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Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue

Alofisel / Cx601

Extended indication Treatment of complex perianal fistula(s) in adult patients with non-active / mildly active luminal C
Therapeutic value Possible added value

Product

Active substance Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue
Domain Chronic immune diseases
Main indication Bowel diseases
Extended indication Treatment of complex perianal fistula(s) in adult patients with non-active / mildly active luminal Crohn’s disease, when fistula(s) have shown an inadequate response to at least one conventional or biologic therapy.
Proprietary name Alofisel / Cx601
Manufacturer Takeda
Route of administration Intralesional
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Betreft stamcelpreparaat.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date April 2016
Expected Registration February 2018
Orphan drug Yes
Additional remarks Positieve CHMP opinie december 2017. Advanced therapy medicinal product.

Therapeutic value

Current treatment options Fabrikant: Chirurgie, medische ingrepen en/of anti-TNF
Therapeutic value Possible added value
Substantiation Als anti-TNF niet helpt dan kan dit een belangrijke bijdrage leveren en voor meer QOL zorgen.
Duration of treatment Not found
Frequency of administration 1 times a day
Dosage per administration Fabrikant: 1 toediening van 120 miljoen cellen
References Fabrikant; Panés J, et al. Lancet. 2016;388:1281-90
Additional remarks Dosering zoals in de ADMIRE-CD studie.

Expected patient volume per year

Additional remarks Inschatting varieert: Beperkt aantal patienten, alleen als het invaliderend is? Of juist veel (39% van alle ZvC patienten heeft last van fistels). Fabrikant: Onbekend, reeds communicatie met VWS hierover.

Expected cost per patient per year

Cost 20,000.00 - 40,000.00
Additional remarks De verwachting is dat het duur zal zijn, eenmalige toediening.

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.