RAFT
Research type
Research Study
Full title
First in human phase I/II clinical trial of RAFT for aniridia related keratopathy
IRAS ID
269184
Contact name
Sajjad Ahmad
Contact email
Sponsor organisation
Comprehensive Clinical Trials unit at UCL
Eudract number
2019-002371-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 4 months, 0 days
Research summary
The RAFT trial is a first in human trial of a novel cellular therapy called RAFT-OS (Real Architecture for 3D Tissues Ocular Surface) developed and manufactured by Cells for Sight Stem Cell Therapy Research Unit at UCL institute of Ophthalmology.
The aim of the trial is to investigate if RAFT-OS is a safe and effective alternative treatment for patients with aniridia related keratopathy (ARK) in 21 patients. ARK is a complication of aniridia, which is a genetic eye condition present from birth.RAFT-OS is an artificial tissue, populated with limbal epithelial cells and stromal cells. The source of the adult limbal and stromal cells is from donated human corneas from the NHS blood and Transplant, Tissue and Eye services Liverpool.
Participants will commence on 3 months of immune suppression therapy to prepare for the transplantation of RAFT-OS. The product will then be transplanted into the participants worst affected eye. Following surgery participants will be allowed to go home the following day, after the day 1 eye examination. Participants will then be followed up closely for the first 4 weeks following surgery for signs of infection or other complications. If there are no serious events, the next participant will be treated with RAFT-OS.
The trial team will regularly follow participants after transplantation for 12 months, with detailed review of symptoms, investigations such as digital photography of the eye and examinations of the surface of the eye.
Participants will be required to stay on the immune suppression therapy for the duration of the trial.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0020
Date of REC Opinion
20 Apr 2021
REC opinion
Further Information Favourable Opinion