Taking the Therapy to Clinical Trials

We have now moved into the stage of the project where we are ready to initiate the safety studies necessary prior to clinical trials.  Hence, we are on track to commence human clinical trials during, we hope, the first quarter of 2011.  However, it is important to stress that the exact launch date of the trials is very much in the hands of the UK regulatory bodies, provided that they are fully satisfied with the safety study data that we are scheduled to submit at the end of 2010.  Considering that these will be the first human embryonic stem cell trials in man in the UK, the project really will be breaking new ground. 

Recent developments have revealed that there will be strict criteria for patient inclusion in the initial trials and that they will not be open to volunteers.  There is no list on which patients can record their interest in trials.  Once the initial trials are approved by the regulatory bodies they will take place at Moorfields Eye Hospital from where patients will be organised. 

Please note:  the 2011 initial clinical trials are NOT open to volunteers and there is NO LIST on which patients can record their interest in trials.

Prior to transplantation of the stem cell derived eye cells a number of clinical trials will be run to ensure that cellular replacement is feasible.

Autologous grafting in dry AMD
Initiated in summer 2000, this project extends the original trial in wet AMD, which used patients own cells to repopulate the macular with healthy RPE, in a population of patients affected by dry AMD.  As of December 2007, four patients with dry AMD have undergone grafting of autologous cells.

Autologous grafting in macular dystrophy
As with AMD, macular degeneration affects the support cells at the back of the eye.  For this reason, cellular replacement may help this clinical group.  As of October 2007 five patients with macular dystrophy were grafted with autologous cells.

How do I volunteer?

The trials detailed above are not recruiting patients.  There is no waiting list on which patients can place their name.  Any change to this will be posted on this page.