NCT04396899 Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
| NCT ID | NCT04396899 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Medical Center Goettingen |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 53 participants |
| Start Date | 2020-02-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 53 participants in total. It began in 2020-02-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Comprehensive preclinical testing confirmed the rationale for the clinical translation of the myocardial remuscularization strategy by EHM implantation. The patient target population for EHM therapy is patients suffering from advanced heart failure with reduced ejection fraction (HFrEF; EF: ≤35%) and no realistic option for heart transplantation.
Eligibility 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
Contact & Investigator
Tim Seidler, Prof.
PRINCIPAL INVESTIGATOR
University Medical Center Goettingen
Frequently Asked Questions
Who can join the NCT04396899 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04396899 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04396899 currently recruiting?
Yes, NCT04396899 is actively recruiting participants. Contact the research team at sekretariat.pharma@med.uni-goettingen.de for enrollment information.
Where is the NCT04396899 trial being conducted?
This trial is being conducted at Göttingen, Germany, Bad Oeynhausen, Germany, Lübeck, Germany.
Who is sponsoring the NCT04396899 clinical trial?
NCT04396899 is sponsored by University Medical Center Goettingen. The principal investigator is Tim Seidler, Prof. at University Medical Center Goettingen. The trial plans to enroll 53 participants.
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