Phase I/II open-label study to assess the safety, tolerability and efficacy of a novel tissue engineered airway product, consisting of expanded autologous bone marrow (BM) derived Mesenchymal Stromal Cells (MSC) seeded on to a decellularised allogeneic patch of an airway scaffold in subjects with clinically significant bronchopleural fistula.

Cell and Gene Therapy Catapult0 sites5 target enrollmentFebruary 4, 2020

Overview

No summary available.

Registry

who.int

Start Date

February 4, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Male or female subjects 18 years or older.
•Documented diagnoses of BPF through imaging and bronchoscopic examination.
•BPF which involves the tracheobronchial junction or proximal bronchus.
•Subjects who have failed primary repair.
•Subjects who have no evidence of any primary or recurrent cancer (not limited to the surgical site) at the time of pre\-operative screening as evidenced by CT and/or targeted biopsy (except for controlled or controllable basal cell carcinoma.
•Subjects who have signed and dated written informed consent to participate in the study.
•Females of childbearing potential (i.e. not surgically sterilised or post\-menopausal for at least 2 years) must have a negative serum or urine pregnancy test.
•Male and female subjects of childbearing potential (i.e. not surgically sterilised or post\-menopausal for at least 2 years) must use forms of highly effective methods of contraception, which are defined as hormonal methods of contraception (oral, injection or implant), barrier methods (condom or occlusive cap (diaphragm or cervical/vault caps)) with spermicidal foam/gel/cream/film/suppository, or true abstinence for 1 month following surgery.
•Subjects who have produced viable cells from BMA.
•Are the trial subjects under 18? no

•Subjects who have received previous treatment with another Advanced Technology Medicinal Product (ATMP).
•Subjects with ECOG performance status of 3 or 4\.
•Subjects deemed not suitable for surgery by the MDT.
•Uncontrolled diabetes, defined as HbA1c levels above 7\.0 %.
•Any medical condition contraindicating the ability to tolerate general anaesthetic in the judgement of a consultant anaesthetist.
•Subjects who have a severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
•Subjects with clinically significant renal and liver impairment.
•Subjects undergoing an immunosuppression regimen or suffering from a primary immunodeficiency syndrome.
•Subjects with any known hypersensitivity to the culture and transport media compounds.
•Subjects with current or recurrent disease that could affect the administration, the action or disposition of the investigational product, or clinical or laboratory assessments.