drugset / Trial / NCT02809781
A Pilot Study of MSCs Iufusion and Etanercept to Treat Ankylosing Spondylitis
Phase 2/3
Unknown
250 enrolled
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Nanfang Hospital, Southern Medical University · collabSecond Affiliated Hospital of Guangzhou Medical University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and clinical effect of mesenchymal stem cells (MSCs) derived from human bone marrow at a dose of 1.0E+6 MSC/kg in subject for the therapy of Ankylosing spondylitis (AS) and to compare the efficacy of MSCs and Etanercept to treat this disease.
Timeline
- Start
- 2016-06
- Primary completion
- 2018-08
- Completion
- 2018-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |
| Subject | mesenchymal stem cells | Cell therapy | 1e+06 cells/kg | Intravenous |