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Allogenic immunomodulatory progenitor cells

Heartcel

Extended indication End-stage heart failure in patients with coronary artery congenital malformation - adjunctive therap
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Allogenic immunomodulatory progenitor cells
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other medication for cardiovascular diseases
Extended indication End-stage heart failure in patients with coronary artery congenital malformation - adjunctive therapy in patients requiring coronary artery bypass graft.
Proprietary name Heartcel
Manufacturer Cell Therapy
Mechanism of action Allogeneic modified cell therapy
Route of administration Intracardiac
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks CD antigen modulator

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date 2022
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De fase 2 studie is positief maar nog niet doorslaggevend.
Duration of treatment one-off
References NCT03515291; expertopinie

Expected patient volume per year

References Van der Bom et al. Am Heart J. 2012 Oct;164(4):568-75; www.volksgezondheidenzorg.info.
Additional remarks De prevalentie van het aantal personen met een aangeboren hartafwijking is in internationaal vergelijkend onderzoek voor Nederland geschat op 32 per 10.000 volwassenen. Dat komt neer op ongeveer 42.200 volwassenen (>18 jaar). Daarbij moeten ongeveer 18x1.250= 22.500 gevallen bij jongeren (0-18 jaar) worden opgeteld. De totale schatting komt dan op ongeveer 65.000 Nederlanders met een aangeboren hartafwijking. Het genoemde onderzoek gaf aan dat er binnen deze groep sprake is van 5% zeer ernstige, 36% matig ernstige en 58% lichtere hartafwijkingen.

Expected cost per patient per year

Additional remarks Meerkosten

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.