Clinical trial of a voicebox implant using tissue engineering

Phase 1

• Conditions: Disorder of Upper Respiratory SystemLaryngostenosisTracheal Stenosis; MedDRA version: 18.0Level: PTClassification code 10062034Term: Laryngeal operationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0Level: PTClassification code 10023862Term: Laryngeal stenosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 18.0Level: PTClassification code 10050816Term: Tracheal stenosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2013-004359-18-GB
• Lead Sponsor: niversity College London (UCL) hereby represented by UCL Comprehensive Clinical Trials Unit(CCTU)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-23
• Last Update Posted: 6 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients aged >=18 years with sufficient numbers of Mesenchymal Stromal Cells (MSCs) in their 8-10ml human Bone Marrow (hBM) aspirate procured at screening for the production of adequate cell numbers for TEP-PaL.
Patients with Myer-Cotton Grade 3 or 4* laryngotracheal stenosis or equivalent morbidity due to traumatic, inflammatory, iatrogenic, neoplastic (benign or low grade malignant) or idiopathic causes who have exhausted conventional therapies.
(This will be determined by a fully constituted complex airway multidisciplinary team).

*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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Pregnancy.
Those unable to provide informed consent.
Co-morbid severe chronic obstructive pulmonary disease (COPD) (according to NICE clinical guideline CG101.
Patients with active / uncontrolled chronic inflammatory conditions such as granulomatosis with polyangitis (formerly known as 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 without local recurrence or metastases or low grade airway tumours such as chondrosarcoma which may be causing airway obstruction.
Life expectancy less than 5 years unless such limitation is largely due to the airway stenosis to be treated herein (as assessed by consultant trial clinician or referring clinician).
Concurrent enrolment in any other CTIMP.
Patients positive for HIV 1, HIV 2, HCV, HBV, syphilis or HTLV.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We aim to assess the safety of stem cell based tissue engineered partial voice box replacement implants for the treatment of severe narrowing of the voice box and/or upper windpipe in adults. ;Secondary Objective: We also aim to assess the potential efficacy of stem cell based tissue engineered partial voice box replacement implants for the treatment of severe narrowing of the voice box and/or upper trachea. <br><br>Our objectives are to assess whether this treatment is effective in terms of significantly improving functions of breathing, speaking and swallowing, improving quality of life for patients and reducing the burden on healthcare systems. ;Primary end point(s): Safety as defined by mortality and morbidity as measured by occurrence of adverse events / reactions;Timepoint(s) of evaluation of this end point: Throughout the whole study lifetime at each study visit up to 24 months post stage 2 implantation procedure.