- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04435249
ENgineered Tissue Repair of BronchopleUral fiSTula (ENTRUST)
November 21, 2022 updated by: Videregen Limited
Phase I/II, Open Label Study to Assess the Safety and Efficacy Autologous Bone Marrow-derived Mesenchymal Stromal Cells Seeded on to Decellularised Airway Scaffold in Subjects With Clinically Significant Bronchopleural Fistula
Phase I/II Open-label Study to Assess the Safety 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.
Study Overview
Detailed Description
The proposed clinical trial is a phase I/II open-label study to assess the safety 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.
It is a phase I/II open-label study, which is an uncontrolled pilot in 5 subjects.
Study Type
Interventional
Enrollment (Anticipated)
5
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reg Affairs
- Phone Number: +44203 728 9500
- Email: regulatory@ct.catapult.org.uk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm
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.
|
Expanded somatic mesenchymal stromal cells (MSCs) seeded onto a decellularised human tracheal-scaffold
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety: Emergent or worsening Serious Adverse Events (SAEs) related to the BPF implant during the 3 months post-defect repair
Time Frame: 3 months (90 days)
|
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.
Time Frame: 3 months (90 days)
|
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 Outcome Measures
Outcome Measure |
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).
Time Frame: 36 months
|
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.
|
36 months
|
Safety and tolerability: - Adverse Events (AEs) including pre-defined postoperative AEs of special interest up to 30± 3 days post implantation- Related AEs reported after 3, 6, 9, 12, 24 and 36 months
Time Frame: 36 months
|
Adverse events related to the BPF implant procedures reported after 3, 6, 9, 12, 24 and 36 months.
|
36 months
|
Viability and the integrity of the repair area (closure) visually via bronchoscope. Integrity assessed by visual appearance of no visible leaks- Structural closure of the defect and visual health of the defect area and surrounding tissue
Time Frame: 36 months
|
viability of the repair area and integration with vascular supply at 6, 9, 12, 24 and 36 months.
|
36 months
|
Absence of other surgical interventions at 6, 9, 12, 24 and 36 months
Time Frame: 36 months
|
Interventions at the operative sites up to 6, 9, 12, 24 and 36 months
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2023
Primary Completion (Anticipated)
March 1, 2025
Study Completion (Anticipated)
November 1, 2027
Study Registration Dates
First Submitted
May 29, 2020
First Submitted That Met QC Criteria
June 16, 2020
First Posted (Actual)
June 17, 2020
Study Record Updates
Last Update Posted (Actual)
November 22, 2022
Last Update Submitted That Met QC Criteria
November 21, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UK-2019-004939-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
to follow
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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