CABG-patientsPhase 1CARDIOMESH IINCT06956807
Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells
A Phase 1 study testing VB-C01 cellularised patch in people with CABG-patients and Heart Failure, run by Viscofan at 1 site in Poland.
Trial summary
The Cardiomesh II clinical trial is a phase I open label study intended to enrol 10 patients to evaluate the safety and efficacy of surgical epicardial implantation of a membrane seeded with allogeneic adipose tissue derived stem cells in patients scheduled to undergo coronary revascularisation surgery and at high… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CABG-patients, Heart Failure, Myocardial Infarction (MI)
- What is being tested?
- VB-C01 cellularised patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2025to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients planning to undergo coronary revascularisation surgery within one month of study entry.
- LVEF ≤45% by CMRI.
- History of myocardial infarction at least 3 months prior to inclusion.
- Scar covering at least 15% of the total left ventricular myocardial mass defined by late enhancement on CMRI.
Who cannot join
- Participation in another clinical trial within 30 days prior to inclusion.
- Prior treatment with cell or gene therapy.
- Be a candidate for heart transplant at the time of study entry.
- Diagnosis of acute myocardial infarction with 3 months prior to inclusion.
- Need for urgent revascularisation surgery.
- Strict contraindication for the use of CMRI (pacemaker or implantable automatic defibrillator carriers, previous reactions to gadolinium contrast, claustrophobia, cochlear implants, etc.).
Show all 17Show fewer
- Presence of uncontrolled ventricular arrhythmias (ventricular tachycardia or ventricular fibrillation) at the time of implant surgery.
- Active systemic infection.
- Women who are pregnant or breastfeeding.
- Mental disease or psychological condition that impedes the subject from understanding the nature of the protocol and granting his/her consent
- Advanced dementia according to the Barthel index.
- History of primary or acquired immunodeficiency or on immunosuppressive therapy (within 3 months prior to inclusion or if the need for immunotherapy is foreseeable at any time during the study follow up).
- Tumour disease, except that eradicated at least 5 years prior to inclusion in the study and without receiving chest radiotherapy. Completely eradicated non melanoma skin tumours (at any time) not requiring chest chemotherapy or radiotherapy are permitted.
- History of autoimmune disease.
- Stroke within 12 months prior to inclusion.
- Respiratory compromise or need for home oxygen therapy.
- Life expectancy of less than 1 year for any reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice - Ochojec, 40-635
Radoslaw Gocol, MD, +48 32 3598877, kkch@sum.edu.pl
Kowalowka Adam, MD, +48 32 3598877, kkch@sum.edu.pl
About this study
Official title: First in Human Open Label Multicentre Clinical Trial to Evaluate the Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells in Patients With Ischaemic Left Ventricular Dysfunction Scheduled to Undergo Coronary Revascularisation Surgery
- The Cardiomesh II clinical trial is a phase I open label study intended to enrol 10 patients to evaluate the safety and efficacy of surgical epicardial implantation of a membrane seeded with allogeneic adipose tissue derived stem cells in patients scheduled to undergo coronary revascularisation surgery and at high risk of developing heart failure.
- The primary objective of the study is to evaluate the safety of surgical implantation of this membrane in patients with large ischaemic myocardial scars scheduled to undergo coronary revascularisation surgery. The secondary objective is to investigate the efficacy of the above treatment in terms of reduction of scar size and ventricular function parameters.
Read the detailed description
- The clinical trial CARDIOMESH II aims to attenuate adverse remodelling of the left ventricle, which is the main cause of death in ischaemic heart disease, through the development of a new regenerative therapy consisting of the combination of allogeneic adipose derived stem cells with bovine derived collagen membranes to promote repair of damaged myocardium. This is predicted to achieve a 10% reduction in mortality related to ischaemic heart failure.
- Specifically, the working hypotheses of the project are:
- Surgical implantation of a membrane containing allogeneic adipose derived stem cells in patients with large myocardial scars scheduled to undergo coronary revascularisation surgery is technically feasible.
- Surgical implantation of a membrane containing allogeneic adipose derived stem cells in patients with large myocardial scars scheduled to undergo coronary revascularisation surgery is safe in terms of the primary objective consisting of major adverse cardiac and cerebrovascular events (MACCEs).
- Surgical implantation of the aforementioned bioengineering product is safe in terms of cardiac effects and immunological analysis.
- Surgical implantation of this cellularised membrane shows beneficial effects in terms of efficacy measured by surrogate cardiac imaging parameters.
- Designed as an international phase I clinical trial to be conducted at two sites in two European countries, the purpose of the study is to establish the basic safety parameters and to obtain preliminary efficacy data on clearly established surrogate variables to undertake future larger scale trials focused on clinical efficacy.
- Conditions
- CABG-patients, Heart Failure, Myocardial Infarction (MI)
- Being tested
- VB-C01 cellularised patch
- Keywords
- heart failure, coronary revascularisation surgery, adipose-derived stem cells, myocardial infarction
- Medical subject headings
- Heart Failure, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB-C01 cellularised patchCombination product
surgical epicardial implantation of a membrane seeded with allogeneic adipose tissue derived stem cells in patients scheduled to undergo coronary revascularisation surgery and at high risk of developing heart failure
| Study group | Role | What they receive |
|---|---|---|
| Treatment with VB-C01 | Experimental | Treatment arm in which patients will be treated with a VB-C01 cellularised patch. Receives: Combination Product: VB-C01 cellularised patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
combination of MACCEs at all follow up visits during the first year after treatment
combination of MACCEs at all follow up visits during the first year after treatment (after surgery, at 1, 3, 6, 9 and 12 months). MACCEs are defined as all cause death, myocardial infarction requiring target vessel revascularisation, hospitalisation for heart failure, cardiac tamponade or pericardial constriction, sustained ventricular tachycardia, ventricular fibrillation, and stroke.
Measured: 12 months
Secondary outcomes (17)
Safety - Composite MACCE
Composite MACCE (all cause death, myocardial infarction requiring target vessel revascularisation, hospitalisation for heart failure, cardiac tamponade or pericardial constriction, sustained ventricular tachycardia, ventricular fibrillation, and stroke) at all follow up visits during the first year after treatment (after surgery, 1, 3, 6, 9 and 12 months),
Measured: 12 months
Safety - Hematology parameters
Erythrocytes, Haemoglobin, Haematocrit, Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, Prothrombin time, APTT, INR.
Measurement of the values and evaluation of their clinical significance in case they are outside of the normal range.
Measured: 12 months
Safety - Adverse Events
Any cause adverse event at all follow up visits during the first year after treatment (after surgery, 1, 3, 6, 9 and 12 months)
Measured: 12 months
Safety - Biochemical blood parameters
Measurement of biochemistry paramenters in blood including Glucose, Creatinine, Urea, GOT, GPT, GGT, Total bilirubin, Alkaline phosphatase, Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Total proteins, Sodium, Potassium, Calcium, Chloride.
Evaluation of clinical significance in case values are out of normal range.
Measured: 12 months
Safety - New York Heart Association (NYHA) functional class
Assessment of the New York Heart Association (NYHA) functional class before surgery (the first assessment will be done during the screening process and repeated before the procedure), at 6 and 12 months after surgery.
Measured: 12 months
Safety - Minnesota Living with Heart Failure (MLHFQ) questionnaire
Minnesota Living with Heart Failure (MLHFQ) questionnaire, before surgery (the first assessment will be done during the screening process, at least one day before surgery), at 6 and 12 months after surgery.
Measured: 12 months
Safety - 6 minute walk test
The 6 minute walk test will be performed before surgery (the first assessment will be done during the screening process, at least one day before surgery), at 6 and 12 months after surgery.
Measured: 12 months
Safety - Brain natriuretic peptide curve (Nt proBNP or BNP)
Brain natriuretic peptide curve (Nt proBNP or BNP, depending on the availability at each site using the same parameter throughout the follow up of each patient). Levels will be measured during the screening process (the first assessment will be done, at least one day before surgery), on the second day after surgery and at 6 and 12 months after product administration.
Measured: 12 months
Safety - C reactive protein (CRP) levels
C reactive protein (CRP) levels will be assessed prior to surgery (the first assessment will be done during the screening process, repeated prior to surgery), at hospital discharge, and 1 month after product administration.
Measured: 1 month
Safety - Incidence of subacute pericardial inflammation or constrictive physiology
Incidence of subacute pericardial inflammation or constrictive physiology as assessed by echocardiography and cardiac magnetic resonance imaging (CMRI) at months 1, 6 and 12 after treatment. The first assessment will be done during the screening process.
Measured: 12 months
Safety - Immunological analysis
The following immunological analysis will be performed: B Lymphocytes, NK Lymphocytes (CD16+), T Lymphocytes (CD3+), Th Lymphocytes (CD4+), Activated Th Lymphocytes (CD4+DR+), Treg Lymphocytes (CD4+CD25+), Treg Lymphocytes (CD4+CD25+), Activated Treg Lymphocytes (CD4+CD25+DR+), Cytotoxic T Lymphocytes (CD8+), Activated Cytotoxic T Lymphocytes (CD8+DR+), Cytotoxic Treg Lymphocytes (CD8+CD25+), Activated Cytotoxic Treg Lymphocytes (CD8+CD25+DR+), Albumin, Alpha globulin, Beta globulin, Gamma globulin, IgG, IgM and anti-HLA antibodies (the first assessment will be done during the screening process) at discharge (at discharge excluding Serum Cytokines and anti-HLA antibodies) and 1 month after product administration.
Measured: 1 month
Efficacy - Change in scar size
Absolute change in scar size expressed as percentage of left ventricular mass (i.e. scar mass corrected for total left ventricular mass), absolute change in percentage of viable left ventricular mass (i.e. viable mass corrected for total left ventricular mass), absolute change in total scar size (expressed in grams), and absolute change in viable mass (expressed in grams).
Measured: 12 months
Efficacy - end systolic volume
Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis.
Measured: 12 months
Efficacy - end diastolic volume
Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis.
Measured: 12 months
Efficacy - ejection fraction
Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis.
Measured: 12 months
Efficacy - segmental contractility
Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis.
Measured: 12 months
Efficacy - segmental wall thickness
Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABG-patientsStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viscofan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRI Sp. z o.o., Medical University of Silesia, Clinica Universidad de Navarra, Universidad de Navarra, Hospital General Universitario Gregorio Marañon
- Responsible party
- Sponsor
- Investigators
- Radoslaw Gocol, MD, Study chair, Medical University of SilesiaJavier Bermejo, MD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956807
- Sponsor's protocol ID
- CARDIOMESH II
- Other IDs
- 2024-517738-16-00, 2022-002180-29
- Acronym
- CARDIOMESH II
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human Open Label Multicentre Clinical Trial to Evaluate the Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells in Patients With Ischaemic Left Ventricular Dysfunction Scheduled to Undergo Coronary Revascularisation Surgery
- ClinicalTrials.gov ID
- NCT06956807
- Acronym / sponsor ID
- CARDIOMESH II / CARDIOMESH II
- Conditions
- CABG-patients, Heart Failure, Myocardial Infarction (MI)
- Keywords
- heart failure, coronary revascularisation surgery, adipose-derived stem cells, myocardial infarction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ViscofanIndustry (pharma, biotech, devices)
- Collaborators
- KCRI Sp. z o.o., Medical University of Silesia, Clinica Universidad de Navarra, Universidad de Navarra, Hospital General Universitario Gregorio Marañon
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 May 2025 (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.
- The Cardiomesh II clinical trial is a phase I open label study intended to enrol 10 patients to evaluate the safety and efficacy of surgical epicardial implantation of a membrane seeded with allogeneic adipose tissue derived stem cells in patients scheduled to undergo coronary revascularisation surgery and at high risk of developing heart failure.
- The primary objective of the study is to evaluate the safety of surgical implantation of this membrane in patients with large ischaemic myocardial scars scheduled to undergo coronary revascularisation surgery. The secondary objective is to investigate the efficacy of the above treatment in terms of reduction of scar size and ventricular function parameters.
Detailed description
- The clinical trial CARDIOMESH II aims to attenuate adverse remodelling of the left ventricle, which is the main cause of death in ischaemic heart disease, through the development of a new regenerative therapy consisting of the combination of allogeneic adipose derived stem cells with bovine derived collagen membranes to promote repair of damaged myocardium. This is predicted to achieve a 10% reduction in mortality related to ischaemic heart failure.
- Specifically, the working hypotheses of the project are:
- Surgical implantation of a membrane containing allogeneic adipose derived stem cells in patients with large myocardial scars scheduled to undergo coronary revascularisation surgery is technically feasible.
- Surgical implantation of a membrane containing allogeneic adipose derived stem cells in patients with large myocardial scars scheduled to undergo coronary revascularisation surgery is safe in terms of the primary objective consisting of major adverse cardiac and cerebrovascular events (MACCEs).
- Surgical implantation of the aforementioned bioengineering product is safe in terms of cardiac effects and immunological analysis.
- Surgical implantation of this cellularised membrane shows beneficial effects in terms of efficacy measured by surrogate cardiac imaging parameters.
- Designed as an international phase I clinical trial to be conducted at two sites in two European countries, the purpose of the study is to establish the basic safety parameters and to obtain preliminary efficacy data on clearly established surrogate variables to undertake future larger scale trials focused on clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with VB-C01 | Experimental | Combination Product: VB-C01 cellularised patchTreatment arm in which patients will be treated with a VB-C01 cellularised patch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients planning to undergo coronary revascularisation surgery within one month of study entry.
- LVEF ≤45% by CMRI.
- History of myocardial infarction at least 3 months prior to inclusion.
- Scar covering at least 15% of the total left ventricular myocardial mass defined by late enhancement on CMRI.
Key exclusion criteria (17 listed)
- Participation in another clinical trial within 30 days prior to inclusion.
- Prior treatment with cell or gene therapy.
- Be a candidate for heart transplant at the time of study entry.
- Diagnosis of acute myocardial infarction with 3 months prior to inclusion.
- Need for urgent revascularisation surgery.
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 |
|---|---|---|
| VB-C01 cellularised patchsurgical epicardial implantation of a membrane seeded with allogeneic adipose tissue derived stem cells in patients scheduled to undergo coronary revascularisation surgery and at high risk of developing heart failure | Combination product | Treatment with VB-C01 |
Primary outcome
combination of MACCEs at all follow up visits during the first year after treatment
Time frame: 12 months
combination of MACCEs at all follow up visits during the first year after treatment (after surgery, at 1, 3, 6, 9 and 12 months). MACCEs are defined as all cause death, myocardial infarction requiring target vessel revascularisation, hospitalisation for heart failure, cardiac tamponade or pericardial constriction, sustained ventricular tachycardia, ventricular fibrillation, and stroke.
17 secondary outcomes
Safety - Composite MACCE
Time frame: 12 months
Safety - Hematology parameters
Time frame: 12 months
Safety - Adverse Events
Time frame: 12 months
Safety - Biochemical blood parameters
Time frame: 12 months
Safety - New York Heart Association (NYHA) functional class
Time frame: 12 months
Safety - Minnesota Living with Heart Failure (MLHFQ) questionnaire
Time frame: 12 months
Safety - 6 minute walk test
Time frame: 12 months
Safety - Brain natriuretic peptide curve (Nt proBNP or BNP)
Time frame: 12 months
Safety - C reactive protein (CRP) levels
Time frame: 1 month
Safety - Incidence of subacute pericardial inflammation or constrictive physiology
Time frame: 12 months
Safety - Immunological analysis
Time frame: 1 month
Efficacy - Change in scar size
Time frame: 12 months
Efficacy - end systolic volume
Time frame: 12 months
Efficacy - end diastolic volume
Time frame: 12 months
Efficacy - ejection fraction
Time frame: 12 months
Efficacy - segmental contractility
Time frame: 12 months
Efficacy - segmental wall thickness
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for CABG-patients
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
RecruitingPhase 3
A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.
Coronary Artery Disease (CAD), Coronary Artery Bypass Graft Surgery(CABG)
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.
Radoslaw Gocol, MD study chair
Medical University of Silesia
Javier Bermejo, MD principal investigator
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VB-C01 cellularised patch in people with CABG-patients and Heart Failure, run by Viscofan at 1 site in Poland.
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 4 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: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lluis Quintana, PhD, MBA (+49 6201 86-236, quintana@bio.viscofan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
combination of MACCEs at all follow up visits during the first year after treatment (time frame: 12 months). 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 4 May 2025.