For the attention of laryngologists: call for recruits to a clinical trial
RegenVOX Trial: A stage 2a clinical trial of stem cell based tissue engineered partial laryngeal
replacement grafts
Chief Investigator: Professor Martin Birchall, UCL Ear Institute
We are now recruiting to the RegenVOX trial.
This is a groundbreaking MRC funded clinical trial sponsored by University College London. We will
use autologous stem cell based, tissue engineered partial (non-moving, but anatomically matched)
laryngeal replacement grafts in 10 adult patients with advanced laryngeal and upper tracheal
disorders.
Following successful trialling in pigs, we have refined technology to produce and implant a partial
laryngeal or upper tracheal replacement. This is composed of a human donor decellularised scaffold
(obtained through UK Blood and Transplant) re-seeded with autologous (patient’s own) stem cells.
We have previously achieved proof-of-principle through compassionate use tracheal implants in three
patients using similar technology.
The intention is to allow these rare but functionally disabled patients to lead lives with a prosthesisand tracheostomy-free airway, improve voice and swallowing function and reduce the need for repeat
admissions and operations. This would benefit patients and those who care for them and reduce
patient, society and healthcare costs. If successful in these patients with benign pathology, this
technology could significantly extend therapeutic options for head and neck cancer patients as well,
reduce rates of laryngectomies and the threshold for selecting surgery over chemoradiotherapy,
thereby reducing morbidity.
Inclusion criteria:
 Patients aged 18-70 years with Myer-Cotton Grade 3 or 4 laryngotracheal stenosis due to
traumatic, iatrogenic, inflammatory or idiopathic causes who have exhausted conventional
therapies. We include those with low grade malignant or benign tumours of the larynx who
might be heading for laryngectomy in time, and those who have had partial laryngeal
resections for laryngeal cancer and are recurrence free at a minimum of 2 years.
Exclusion criteria:
 Pregnancy

Those unable to provide informed consent

Co-morbid moderate or severe chronic obstructive pulmonary disease (according to NICE
criteria in CG101)

Patients with active / uncontrolled chronic inflammatory conditions such as granulomatosis
with polyangitis (Wegener’s) and sarcoidosis

Any current or previous cancer within 5 years (except non-melanoma skin cancer, adequately
treated carcinoma in situ of the uterine cervix and laryngeal malignancy treated locally without
distant metastases)

Life expectancy less than 5 years
If you have patients who fulfil these criteria and may be interested in participating in our trial, or if you
require further information about the trial then please contact the trial team via:
Sophie Wilson
RegenVOX Clinical Research Nurse
University College London
Email: sophie.wilson@ucl.ac.uk
Martin Birchall
Professor of Laryngology
Royal National Throat Nose & Ear Hospital
m.birchall@ucl.ac.uk