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Tests treatment safety and results for Heart Failure
Official title Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
ClinicalTrials.gov ID: NCT04396899
What this study is testing
What is EHM implantation?
EHM implantation is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The BioVAT-HF trial will test the hypothesis that cardiomyocyte implantation via engineered heart muscle (EHM), the proposed investigational medicinal product (IMP; designated "Biological Ventricular Assist Tissue" or BioVAT), results in sustainable remuscularization and biological enhancement of myocardial performance in the failing heart. EHM are constructed from defined mixtures of induced pluripotent stem cell (iPSC)-derived cardiomyocytes and stromal cells in a bovine collagen type I hydrogel.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Symptomatic heart failure (NYHA II-IV) with reduced ejection fraction (HFrEF with LVEF ≤35%) as assessed by echocardiography.
- Patients on guideline-directed medical therapy
- NT-proBNP \>300 pg/mL for patients in sinus rhythm or \>900 pg/mL if in atrial fibrillation
- History of previous heart failure hospitalization in the past 12 months
- At least one hypo- or dyskinetic segment or dilated heart chamber to demark the implant target area
You likely can't join if
- Contraindication to immunosuppressive drugs (e.g. known history of unresolved cancer, hepatitis B/C, HIV, HTLV1)
- Contraindication to TachoSil® (e.g. hypersensitivity to human fibrinogen, human thrombin, horse collagen, human albumin, Riboflavin, Natriumchloride...
- Hypertrophic cardiomyopathy (HCM)
- Terminal kidney failure (stage 4; GFR \<30 ml/min) at the time of enrolment
- Terminal liver failure (Child-Pugh stage C; score \>10) at the time of enrolment
- History of disabling stroke
See the full eligibility criteria
- Symptomatic heart failure (NYHA II-IV) with reduced ejection fraction (HFrEF with LVEF ≤35%) as assessed by echocardiography.
- Patients on guideline-directed medical therapy
- NT-proBNP \>300 pg/mL for patients in sinus rhythm or \>900 pg/mL if in atrial fibrillation
- History of previous heart failure hospitalization in the past 12 months
- At least one hypo- or dyskinetic segment or dilated heart chamber to demark the implant target area
- (A) Stable disease condition allowing for an elective left-lateral mini-thoracotomy (for LV applications) or (B) open-chest surgery (for RV applications) for a clinically indicated intervention on the LV (e.g., coronary...
- 18-80 years of age
- Willingness and ability to give written informed consent
- Female people of childbearing potential must agree to use acceptable method(s) of contraception for the full study duration.
- Contraindication to immunosuppressive drugs (e.g. known history of unresolved cancer, hepatitis B/C, HIV, HTLV1)
- Contraindication to TachoSil® (e.g. hypersensitivity to human fibrinogen, human thrombin, horse collagen, human albumin, Riboflavin, Natriumchloride, Natriumcitrate, L-Arginin-Hydrochloride)
- Hypertrophic cardiomyopathy (HCM)
- Terminal kidney failure (stage 4; GFR \<30 ml/min) at the time of enrolment
- Terminal liver failure (Child-Pugh stage C; score \>10) at the time of enrolment
- History of disabling stroke
- Reduced life expectancy in the short term due to non-cardiac disease
- Any condition that excludes adherence to study protocol (in particular lack of adherence to prescribed medication)
- Simultaneous participation in another treatment trial
- Pregnant or breastfeeding females
- Known or suspected alcohol and/or drug abuse
The study team makes the final eligibility decision.
Where it's taking place
- Göttingen, Lower Saxony, Germany
- Bad Oeynhausen, North Rhine-Westphalia, Germany
- Lübeck, Schleswig-Holstein, Germany
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 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Göttingen, Lower Saxony, Germany; Bad Oeynhausen, North Rhine-Westphalia, Germany; Lübeck, Schleswig-Holstein, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.