drugset / Trial / NCT01663116
Cx611-0101, eASCs Intravenous Administration to Refractory Rheumatoid Arthritis Patients
RandomizedParallel-groupSingle-blindTreatment
Summary
Phase Ib/IIa clinical trial of a new medicinal product of the somatic cell therapy class (eASCs). This study is designed as a multicenter, single blind, fixed dose escalation, with three treatment groups, controlled with placebo (randomization 3:1) whose target population are patients with rheumatoid arthritis refractory to at least two biologic.
Timeline
- Start
- 2011-03
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cx611 | Cell therapy | 1 cells/kg | Intravenous |
| Subject | Cx611 | Cell therapy | 2 cells/kg | Intravenous |
| Subject | Cx611 | Cell therapy | 4 cells/kg | Intravenous |