Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
1
Bilateral Limbal Stem Cell Deficiency
Key facts
- Sponsor
- Hospices Civils De Lyon
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 13 Nov 2020 → ongoing
- Decision date (initial)
- 2024-09-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513939-24-00
- EudraCT number
- 2019-003215-63
- ClinicalTrials.gov
- NCT03949881
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Bilateral Limbal Stem Cell Deficiency
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10072138 | Limbal stem cell deficiency | 100000004853 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospices Civils De Lyon
- Sponsor organisation
- Hospices Civils De Lyon
- Address
- 3 Quai Des Celestins, Bp 2251 Bp 2251
- City
- Lyon Cedex 02
- Postcode
- 69229
- Country
- France
Scientific contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Pr Carole BURILLON
Public contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Pr Carole BURILLON
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Hospices Civils De Lyon
Service d'Ophtalmologie, 5 Place D Arsonval, 69437, Lyon Cedex 03
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2020-11-13 | 2020-11-13 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-31 | France | Acceptable 2024-08-27
|
2024-09-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-25 | France | Acceptable 2024-11-18
|
2024-12-04 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-30 | France | Acceptable 2024-11-18
|
2025-04-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-03 | France | Acceptable 2025-12-08
|
2025-12-09 |