drugset / Trial / NCT05093166
Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure
Phase 1/2
Terminated
1 enrolled
Holostem s.r.l.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · collabUniversity of Modena and Reggio Emilia · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this trial is to assess the safety and efficacy of Holour in patients suffering from hypospadias treatment failure. Holour is intended for urethral replacement and is made from ex vivo expanded autologous oral mucosal cells including stem cells.
Timeline
- Start
- 2021-11-26
- Primary completion
- 2022-12-12
- Completion
- 2022-12-12
Outcome
Outcome not reported
Stopped: “Due to the current re-organization at the Sponsor site”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Holour | Cell therapy | — | Other |