drugset / Trial / NCT01663116

Cx611-0101, eASCs Intravenous Administration to Refractory Rheumatoid Arthritis Patients

NCT01663116 ↗

Phase 1/2 Completed 53 enrolled Tigenix S.A.U.
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

EvaluationDrugModalityDoseRoute
Subject Cx611 Cell therapy 1 cells/kg Intravenous
Subject Cx611 Cell therapy 2 cells/kg Intravenous
Subject Cx611 Cell therapy 4 cells/kg Intravenous

Indications