|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 January 2021 |
|
Main ID: |
NCT02941991 |
|
Date of registration:
|
20/10/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Follow up Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (hESC-RPE) Cells in Patients With Stargardt's Macular Dystrophy (SMD)
|
|
Scientific title:
|
Follow-up to 5 Years of a Phase I/II, Open-Label, Multi-Center, Prospective Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (hESC-RPE) Cells in Patients With Stargardt's Macular Dystrophy (SMD) |
|
Date of first enrolment:
|
January 16, 2013 |
|
Target sample size:
|
12 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02941991 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
Medical Director |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Astellas Institute for Regenerative Medicine |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Must have been treated with hESC-RPE cell transplant in the core protocol.
- Able to understand and willing to sign the informed consent to participate in the
follow-up study.
Exclusion Criteria:
- There are no exclusion criteria
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Stargardt's Macular Dystrophy
|
|
Intervention(s)
|
|
Biological: hESC-RPE
|
|
Primary Outcome(s)
|
|
Safety assessed by Adverse Events (AEs) of special interest in regards to the investigational product
[Time Frame: 4 years]
|
|
Secondary Outcome(s)
|
|
Incidence of graft failure or rejection
[Time Frame: 4 years]
|
|
Number of patients with changes in ocular examinations or images
[Time Frame: 4 years]
|
|
Secondary ID(s)
|
|
ACT-hESC-RPE-SMD-01FU EU
|
|
2012-002827-14
|
|
7316-CL-0006
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|