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

• Status: Terminated
• Trial end date: 2016-12-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioinova, s.r.o.
• Collaborator: Department of Spine Surgery, University Hospital Motol, Prague, Czech Republilc

Criteria

Inclusion Criteria:

1. established diagnosis of spinal degenerative disease indicated for lumbar spine surgery,

2. patients indicated for fusion therapy,

3. patients between 18-55 years, both sexes,

4. patients able to provide written informed consent.

Exclusion Criteria:

1. previous lumbar spine surgery in the same segment of the spine, in order to achieve vertebral fusion,

2. osteoporosis,

3. diabetes mellitus,

4. pregnancy or breastfeeding,

5. women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners,

6. fertile men not using proven contraceptive measures including effective contraception method in their partner (established oral contraception, intrauterine device, ligation of the uterine tube),

7. coagulopathy,

8. malnutrition, primary biliary cirrhosis,

9. skin infection at the site of bone marrow aspiration or at the site of spinal fusion,

10. gastrostomy,

11. any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure, renal failure, liver failure, systemic infection, recurrent thromboembolic disease .....),

12. alcohol or drug abuse,

13. cancer (compulsory clinical oncological screening),

14. ongoing or recent (last 3 months) systemic corticosteroid or immunosuppressive therapy.