Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease — AMSC-DSD-001  

Degenerative Disc Disease Clinical Trial

Official title: Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease to Assess the Safety and the Efficacy

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Following informed consent collection at the screening visit and verification of all inclusion and exclusion criteria, eligible patients will undergo the procedure of bone marrow cell aspiration from iliac crest for the purpose of receiving autologous multipotent mesenchymal stem cells. The cells will be cultivated for 3 passages (for 3 - 4 weeks) in order to expand them to sufficient quantity. Suspension of the cultured AMSC will then be sterilely packed and transported to the surgery site. During the posterolateral spine fusion operation, 1.5 ml of cell suspension will be mixed with 5 cc of beta-tricalcium phosphate foam (Vitoss™, Orthovita) and 3.5 ml of patient's blood, and inserted between the transverse processes of the lumbar spine.

All subjects will be hospitalized and followed up as per standard medical care rules used in the investigational site hospital for this type of intervention. ;

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

• NCT number: NCT03827096
• Study type: Interventional
• Source: Bioinova, s.r.o.
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: August 27, 2013
• Completion date: December 14, 2016