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A Phase I-IIa Trial on the Safety and Preliminary Effectiveness of Intramyocardial Injection of Allogeneic Cardiac Atrial Stem Cells for the Treatment of Heart Failure
EU CTIS ID: 2024-517031-51-00
What this study is testing
To evaluate the safety of per operative direct intramyocardial injection of allogeneic cardiac atrial appendage stem cells by determining Major Adverse Cardiac Events (MACE): Death and cause of death Re-admissions and cause of re-admission Myocardial infarction Tumour formation
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Any subject meeting all of the following inclusion criteria and verified by the Investigator during the screening period, i.e. at visits 1 and 2, will be considered acceptable for trial inclusion.
- - Safety laboratory test results and pre-surgery serology are clinically acceptable to undergo surgery at Visits 1 and 2.
- - Women of childbearing potential (WOCBP) including peri-menopausal women who have had a menstrual period within 1 year have to have a negative pregnancy test. Results must be available and negative for the subject to be entered in the trial.
- - WOCBP have to use an effective method of birth control 2 months prior to trial entry or to surgical intervention date and throughout the trial duration (defined as a method which results in a failure rate of less than 1% per year).
- - Subject has understood and accepted to participate in the trial according to all trial procedures by signing the approved informed consent.
- - Male or female subjects aged >18
You likely can't join if
- - Non-cardiovascular disease with life expectancy of less than 1 year
- - NYHA class IV congestive heart failure.
- - Evidence of tumour on screening chest/abdominal/pelvic examination.
- - Subject is on a transplant list or having received a solid organ transplant at any point in the past.
- - Pregnant or breast-feeding woman.
- - Involved in or planning to engage in litigation related health problems.
See the full eligibility criteria
Who can join
- - Any subject meeting all of the following inclusion criteria and verified by the Investigator during the screening period, i.e. at visits 1 and 2, will be considered acceptable for trial inclusion.
- - Safety laboratory test results and pre-surgery serology are clinically acceptable to undergo surgery at Visits 1 and 2.
- - Women of childbearing potential (WOCBP) including peri-menopausal women who have had a menstrual period within 1 year have to have a negative pregnancy test. Results must be available and negative for the subject to be entered in the trial.
- - WOCBP have to use an effective method of birth control 2 months prior to trial entry or to surgical intervention date and throughout the trial duration (defined as a method which results in a failure rate of less than 1% per year).
- - Subject has understood and accepted to participate in the trial according to all trial procedures by signing the approved informed consent.
- - Male or female subjects aged >18
- - Presence of a documented myocardial infarction due to coronary artery atherosclerotic disease as evidenced by conventional ECG criteria
- - An area of regional dysfunction, i.e. hypokinetic, akinetic or dyskinetic as assessed by echocardiography, ventriculography or MRI-scan.
- - The evidence of scar tissue on MRI-scan as shown by (gadolinium) delayed enhancement.
- - Left ventricular ejection fraction of ≥ 25% and ≤ 45% as determined by clinically indicated assessment of cardiac function (echocardiogram, X-ray, ventriculography, CT and/or MRI).
- - Need for revascularization including the infarcted area by CABG. If no further revascularization is clinically indicated at the time the patient is assessed for participation in the clinical trial this will be determined by a cardiologist who is not an investigator. No further revascularization may be indicated by no arteries with significant stenosis, adequate result of prior PCI, location and extent of any stenosis not suitable for angioplasty.
- - Ability to provide informed consent and follow-up with protocol procedures. Subject is, in the Investigator’s opinion, psychosocially, mentally and physically able to fully comply with this protocol, including the postoperative regimen and follow-up visits.
What rules you out
- - Non-cardiovascular disease with life expectancy of less than 1 year
- - NYHA class IV congestive heart failure.
- - Evidence of tumour on screening chest/abdominal/pelvic examination.
- - Subject is on a transplant list or having received a solid organ transplant at any point in the past.
- - Pregnant or breast-feeding woman.
- - Involved in or planning to engage in litigation related health problems.
- - Subject is a prisoner (incarcerated).
- - Subject previously received a cellular therapy (at any point in time).
- - Subject was exposed to therapy for a malignancy or pre-malignant entity, and not confirmed disease-free for 5 years or more.
- - Any clinically relevant chronic disease associated with renal or hepatic insufficiency or any chronic disease of such severity that surgery could be detrimental to the survival of the subject.
- - Any other illness which might reduce life expectancy to less than 2 years from screening.
- - Contra indications to MRI, including prior (MRI non-compatible) ICD placement, estimated glomerular filtration rate less than 50 ml per minute, known reaction to gadolinium, claustrophobia, MRI non-compatible pacemaker and cochlear implant. History of possible presence of ferromagnetic material including programmable shunt, penile prosthesis, intrauterine device, bullets, tattoos, artificial limb, blood vessel coil and tissue expander may require special screening.
- - Subject is on chronic immunosuppressive therapy (immunosuppressants or immunotherapy) due to inflammatory or systemic disease.
- - Subject has a history of any autoimmune disease such as systemic lupus erythematosus, Addison's disease, active Crohn's disease, or rheumatoid arthritis.
- - History of cardiac tumour or cardiac tumour demonstrated on MRI.
- - Patients in whom revascularisation of the infarct-related artery is technically not possible
- - Current alcohol or drug abuse because of anticipated difficulty in complying with protocol related procedures.
- - Abnormal liver function (GPT > 3 times the upper reference range) and/or haematology (hematocrit < 25%, WBC < 3000, platelets < 100000) studies without a reversible, identifiable cause.
- - Subject has compromised renal function as reflected by a serum creatinine level >3.0 mg/dL (>0.265 mmol/l) or is currently on dialysis.
- - Ventricular tachycardia or fibrillation not associated with an acute ischemic episode.
- - Symptomatic ventricular tachyarrhythmia complicating the index infarction.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.