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Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
EU CTIS ID: 2024-515708-38-01
What this study is testing
Primary objectiv is to assess safety and efficacy of Engineered Human Myocardium (EHM) in patients with terminal heart failure (HFrEF EF ≤35%) with or without RV dysfunction (TAPSE <16 mm)
- 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
- Heart failure with reduced ejection fraction (HFrEF with EF ≤ 35%) as assessed by high-resolution echocardiography and MRI or CT.
- At least one hypo- or dyskinetic segment to demark the implant target area.
- Stable disease condition allowing for an elective left-lateral mini-thoracotomy (for LV applications) or open-chest surgery (for RV applications) for a clinically indicated intervention on the LV (e.g., coronary bypass surgery, valve repair, mechanical circulatory support device implantation) with concomitant RV dysfunction, diagnosed using the Tricuspid Annular Plane Systolic Excursion (TAPSE) index <16 mm (Rudski et al. 2010).
- 18-80 years of age
- Previous implantation of an ICD or CRT-D with event recorder
- New York Heart Association (NYHA) Class III or IV under optimal medical therapy
You likely can't join if
- Contraindication to immunosuppressive drugs (e.g. known history of unresolved cancer, hepatitis B/C, HIV, HTLV1)
- Simultaneous participation in another interventional trial
- Pregnant or breastfeeding females
- Known or suspected alcohol and/or drug abuse
- Contraindication to TachoSil® (e.g. hypersenstitivity to human fibrinogen, human thrombin, horse collagen, human albumin, Riboflavin, Natriumchloride, Natriumcitrate, L-Arginin- Hydrochloride)
- Hypertrophic cardiomyopathy (HCM)
See the full eligibility criteria
- Heart failure with reduced ejection fraction (HFrEF with EF ≤ 35%) as assessed by high-resolution echocardiography and MRI or CT.
- At least one hypo- or dyskinetic segment to demark the implant target area.
- Stable disease condition allowing for an elective left-lateral mini-thoracotomy (for LV applications) or open-chest surgery (for RV applications) for a clinically indicated intervention on the LV (e.g., coronary bypass surgery, valve repair, mechanical circulatory support device implantation) with concomitant RV dysfunction, diagnosed using the Tricuspid Annular Plane Systolic Excursion (TAPSE) index <16 mm (Rudski et al. 2010).
- 18-80 years of age
- Previous implantation of an ICD or CRT-D with event recorder
- New York Heart Association (NYHA) Class III or IV under optimal medical therapy
- Willingness and ability to give written informed consent
- Female subjects 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)
- Simultaneous participation in another interventional trial
- Pregnant or breastfeeding females
- Known or suspected alcohol and/or drug abuse
- Contraindication to TachoSil® (e.g. hypersenstitivity 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
- Autoimmune disease
- 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)
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, 65+ years, 18-64 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.