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

NCT03827096 | Terminated Phase 1

• 1 other identifier: AMSC-DSD-001
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Safety: To demonstrate absence of complications at the site of spinal fusion

  Complications at the site of spinal fusion and other treatment-related adverse events will be recorded in ten patients at Visits I through VII. All adverse events (AEs) will be classified by seriousness, severity and relationship to hAMSC application. All AEs will be collected as symptoms spontaneously reported by the patient, clinically relevant changes and abnormalities observed by the Investigator (clinically significant laboratory measurements confirmed by repeated measurement, results of physical examinations) Intensity The following 3-point rating scale will be used for rating of the intensity of each AE: Mild: Awareness of signs or symptoms, but no disruption of usual activity Moderate: Event sufficient to affect usual activities (disturbing) Severe: Inability to work or perform usual activities (unacceptable)

  1 year

Secondary Outcomes (3)

• Efficacy: To assess the quality of life determined by Oswestry Questionnaire.

  1 year

• Efficacy: To assess the quality of spinal fusion by X-ray imaging

  1 year

• Efficacy: To assess the quality of spinal fusion measured by computed tomography (CT).

  1 year

Study Arms (1)

Human AMSC (passage 3) 3P in 1.5 mL

EXPERIMENTAL

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

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

Interventions

Suspension of human autologous MSC 3P in 1.5 ml 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.

Also known as: hAMSC

Human AMSC (passage 3) 3P in 1.5 mL

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• established diagnosis of spinal degenerative disease indicated for lumbar spine surgery,
• patients indicated for fusion therapy,
• patients between 18-55 years, both sexes,
• patients able to provide written informed consent.

You may not qualify if:

• previous lumbar spine surgery in the same segment of the spine, in order to achieve vertebral fusion,
• osteoporosis,
• diabetes mellitus,
• pregnancy or breastfeeding,
• 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,
• fertile men not using proven contraceptive measures including effective contraception method in their partner (established oral contraception, intrauterine device, ligation of the uterine tube),
• coagulopathy,
• malnutrition, primary biliary cirrhosis,
• skin infection at the site of bone marrow aspiration or at the site of spinal fusion,
• gastrostomy,
• 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 .....),
• alcohol or drug abuse,
• cancer (compulsory clinical oncological screening),
• ongoing or recent (last 3 months) systemic corticosteroid or immunosuppressive therapy.

Sponsors & Collaborators

• Bioinova, s.r.o.: lead
• University Hospital, Motol: collaborator

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: February 1, 2019
• Study Start: August 27, 2013
• Primary Completion: December 14, 2016
• Study Completion: December 14, 2016
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share