Bronchopleural FistulaPhase 1/2ENTRUSTNCT04435249
ENgineered Tissue Repair of BronchopleUral FiSTula
A Phase 1/2 study testing BPF-001 in people with Bronchopleural Fistula, run by Videregen Limited.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Bronchopleural Fistula
- What is being tested?
- BPF-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Nov 2028
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchopleural Fistula
- Being tested
- BPF-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPF-001Other
Expanded somatic mesenchymal stromal cells (MSCs) seeded onto a decellularised human tracheal-scaffold
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: BPF-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months (90 days)
Secondary outcomes (4)
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.
Measured: 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
Adverse events related to the BPF implant procedures reported after 3, 6, 9, 12, 24 and 36 months.
Measured: 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
viability of the repair area and integration with vascular supply at 6, 9, 12, 24 and 36 months.
Measured: 36 months
Absence of other surgical interventions at 6, 9, 12, 24 and 36 months
Interventions at the operative sites up to 6, 9, 12, 24 and 36 months
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study startOct 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionNov 2028 (estimated)
Why it stopped: Funding constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopleural FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Videregen Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cell Therapy Catapult, Papworth Hospital NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435249
- Sponsor's protocol ID
- UK-2019-004939-24
- Acronym
- ENTRUST
- Status last verified
- Mar 2025
- First submitted
- 29 May 2020
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to follow
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04435249
- Acronym / sponsor ID
- ENTRUST / UK-2019-004939-24
- Conditions
- Bronchopleural Fistula
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding constraints
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Videregen LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Cell Therapy Catapult, Papworth Hospital NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust
- Study start
- Oct 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Other: BPF-001Patients will have a patch of expanded somatic mesenchymal stromal cells (MSCs) seeded onto a decellularised human tracheal-scaffold surgically implanted to repair bronchial fistula. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPF-001Expanded somatic mesenchymal stromal cells (MSCs) seeded onto a decellularised human tracheal-scaffold | Other | Treatment Arm |
Primary outcome
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.
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.
4 secondary outcomes
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
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
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
Absence of other surgical interventions at 6, 9, 12, 24 and 36 months
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No. to follow
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BPF-001 in people with Bronchopleural Fistula, run by Videregen Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.