Spinal degenerative disease MedDRA version: 17.0 Level: LLT Classification code 10070241 Term: Degenerative disc disease System Organ Class: 100000004859
Conditions
Sponsors
Bioinova, s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this trial, patients will have to meet following 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria shall not be allowed to participate in this study: 1. previous lumbar spine surgery, 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 (established oral contraception, intrauterine device, ligation of the uterine tube) in their partner, 7. coagulopathy, 8. malnutrition, primary biliar 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, reccurent thromboembolic disease .....), 12. alcohol or drug abuse, 13. cancer (compulsory clinical oncological screening), 14. ongoing and recent (last 3 months) systemic corticosteroid or immunosuppressive therapy.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the quality of life measured by Oswestry Questionnaire and the quality of fusion measured by dynamic X-rays and CT scan .;Timepoint(s) of evaluation of this end point: 3 months and 12 months after the surgery and AMSC application. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety: To assess an absence of complications at the site of spinal fusion. Efficacy: To assess the quality of spinal fusion measured according to Oswestry Questionnaire, dynamic X-rays and CT scan. ;Secondary Objective: Safety: Incidence of other treatment-emergent adverse events. Overall safety.;Primary end point(s): Safety: To assess an absence of complications at the site of spinal fusion.;Timepoint(s) of evaluation of this end point: 12 months after the surgery and AMSC application. | — |
Countries
Czech Republic
Contacts
Public ContactHeadquarters
Bioinova, s.r.o.
Outcome results
None listed