Patients with stable compensated dilatative cardiomyopathy, with maximum medical management and no further treatment option. MedDRA version: 20.0 Level: LLT Classification code 10056419 Term: Dilated cardiomyopathy System Organ Class: 100000004849
Conditions
Interventions
Product Name: CardAPcells
Product Code: CardAP-Zellen
Pharmaceutical Form: Suspension for injection
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient information procedure and signed informed consent form 2. Male and female participants at the age of 18-75 years 3. Patients with chronic (> 3 months) dilated cardiomyopathy 4. Ejection fraction (EF) = 40 % 5. NYHA II and III 6. Medication stable at least 3 months prior study enrolment 7. Heart rhythm stable at least 3 months prior to study enrolment 8. Body weight between 60-100 kg at study enrolment 9. Negative pregnancy test 10. Highly effective contraception in women (defined as pearl index =65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: 1. Atrial fibrillation 2. Severe valve defect 3. HIV 1 /2 positive 4. Lues positive 5. Active hepatitis B/C 6. Previous myocardial infarction 7. Ventricular wall thickness = 5 mm 8. Ventricular thrombus 9. NT pro BNP = 350 pg/ml 10. Pregnancy and breast feeding 11. Female patients of child-bearing potential*, unless patient is willing to use highly effective contraception** during study participation *Female patients of child-bearing potential are women who have passed menarche and are pre-menopausal or not permanantly sterilised (e.g. hysterectomy, bilateral salpingo-oophorectomy) **Highly effective contraception are methods that have a failure rate 800) 19. major surgical procedure or major injury in the last 14 days 20. body weight > 100 kg 21. BMI = 40 (morbid obesity) 22. known autoimmune diseases (e.g. lupus, multiple sclerosis) 23. diabetes type I and II (if HbA1c >7.5%) 24. hypersensitivity reactions to penicillin and aminoglycoside antibiotics (streptomycin) 25. hypersensitivity reactions to contrast media (Sonovue) 26. hypersensitivity to clemastine, other antihistamines with similar chemical structure or any of the other ingredients (water for injection; propylene glycol; ethanol; sorbitol; sodium citrate). 27. suffering from porphyria or acute porphyria in history 28. severe liver failure (transaminase 3-fold elevated; CHILD stage C) 29. severe renal insufficiency (GFR < 30 ml/min) 30. rare hereditary fructose intolerance 31. hypersensitivity to ranitidine, other H2 receptor antagonists or any of the other components (water for injection). 32. hypersensitivity to the active substance dobutamine (as hydrochloride) or any of the other components (mannitol) 33. mechanical obstruction of ventricular filling and/or discharge, such as pericardial tamponade, pericarditis constrictiva, hypertrophic obstructive cardiomyopathy, severe aortic stenosis 34. hypovolemic conditions 35. administration of MAO inhibitors 36. unwillingness to store and share pseudonymous disease data during clinical trials 37. person who is not able to recognise the nature, significance and scope of the clinical trial (AMG § 40 para. 1 sentence 3), accommodation in an institution by court order or official order (AMG § 40 para. 1 sentence 4) 38. person who is dependent on the sponsor, investigator or the Enforcement Panel (AMG § 40 para. 1 sentence 3 no. 3 b) and c) AMG in connection with para. 1.61 of the ICH/GCP guideline Topic E6)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main study objective is to investigate the safety of CardAPcells in patients suffering from dilated cardiomyopathy. Moreover, secondary parameters of the study serve to demonstrate efficacy. The evaluation of efficcy is facilitated by measures of LV-function, coinciding with an improvement of life quality, examined by specialised questionnaires and standardised clinical examination methods.;Secondary Objective: Not applicable;Primary end point(s): Primary Endpoints • Acute toxicity in the context of the CardAPcells therapy: i) Occurrence of pulmonary complications ii) Occurrence of immunological reactions leading to anaphylactic reactions, cardiovascular risk or any acute organ failure (those occur either due to immunological activity of cells or cell death including released cell content) •Chronic toxicity in the context of the CardAPcells therapy: i)Incidence of malignant diseases directly caused by the "CardAPcells" product ;Timepoint(s) of evaluation of this end point: Safety evaluation occurs during study investigation at day of cell injection day -1/0 until visit 6 (final study visit). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Maintenance and stability of cardiac output capacity i. Development of load reserves ii. Development of NYHA-class, duration of NYHA-class without deterioration of NYHA-class iii. Cardiac output during 6 min walk test at the last study investigation iv. Development of ejection fraction in silence oriented at base value during cell therapy application Quality of life • Improvement of Minnesota Living with Heart Failure Questionnaire (MLHFQ) results and SF36 at end of study investigations;Timepoint(s) of evaluation of this end point: Efficacy evaluation occurs during study investigation at day of myocard biopsy 2,5 months prior to cell injection until visit 6 (final study visit). | — |
Countries
Germany
Contacts
Public ContactDr. Marion Haag
Charité - Universitätsmedizin Berlin
Outcome results
None listed