Archive for December, 2017
Gene therapy at OHSU Casey Eye Institute | Casey Eye …
Ongoing gene therapy trials open to enrollment
These studies are actively seeking new participants.
The purpose of this study is to learn about a new gene therapy that may help patients with Achromatopsia. This is the first study that aims to treat Achromatopsia disease by gene therapy. The study investigators want to find out whether it is safe for use in humans. The gene therapy is given by a surgical injection into the retina (the lining of the back of the eye that detects light) of one eye. The eye with worse vision will receive the gene therapy.
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The purpose of this study is to learn about a new gene therapy that may help patients with Achromatopsia. The study investigators want to find out whether it is safe for use in humans. The gene therapy is given by a surgical injection into the retina (the lining of the back of the eye that detects light) of one eye. The eye with worse vision will receive the gene therapy.
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The purpose of this study is to learn about a new gene therapy that may help patients with X-Linked Retinoschisis (XLRS).This is the first study that aims to treat XLRS disease by gene therapy. The study investigators want to find out whether it is safe for use in humans. The gene therapy is given by a surgical injection into the vitreous (a thick, gel-like transparent substance that fills the center of the eye) of one eye. The eye with worse vision will receive the gene therapy.
Contact 503 494-0020 or email the ORDC.
The purpose of this study is to learn about a new gene therapy being studied in patients with Retinitis Pigmentosa (RP) as a result of Usher Syndrome.This is the first study that aims to treat RP due to Usher Syndrome by gene therapy.The study investigators want to find out if UshStat is safe for use in humans.The gene therapy is given by surgical injection underneath the retina of one eye.The eye with worse vision will receive the gene therapy
Contact 503 494-0020 or email the ORDC.
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The purpose of this study is to learn about a new gene therapy that may help patients with Stargardt's Macular Degeneration (SMD). This is the first study that aims to treat Stargardt's disease by gene therapy. The study investigators want to find out whether it is safe for use in humans. The gene therapy is given by a surgical injection underneath the retina of one eye. The eye with worse vision will receive the gene therapy.
Contact 503 494-0020 or email the ORDC.
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Purpose: To evaluate the safety and dosing levels of a gene-based treatment, RetinoStat, for wet AMD. In this study, two helpful genes are delivered directly to the retina, where they "turn on" proteins that block abnormal blood vessel growth in a sustained fashion. Enrollment is completed and study patients are being followed.
Contact: Ann Lundquist, 503 494-6364.
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Gene therapy at OHSU Casey Eye Institute | Casey Eye ...
Gene Therapy Advisory Committee – Health Research Authority
If your application is for ethical approval of a gene therapy clinical trial you must apply to the Gene Therapy Advisory Committee (GTAC).
GTAC is the UK national REC for gene therapy clinical research according to regulation 14(5) of The Medicines for Human Use (Clinical Trials) Regulations 2004.
You may book applications to the following RECs:
Once a booking is accepted, you must electronically submit your application and supporting documentation on the same day. If your application is valid, you will be sent an acknowledgement within five days of receipt and arrangements subsequently made for you to attend the REC meeting.
Historically, GTAC would send applications for external peer review. In future, as with all other RECs, the responsibility for providing peer review will rest with the sponsor.
We will seek to work in partnership with other organisations to determine whether it is possible to develop some agreed standards. More information can be found here.
You are no longer required to seek pre-application regulatory advice from GTAC. The MHRA will continue to provide this service to commercial companies, and will consider requests for advice from academic researchers.
Members of the research community have requested clarity on the type of application that needs to be submitted to GTAC.
Legally, all gene therapy applications must be submitted to a GTAC that is able to transfer to other designated RECs.
To make it easier for researchers and sponsors to identify other studies needing review, other applications that involve cell therapy and/or that are submitted to the MHRA Clinical Trials Expert Advisory Group must also be submitted to GTAC.
All gene therapy and cell therapy applications for Clinical Trials Authorisation will be assessed by the MHRA and, where appropriate will now be submitted to the MHRA Clinical Trials Expert Advisory Group for review. This review will assure the RECs that appropriate scrutiny of the safety of the application has been carried out.
The REC will raise any concerns directly with the MHRA.
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Gene Therapy Advisory Committee - Health Research Authority