Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
6
Countries
1
Sites
1
Patients with knee femoral cartilage isolated lesions
Key facts
- Sponsor
- Lamina Therapeutics
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2024-10-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with knee femoral cartilage isolated lesions
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10031231 | Osteochondritis dissecans | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Lamina Therapeutics
- Sponsor organisation
- Lamina Therapeutics
- Address
- 1 Rue Eugene Boeckel
- City
- Strasbourg
- Postcode
- 67000
- Country
- France
Scientific contact point
- Organisation
- Lamina Therapeutics
- Contact name
- Stephan Lemmens
Public contact point
- Organisation
- Lamina Therapeutics
- Contact name
- Stephan Lemmens
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 6 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Hopital de Hautepierre Strasbourg
Orthopedic department, 1 Place de l'Hopital, 67000, Strasbourg
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-02 | France | Acceptable with conditions 2024-10-04
|
2024-10-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-05 | France | Acceptable 2025-06-04
|
2025-06-05 |