ENgineered Tissue Repair of BronchopleUral FiSTula | NCT04435249

NCT04435249

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Cell Therapy Catapult	OTHER
Papworth Hospital NHS Foundation Trust	OTHER_GOV
Royal Free Hospital NHS Foundation Trust	OTHER

Description Module

Label	Type	Description	Intervention Names
Treatment Arm	Experimental	Patients will have a patch of expanded somatic mesenchymal stromal cells (MSCs) seeded onto a decellularised human tracheal-scaffold surgically implanted to repair bronchial fistula.	Other: BPF-001

Name	Type	Description	Arm Group Labels	Other Names
BPF-001	Other	Expanded somatic mesenchymal stromal cells (MSCs) seeded onto a decellularised human tracheal-scaffold	Treatment Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety: Emergent or worsening Serious Adverse Events (SAEs) related to the BPF implant during the 3 months post-defect repair	Safety: Emergent or worsening Serious Adverse Events (SAEs) related to the BPF implant during the 3 months post-defect repair.	3 months (90 days)
Efficacy: Bronchopleural Fistula (BPF) closure at 3 months assessed by visual appearance and no clinical signs of leaks.	Closure of BPF with no need for further surgical closure. Efficacy will be deemed demonstrated if 2 or more subjects meet the primary endpoint.	3 months (90 days)

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in Physiological and Quality of Life scores at 3, 6, 9, 12 months, Evaluation Questionnaire 5D (EQ-5D), 6-minute walking test (6MWT), ambulatory oxygen (O2).	Impact as assessed in change from Baseline in Physiological and Quality of Life scores for each subject at 3, 6, 9, 12, 24 and up to 36 months post defect repair: QoL EQ-5D, 6-minute walking test, ambulatory O2 measurements.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Bone Marrow Aspirate.

Exclusion Criteria:

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.
Subjects with clinically relevant or recent (within 2 years) history of substance abuse, including alcohol.
Subject who has participated in any other interventional clinical trial within previous 30 days of the start of this study.
Subjects with known presence of Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody.
Subject who, in the investigator's judgement, is unlikely to complete all protocol required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
Subjects with any medical condition, that in the investigator's judgement, is likely to interfere with assessment of safety or efficacy of study treatment.
Subject who is pregnant.
Subjects with cancer (except for controlled or controllable basal cell carcinoma).