drugset / Trial / NCT03058068
Human MesenchymAl Stem Cells Infusion in Patients With Cystic Fibrosis
RandomizedParallel-groupDouble-blindTreatment
Summary
A Safety Run-In will be followed by a Double-Blinded Randomized Phase. All subjects shall meet the inclusion/exclusion criteria, and will be evaluated prior to the scheduled infusion to establish baseline. There will be 3 subjects in the safety run-in phase and 15 subjects in the double-blinded phase.
Timeline
- Start
- 2020-12
- Primary completion
- 2027-09
- Completion
- 2028-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rexlemestrocel-L | Cell therapy | 20 cells | Intravenous |
| Subject | Rexlemestrocel-L | Cell therapy | 100 cells | Intravenous |