Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
10
Countries
1
Sites
1
Ischaemic cardiomyopathy
Key facts
- Sponsor
- Cell Therapy Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 30 Jul 2021 → 1 Jan 2026
- Decision date (initial)
- 2024-12-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518524-69-00
- EudraCT number
- 2020-002717-18
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Ischaemic cardiomyopathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10048858 | Ischaemic cardiomyopathy | 100000004849 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cell Therapy Limited
- Sponsor organisation
- Cell Therapy Limited
- Address
- Celixir House, Stratford Business And Technology Park, Banbury Road Stratford Business And Technology Park Banbury Road
- City
- Stratford-Upon-Avon
- Postcode
- CV37 7GZ
- Country
- United Kingdom
Scientific contact point
- Organisation
- Cell Therapy Limited
- Contact name
- Sabena Sultan
Public contact point
- Organisation
- Cell Therapy Limited
- Contact name
- Andy Hodges
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Semmelweis University
Heart and Vascular Centre, Varosmajor Utca 68, Kerulet, Budapest XII
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 |
|---|---|---|---|---|---|
| Hungary | 2021-07-30 | 2021-07-30 | 2023-04-19 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-61845
- Halt date
- 2023-04-19
- Member states concerned
- Hungary
- Publication date
- 2024-12-11
- Reason
- Sponsor decision
- Explanation
- Sponsor notified Hungarian agency on 19Apr2023 that the clinical trial will not be recruiting subjects temporarily to allow for the manufacture of new drug. If you require any further information, please do not hesitate to contact us.
- Follow-up measures
- Study will be resumed once product is available. Patients are not on active treatment.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-06 | Hungary | Acceptable 2024-11-29
|
2024-12-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-13 | Hungary | Acceptable 2025-03-13
|
2025-04-11 |