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

NCT ID: NCT03827096

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-27
• Study Completion Date: 2016-12-14

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.

Conditions

Degenerative Disc Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Human AMSC (passage 3) 3P in 1.5 mL

Patient receiving the investigational medicinal product - suspension of human autologous MSC 3P in 1.5 mL

Group Type: EXPERIMENTAL

Suspension of human autologous MSC 3P in 1.5 ml

Intervention Type: DRUG

During the posterolateral spine fusion operation, 1.5 ml of cell suspension was mixed with 5cc of beta-tricalcium phosphate foam and 3.5 ml of patient's blood, and inserted between the right transverse processes of the lumbar spine.

Interventions

Suspension of human autologous MSC 3P in 1.5 ml

During the posterolateral spine fusion operation, 1.5 ml of cell suspension was mixed with 5cc of beta-tricalcium phosphate foam and 3.5 ml of patient's blood, and inserted between the right transverse processes of the lumbar spine.

Intervention Type: DRUG

Other Intervention Names

hAMSC

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Motol

OTHER

Sponsor Role: collaborator

Bioinova, s.r.o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

AMSC-DSD-001

Identifier Type: -

Identifier Source: org_study_id