drugset / Trial / NCT03827096

Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease

NCT03827096 ↗

Phase 1/2 Terminated 10 enrolled Bioinova, s.r.o. University Hospital, Motol · collab
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

EvaluationDrugModalityDoseRoute
Subject AMSC Cell therapy 1.5 ml Other