Clinical trial NCT03827096: Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease
Official title: Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease to Assess the Safety and the Efficacy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Degenerative Disc Disease
Lead sponsor: Bioinova, s.r.o.
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Motol
First posted: 2019-02-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Safety: To demonstrate absence of complications at the site of spinal fusion
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy: To assess the quality of life determined by Oswestry Questionnaire.
timeFrame: 1 year
measure: Efficacy: To assess the quality of spinal fusion by X-ray imaging
timeFrame: 1 year
measure: Efficacy: To assess the quality of spinal fusion measured by computed tomography (CT).
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: