By Sophia Ononye-Onyia, PhD MPH MBA, Founder & CEO, The Sophia Consulting Firm
Part two of a three-part series on the future of regenerative medicine explores how 3D bioprinting will potentially save lives for millions of patients awaiting lung transplants.
Respiratory diseases are leading causes of death and disability in the world. Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide. Lung cancer is the most common cancer worldwide, accounting for almost 2 million deaths in 2018 per data from the American Lung Association. Over 10 million people develop tuberculosis (TB) and 1.4 million die from it each year, making it the most common lethal infectious disease. Most recently, COVID-19, a lung disease caused by a novel coronavirus, SARS-CoV-2, has contributed to over 850,000 deaths primarily in patients with two or more co-morbidities based on a recent report by the Centers for Disease Control and Prevention (CDC). Consequently, it comes as no surprise that requests for lung donations are in the top 5 lists worldwide. Additive manufacturing, more commonly known as 3D printing, may be the optimal solution given the prevalence of respiratory diseases.
Lung transplants are primarily restricted to Organization for Economic Cooperation and Development (OECD) countries based on high prices and availability of sophisticated medical infrastructure. Furthermore, despite high demand, only about 2,000 double lung transplants, which cost an estimated $1.2 million are expected annually here in the U.S. according to a 2020 Milliman Report. Of note, single lung transplants are significantly less common with approximately 800 procedures that cost over $900,000 per procedure. Furthermore, waiting times for lungs are about 6 months on average, which may substantially be longer or impracticable depending on a patient’s age, co-morbidities, health insurance, etc. The takeaway is that there is a distinct need for alternatives to traditional lung donations. 3D bioprinting of lungs offers hope for millions of patients in need of life-saving transplants based on speed of access, cost-effectiveness and potentially longer survival rates.
CollPlant Biotechnology is an Israeli-based regenerative and aesthetic medicine company that is using its recombinant human collagen (rhCollagen) technology platform as the source of BioInk for 3D bioprinting of organs and tissues. Through its partnership with United Therapeutics, a prominent biotechnology company headquartered in Maryland, CollPlant is working toward addressing global organ shortages through 3D bioprinting of lung scaffolds. Innately, this experience will potentially enable CollPlant to investigate 3D bioprinting of additional vital organs. In addition, 3D Systems, the leading additive manufacturing (AM) solutions company, is supporting this initiative with the development of tissue and scaffold bioprinting processes for third-party collaborators.
The vast potential and challenges for 3D bioprinting of human hearts, which are fairly similar to human lungs, were already covered in Part 1 of this “Future of Regenerative Medicine” series. Notably, the complex vasculature of the lungs as well as its independent vascular networks inclusive of the airways and blood vessels of the lung present a major roadblock for 3D bioprinting of lungs. Moreover, the timeline for clinical development and regulatory approval remains unclear with expert predictions ranging from five years to 15 years. Furthermore, there is still some uncertainty as to how regulators will classify a 3D printed organ such as a human lung. Is it an organ, a product or even a medical device? Fortunately the U.S. Food and Drug Administration (FDA) has provided some guidance on 3D-printed medical devices. However, the current guidance is not binding and does not provide details on 3D bioprinting.
In closing, COVID-19 has increased our awareness of the grave burden of respiratory diseases. 3D bioprinting of lungs holds great promise as an alternative to traditional organ transplants. Yet, there are people who question the validity of 3D bioprinting possibly because it makes them ponder on the implication that it would enable us to live eternal lives. But the beauty of scientific innovation often lies in persistence and the underlying belief that the answers will be revealed with time.
Dr. Sophia Ononye-Onyia is a Yale-trained molecular oncologist and founder and CEO of The Sophia Consulting Firm, a New York City life-sciences marketing and communications consultancy. She is also the host of her firm’s Amplifying Scientific Innovation Podcast