Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
NCT ID: NCT04396899
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
53 participants
INTERVENTIONAL
2020-02-03
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EHM Implantation
All patients will receive EHM implant
EHM implantation
Implantation of EHM on dysfunctional left or right ventricular myocardium in patients with HFrEF (EF \<35%).
Interventions
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EHM implantation
Implantation of EHM on dysfunctional left or right ventricular myocardium in patients with HFrEF (EF \<35%).
Eligibility Criteria
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Inclusion Criteria
2. No realistic chance or not eligible for heart transplantation
3. At least one hypo- or dyskinetic segment to demark the implant target area
4. 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) with concomitant RV dysfunction, diagnosed using the Tricuspid Annular Plane Systolic Excursion (TAPSE) index \<16 mm (Rudski et al. 2010).
5. 18-80 years of age
6. Previous implantation of an ICD or CRT-D with event recorder
7. New York Heart Association (NYHA) Class III or IV under optimal medical therapy
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
2. Alloimmunisation against EHM implant cells
3. Hypertrophic cardiomyopathy (HCM)
4. Terminal kidney failure (stage 4; GFR \<30 ml/min)
5. Terminal liver failure
6. Autoimmune disease
7. History of stroke
8. Reduced life expectancy in the short term due to non-cardiac disease
9. Simultaneous participation in another interventional trial
10. Pregnant or breastfeeding females
11. Known or suspected alcohol and/or drug abuse
18 Years
80 Years
ALL
No
Sponsors
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Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
OTHER
University Medical Center Freiburg
OTHER
Repairon GmbH
UNKNOWN
University Medical Center Goettingen
OTHER
Responsible Party
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Karsten Gavenis
on behalf of Principal Investigator Prof. Seidler and Study Director Prof. Zimmermann
Principal Investigators
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Tim Seidler, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Goettingen
Wolfram-Hubertus Zimmermann, Prof.
Role: STUDY_DIRECTOR
University Medical Center Goettingen
Locations
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University Medical Center Göttingen
Göttingen, Lower Saxony, Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, Germany
University Medical Center Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Countries
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Central Contacts
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Facility Contacts
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Tim Seidler, Prof.
Role: primary
Jan Gummert, Prof.
Role: primary
Stephan Ensminger, Prof.
Role: primary
Other Identifiers
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02289
Identifier Type: -
Identifier Source: org_study_id
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