The study's primary objectives are to assess the effects of nitric oxide in perfused ex-vivo lungs using a proprietary grading system and to evaluate the total ex-vivo perfusion time of the lungs through periodic assessments during Ex-Vivo Lung Perfusion (EVLP).
EVLP describes a process of evaluating and preparing donor lungs outside the body; nutrients are perfused, or circulated, through the organ, and the organ is ventilated to mimic physiologic function prior to transplant surgery. EVLP has the potential to increase the available donor pool through restoring and repairing donor lungs.1
About the Study
This proof-of-concept randomized, multicenter, blinded study will assess the effects of nitric oxide in modified criteria human lung transplants via EVLP. It is planned to be conducted at four major U.S. lung transplant centers through the fourth quarter of 2018. The study will evaluate extended criteria bilateral donor lungs, not suitable for lung transplantation. Upon a successful proof-of-concept study, the company expects to initiate a safety study to assess use of nitric oxide in human lung transplantation in 2019.
About Lung Transplantation in Humans
In the U.S. each year, about 2,000 people receive a lung transplant2 – the surgical replacement of either a single or two (double) badly diseased lungs with healthy lungs from a human organ donor. A variety of diseases and conditions can damage a person's lungs and hinder their ability to function effectively, such as chronic obstructive pulmonary disease (COPD) including emphysema; scarring of the lungs; pulmonary fibrosis; cystic fibrosis; sarcoidosis; and pulmonary hypertension.3 A major limiting factor to the number of transplants performed is donor lung shortage.4 According to Organ Procurement Transplant Network data, approximately 1,400 patients with severe lung disease are on the waiting list for a transplant.5
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning
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1 Columbia University Department of Surgery Center for Advanced Lung Disease and Transplantation.
2 Valapour M, Skeans MA, Smith JM, et al. OPTN/SRTR 2015 Annual Data Report: Lung. American Journal of Transplantation. 2017;17:357-424. doi:10.1111/ajt.14129.
3 Mayo Clinic Patient Care and Health Information, Lung Transplant. https://www.mayoclinic.org/tests-procedures/lung-transplant/about/pac-20384754 Accessed April 9, 2018.
4 Van Raemdonck D; Neyrinck A; Verleden GM, et al. Lung Donor Selection and Management. Annals of the American Thoracic Society. 2009; 6:28-38.
5 Organ Procurement and Transplant Network Data. https://optn.transplant.hrsa.gov/data/ Accessed April 26, 2018.
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