Using engineered heart muscle to treat advanced heart failure
Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
This study is testing if implanting engineered heart muscle can help people with advanced heart failure who aren't eligible for a heart transplant feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Medical Center Goettingen Academic / other |
| Locations | 3 sites (Göttingen, Lower Saxony and 2 other locations) |
| Trial ID | NCT04396899 on ClinicalTrials.gov |
What this trial studies
The BioVAT-HF trial aims to evaluate the safety and efficacy of engineered heart muscle (EHM) derived from induced pluripotent stem cells for patients with advanced heart failure and reduced ejection fraction. This innovative approach involves implanting EHM into the failing heart to promote remuscularization and enhance myocardial performance. The study targets patients who are not candidates for heart transplantation and have specific heart function criteria. Comprehensive preclinical testing has laid the groundwork for this clinical application.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with advanced heart failure (HFrEF) and no realistic option for heart transplantation.
Not a fit: Patients with heart failure who are eligible for heart transplantation or have other severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and quality of life for patients with terminal heart failure.
How similar studies have performed: While the approach of using engineered heart muscle is innovative, similar strategies in cardiac regeneration have shown promise in preclinical studies, though clinical applications are still emerging.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Symptomatic heart failure (NYHA II-IV) with reduced ejection fraction (HFrEF with LVEF ≤35%) as assessed by echocardiography. 2. Patients on guideline-directed medical therapy 3. NT-proBNP \>300 pg/mL for patients in sinus rhythm or \>900 pg/mL if in atrial fibrillation 4. History of previous heart failure hospitalization in the past 12 months 5. At least one hypo- or dyskinetic segment or dilated heart chamber to demark the implant target area 6. (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 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). 7. 18-80 years of age 8. Willingness and ability to give written informed consent 9. Female subjects of childbearing potential must agree to use acceptable method(s) of contraception for the full study duration. Exclusion Criteria: 1. Contraindication to immunosuppressive drugs (e.g. known history of unresolved cancer, hepatitis B/C, HIV, HTLV1) 2. Contraindication to TachoSil® (e.g. hypersensitivity to human fibrinogen, human thrombin, horse collagen, human albumin, Riboflavin, Natriumchloride, Natriumcitrate, L-Arginin-Hydrochloride) 3. Hypertrophic cardiomyopathy (HCM) 4. Terminal kidney failure (stage 4; GFR \<30 ml/min) at the time of enrolment 5. Terminal liver failure (Child-Pugh stage C; score \>10) at the time of enrolment 6. History of disabling stroke 7. Reduced life expectancy in the short term due to non-cardiac disease 8. Any condition that excludes adherence to study protocol (in particular lack of adherence to prescribed medication) 9. Simultaneous participation in another interventional trial 10. Pregnant or breastfeeding females 11. Known or suspected alcohol and/or drug abuse
Where this trial is running
Göttingen, Lower Saxony and 2 other locations
- University Medical Center Göttingen — Göttingen, Lower Saxony, Germany (Recruiting)
- Herz- und Diabeteszentrum Nordrhein-Westfalen — Bad Oeynhausen, North Rhine-Westphalia, Germany (Not_yet_recruiting)
- University Medical Center Schleswig-Holstein — Lübeck, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Principal investigator: Tim Seidler, Prof. — University Medical Center Goettingen
- Study coordinator: Wolfram-Hubertus Zimmermann, Prof.
- Email: sekretariat.pharma@med.uni-goettingen.de
- Phone: +49 551 / 3965781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.