ARPA-H Personalized Regenerative Immunocompetent Nanotechnology Tissue program, known as PRINT, which is led by program manager Ryan Spitler. The initiative brings together researchers working across tissue engineering, pediatric surgery, computation, manufacturing, safety, and regulatory preparation. Its collaborators include academic hospitals, a Harvard engineering school, an industrial research organization, and a manufacturing company. The release also describes Boston Children’s Hospital as a comprehensive center for pediatric and adolescent health care and Harvard Medical School teaching affiliate, while Mass General Brigham is identified as an integrated academic health-care system. The announcement presents these affiliations as the foundation for combining clinical and technical expertise, not as evidence that the proposed therapy is ready for patients.

The program’s central distinction is its explicit aim to create living replacement tissues rather than only repair damaged cardiac structures. Living tissue could, in principle, accommodate growth as a child develops, and THUMPIN’ investigators have framed that possibility as the motivation for developing heart parts that can grow, function, and adapt throughout childhood. That remains a goal rather than a demonstrated property of the planned products. The announced research path includes cell and tissue development, laboratory testing, large-animal implantation studies, manufacturing development, safety work, and regulatory preparation. No results from those stages, including any pediatric clinical outcome, are reported in the announcement, and the consortium has not reached human testing. Its stated destination is a set of living cardiac components and, ultimately, a complete heart for children with congenital heart disease, with translation to first-in-human studies still dependent on successful development and regulatory steps.

Subject of Research: Research and development of living bioengineered cardiac tissues for children with congenital heart disease

Article Title: Boston Children’s Hospital, Harvard School of Engineering and Applied Sciences, Brigham and Women’s Hospital, and NTT Research announce THUMPIN’ initiative to develop living, bioengineered heart tissues for children

Article References: Boston Children’s Hospital, Harvard School of Engineering and Applied Sciences, Brigham and Women’s Hospital, and NTT Research announce THUMPIN’ initiative to develop living, bioengineered heart tissues for children. Original publication (Bibliographic details unavailable.)

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Keywords: THUMPIN’ consortium, bioengineered hearts, pediatric congenital heart disease, cardiac tissue engineering, stem cell biology, additive manufacturing, computational modeling, large-animal models, regulatory preparation, ARPA-H, Boston, Children