PERFECT Study
Research type
Research Study
Full title
A multicentre observational study to assess the long-term results of participants in the EXCELLENT clinical trial
IRAS ID
343725
Contact name
David Newby
Contact email
Sponsor organisation
CellProthera SAS
Clinicaltrials.gov Identifier
2024-A00423-44, EudraCT Number
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
The aim of this study is the long-term follow up of participants that completed the EXCELLENT clinical trial. The follow-up period is expected to last 10 years. This study will provide information on the long-term safety and effectiveness of the ProtheraCytes® treatment.
This is an observational study. This means that the patients doctor or research team will only collect information about their health for the duration of the study. There will be no medical appointments. No tests will be carried out. The participant will not receive any treatment as part of the study.
Each year, the participants doctor or reasearch team at the hospital where the participant was treated will collect new information about the participants health. This information will be taken from their medical file, or requested by their doctor or reasearch team from their GP or cardiologist. The the doctor or reasearch team may also call the participants directly to ask how they are, but only with the written consent of the participant.
REC name
London - London Bridge Research Ethics Committee
REC reference
24/PR/0679
Date of REC Opinion
1 Aug 2024
REC opinion
Favourable Opinion