CSA Medical Inc has initiated treatments in a clinical study to evaluate the safety and feasibility of treating chronic bronchitis patients with the RejuvenAir System, a “cryotherapy” spray that freezes and ablates unwanted tissue inside the lungs.
The first treatment was successfully performed at the University Medical Center Groningen in Groningen, The Netherlands on March 22, according to a company press release.
The treatment “functioned as anticipated with smooth delivery of the liquid nitrogen Metered Cryospray allowing us to safely complete the anticipated treatments in the right lower lobe. The team looks forward to continued enrollment for this initial safety and feasibility trial for our highly symptomatic chronic bronchitis patients,” said Dr Slebos.
The second treatment was successfully performed in London, England on March 23. The research team led by Dr Pallav Shah MD, MBBS, FRCP, Consultant Physician at Royal Brompton Hospital and Chelsea and Westminster Hospital, treated the first UK patient with revolutionary new cryospray system for patients with chronic cough and sputum production.
“The RejuvenAir System cryospray treatment is an exciting new therapy for the challenging symptoms in patients with chronic bronchitis where currently the only option is to reduce the thickness of the mucus with medication,” said Dr Shah.
The RejuvenAir System is designed to spray liquid nitrogen at -196oC in a circumferential pattern within the airway. It is anticipated that the rapid freezing of the epithelial layer of the airway walls will destroy the mucus-producing goblet cells while preserving the extracellular matrix, thereby enabling the regrowth of healthy cells.
The Safety and Feasibility Study of RejuvenAir for Treating Chronic Bronchitis Patients (NCT02483637) is a prospective, open label, single arm, two phase study with sequential accrual of patients with known chronic bronchitis. Phase A will enroll up to 12 patients and will treat a single lobe to assess safety, feasibility and histologic/immunologic response.
After review and approval of the Phase A data by the Data Safety Monitoring Board, Phase B of the study will begin. In Phase B of the study, Phase A patients will have their remaining lobes treated. In Phase B, up to 24 additional patients will be enrolled. Once all patients have received complete treatment of both lungs they will be periodically followed for safety and physiologic response of their underlying chronic bronchitis to this novel treatment.