Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
25
Countries
1
Sites
2
refractory Multiple Sclerosis
Key facts
- Sponsor
- Miltenyi Biomedicine GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 1 Apr 2026 → ongoing
- Decision date (initial)
- 2025-06-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
refractory Multiple Sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10028245 | Multiple sclerosis | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Miltenyi Biomedicine GmbH
- Sponsor organisation
- Miltenyi Biomedicine GmbH
- Address
- Friedrich-Ebert-Strasse 68, Moitzfeld Moitzfeld
- City
- Bergisch Gladbach
- Postcode
- 51429
- Country
- Germany
Scientific contact point
- Organisation
- Miltenyi Biomedicine GmbH
- Contact name
- Clinical Trial Desk
Public contact point
- Organisation
- Miltenyi Biomedicine GmbH
- Contact name
- Clinical Trial Desk
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 25 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Germany | 2026-04-01 | 2026-04-08 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-28 | Germany | Acceptable 2025-06-25
|
2025-06-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-09 | Germany | Acceptable 2025-11-04
|
2025-11-12 |