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Viable T-cells

ATIR101

Extended indication Adjunctive treatment in haematopoietic stem cell transplantation (HSCT) for a malignant disease.
Therapeutic value No judgement

Product

Active substance Viable T-cells
Domain Oncology and Hematology
Main indication Haemophilia
Extended indication Adjunctive treatment in haematopoietic stem cell transplantation (HSCT) for a malignant disease.
Proprietary name ATIR101
Manufacturer Kiadis
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks T-lymphocytes enriched leukocyte preparation depleted ex vivo of host host-alloreactive T cells using photodynamic treatment.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date June 2017
Expected Registration April 2018
Orphan drug Yes

Therapeutic value

Therapeutic value No judgement
Duration of treatment Average 42 day / days
Dosage per administration 2x10^6 cellen/kg
References Clinical trial NCT02500550
Additional remarks Twee intraveneuse infusies van 2x10^6 T-cellen/kg, 42 dagen na elkaar.

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.