Be­come study cen­ter

If you and your in­sti­tu­tion are in­ter­ested in bring­ing for­ward our in­nov­at­ive thera­peut­ic ap­proaches, and in con­trib­ut­ing with us to this ven­ture, you can con­tact us through the ded­ic­ated form on this web­site.

To be­come a study cen­ter in a clini­cal tri­al test­ing one of the ap­proaches, your in­sti­tu­tion needs to have ac­cess to sev­er­al facilities/competences briefly de­scribed be­low.

Your in­sti­tu­tion should of­fer a fully equipped oph­thal­mo­lo­gic cen­ter for ocu­lar sur­gery with ex­per­i­enced oph­thal­mic sur­geons.

The GMP-grade pro­duc­tion of cel­lu­lar stand­ard trans­plant­a­tion and Gene The­ra­py Medi­cin­al products re­quires a clean room fa­cil­ity and per­son­nel trained in ge­net­ic en­gin­eer­ing, cell and mo­lecu­lar bio­logy, as well as qual­ity con­trol.

The re­quired spe­cial equip­ment and con­sum­ables will be the Clinipor­at­orTM for cell elec­tro­por­a­tion, toge­ther with the cor­res­pond­ing mi­cro­cu­vettes (single-use) and the cu­vette hold­er, elec­tro­por­a­tion buf­fer and the plas­mid mix­ture.

In ad­di­tion, your par­ti­cip­a­tion to the clini­cal tri­al has to be ap­proved by the loc­al eth­ic­al com­mis­sion and na­tion­al reg­u­lat­ory au­thor­it­ies, for which you need to pre­pare a full dossier.

In ex­change, we will provide you sup­port in pre­par­ing dossiers for eth­ic­al and reg­u­lat­ory ap­prov­al, in ad­apt­ing our ap­proach to your in­sti­tu­tion, and in val­id­at­ing your pro­duc­tion. We of­fer study pro­to­cols and re­lated doc­u­ments, SOPs (Stand­ard Op­er­at­ing Pro­ced­ure) about product man­u­fac­ture and qual­ity con­trol, and train­ing to your per­son­nel to al­low its qual­i­fic­a­tion.

We will sup­port joint grant pro­pos­al sub­mis­sions to fin­ance the real­iz­a­tion of the tri­al in your in­sti­tu­tion.

The start of the first clini­cal study (Tar­get­AMD 1.0) is fore­seen for fall 2023 and thus, your par­ti­cip­a­tion would be pos­sible at the earli­est in sum­mer 2024.

    Pro­fes­sion
    1. Phys­i­cianSci­ent­istHealth­care pro­fes­sion­als oth­er than phys­i­cians

    1. Head (Clin­ic / Group)Seni­or (Res­id­ent / Sci­ent­ist)Res­id­ent / Stu­dentOth­er

    1. Private prac­ticePrivate hos­pit­alPub­lic or Uni­ver­sity hos­pit­alPhar­ma­ceut­ic­al com­panyOth­er


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    Your In­form­a­tion
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    5. In­form­a­tionMy or­gan­iz­a­tion is a clini­cal cen­ter in the study (I am in­vest­ig­at­or)My or­gan­iz­a­tion was a clini­cal cen­ter in the study (I was in­vest­ig­at­or)

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