Non-ischemic heart failure with reduced ejection fraction
Conditions
Brief summary
The primary efficacy endpoint is change in LVEF 6 months after last C2C_ASC110 infusion compared to the patient group treated with placebo (CryoStor CS10) infusion.
Detailed description
The secondary efficacy endpoint are changes in LVESV (left ventricular end-systolic volume), LVEF and LVEDV (left ventricular end-diastolic volume) at 7 and 12 months follow-up., Other secondary efficacy endpoints: changes in; NYHA classification; 6-minute walking test; KCCQ and EQ5D5L questionnaire; additional echocardiographic measures and Pro-BNP, Safety endpoints are: incidence and severity of SARs (serious adverse reactions) and SUSARs (suspected unexpected serious adverse reactions) evaluated at 12 months follow-up
Interventions
DRUGC2C_ASC110
DRUGCryoStor® CS10 is used as placebo. CryoStor® CS10 is a freezing medium for cells that contains DMSO. It has been used for cryopreservation of C2C_ASC110 and within the formulation of C2C_ASC110 formulation as excipient.
It is serum-free
DRUGanimal component-free product. It is manufactured according to cGMP principles. It is formulated with USP-grade components to minimize variability and contains 10% DMSO.
CryoStor® 10 has been used as an excipient for cryopreservation of the EU marketed product Yescarta® EU/1/18/1299/001
DRUGa genetically modifies autologous cell-based product containing transduced T cells (0
DRUG4 -2x10^8 cells) for treatment of blood cancers. The product is also approved by US FDA and Health Canada. Thus
DRUGCryoStor® is not regarded as a novel excipient.
A further description of CryoStor® CS10 are approachable in the IMPD of C2C_ASC110.
Sponsors
Cell2Cure ApS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is change in LVEF 6 months after last C2C_ASC110 infusion compared to the patient group treated with placebo (CryoStor CS10) infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoint are changes in LVESV (left ventricular end-systolic volume), LVEF and LVEDV (left ventricular end-diastolic volume) at 7 and 12 months follow-up., Other secondary efficacy endpoints: changes in; NYHA classification; 6-minute walking test; KCCQ and EQ5D5L questionnaire; additional echocardiographic measures and Pro-BNP, Safety endpoints are: incidence and severity of SARs (serious adverse reactions) and SUSARs (suspected unexpected serious adverse reactions) evaluated at 12 months follow-up | — |
Countries
Denmark
Outcome results
None listed