drugset / Trial / NCT03827096
Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease
NaSingle-groupOpen-labelTreatment
Summary
Subjects in whom a posterolateral fusion surgery has been planned and who meet the inclusion and exclusion criteria were proposed to receive a single-dose AMSC treatment, in order to assess its safety and efficacy on posterolateral interbody fusion. After the surgery, the subjects were followed up as out-patients during 5 study visits for 12 months in total.
Timeline
- Start
- 2013-08-27
- Primary completion
- 2016-12-14
- Completion
- 2016-12-14
Outcome
Outcome not reported
Stopped: “Primary endpoint (Safety) has been achieved”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AMSC | Cell therapy | 1.5 ml | Other |