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

Bioinova

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Degenerative Disc Disease

Treatments: Drug: Suspension of human autologous MSC 3P in 1.5 ml

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03827096

AMSC-DSD-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Human AMSC (passage 3) 3P in 1.5 mL

Experimental group

Description:

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

Treatment:

Drug: Suspension of human autologous MSC 3P in 1.5 ml