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Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells

ConditionsCABG-patientsHeart FailureMyocardial Infarction (MI)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorViscofan

About this trial

* 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • VB-C01 cellularised patch

    Combination 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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Treatment with VB-C01Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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),

Time frame
12 months
2

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.

Time frame
12 months
3

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)

Time frame
12 months
4

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.

Time frame
12 months

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach Status unavailable 40-635, Katowice - OchojecPolandPoland

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Viscofan

Lead sponsor

KCRI Sp. z o.o.

Collaborator

Medical University of Silesia

Collaborator

Clinica Universidad de Navarra, Universidad de Navarra

Collaborator

Hospital General Universitario Gregorio Marañon

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: