Clinical Trial of Stem Cell Based Tissue Engineered Laryngeal Implants (RegenVOX)
Disorder of Upper Respiratory System, Laryngostenosis, Tracheal Stenosis
About this trial
This is an interventional treatment trial for Disorder of Upper Respiratory System focused on measuring Airway reconstruction, Regenerative medicine
Eligibility Criteria
Inclusion Criteria:
Patients aged >=18 years with sufficient numbers of Mesenchymal Stromal Cells (MSCs) in their 8-10ml human Bone Marrow (hBM) aspirate.
Patients with Myer-Cotton Grade 3 or 4* laryngotracheal stenosis or equivalent due to traumatic, inflammatory, iatrogenic, or idiopathic causes who have exhausted conventional therapies.
*The Myer-Cotton grading system for mature, firm, circumferential stenosis, confined to the subglottis describes the stenosis based on the per cent relative reduction in cross-sectional area of the subglottis. Four grades of stenosis:
- grade 1 lesions have less than 50% obstruction
- grade 2 lesions have 51% to 70% obstruction
- grade 3 lesions have 71% to 99% obstruction
- grade 4 lesions have no detectable lumen or complete stenosis
Exclusion Criteria:
- Pregnancy
- Patients positive for HIV 1, HIV 2, HCV, HBV, syphilis or HTLV
- Those unable to provide informed consent
- Co-morbid severe chronic obstructive pulmonary disease (according to NICE criteria)
- Patients with active / uncontrolled chronic inflammatory conditions such as granulomatosis with polyangitis (formerly Wegener's granulomatosis) and sarcoidosis
- Any current or previous cancer within 5 years (except non-melanoma skin cancer, adequately treated carcinoma in situ of the uterine cervix, laryngeal malignancy treated locally with no local recurrence and no metastases, or low grade airway malignancy such as chondrosarcoma which may be causing airway obstruction)
- Life expectancy less than 5 years unless this limitation is principally due to the airway obstruction to be treated
- Concurrent enrollment in any other Clinical Trial of Investigational Medicinal Product (CTIMP).
Sites / Locations
- University College London NHS Foundation Trust (UCLH)
Arms of the Study
Arm 1
Experimental
Tissue engineered airway construct
Stem cell based tissue engineered partial laryngeal implants: The final experimental product is a highly tested, recellularised, stem cells based tissue engineered product (airway construct) for operative partial laryngeal implantation into patients with severe laryngotracheal stenosis