Safety and Efficacy Study of Matrilin-3 Pretreated Autologous Adipose Derived Mesenchymal Stem Cells Implantation in Chronic Low Back Pain Patients With Lumbar Intervertebral Disc Degeneration

NCT ID: NCT05011474

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2022-12-31

Brief Summary

To investigate the safety and efficacy of autologous adipose-derived mesenchymal stem cell spheroids pretreated with matrillin-3 in chronic low back pain patients with lumbar intervertebral disc degeneration.

Conditions

Patients With Chronic Low Back Pain Due to Degenerative Lumbar Disc

Study Design

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

Interventions

administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3

Adipose-derived mesenchymal stem cells isolated from subject's adipose tissue are pretreated with matrillin 3 and produced in spheroid form.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male and female patients aged 19-70 years
• Among the subjects with low back pain, conventional conservative treatment is performed, but the back pain or hip pain persists for more than 3 months, and it is determined that the cause of the back pain is a degenerative disc (MRI checks for a degenerative disc)
• Has Oswestry Disability score(ODI) ≥ 30%
• Has Visual Analogue Scale(VAS) ≥ 4
• Between lumbar 1-sacral 1, Magnetic Resonance Imaging (MRI) grade according to the Pfirrmann classification is 3~4.
• Has one or two degenerative lumbar discs identified by MRI (Confirmation of low back pain due to disc through various nerve block procedures.)
• Consent was prepared for stem cell administration

Exclusion Criteria

• Patient requiring surgery due to severe pain in lower extremities due to severe nerve compression due to severe lumbar stenosis or prolapse of lumbar nucleus.
• patient with spinal instability, spondylitis, or vertebral fracture
• type 3 Modic change is in an endplate
• Patient whose disc height has decreased by more than 1/2 due to severe disc degenerative change
• Patient with severe osteoporosis (The average value of the T score in the lumbar spine bone density test is -2.5 or less)
• has undergone surgery, such as disc resection, on the disc to which the cells will be administered
• Patient who received lumbar epidural steroid injection 3 weeks before cell administration
• Pregnant or lactating women
• Among female patients who are likely to become pregnant during the clinical trial, who do not use medically acceptable methods of contraception

• medically acceptable methods of contraception: condom, Oral contraception lasting for at least 3 months, Has received an infusion pill before 3 months, using an injectable or implantable contraceptive, or installed an intrauterine contraceptive device
• has a history of psychiatry or who are currently undergoing treatment, who judged that it is difficult to proceed with the clinical trial under the judgment of the researcher
• Patient with drug or alcohol addiction who cannot understand the purpose and method of this clinical trial
• Patient who participated in other clinical trials within 3 months prior to participation in the trial
• Patient who may affect this clinical trial due to serious medical conditions (hypertension not controlled by drugs, diabetes not controlled by drugs, cirrhosis, kidney failure, tumors)
• Patient with a history of malignant tumors within the last 5 years
• has a history of administration of cell therapy products
• Other persons who have clinically significant findings deemed inappropriate for this clinical trial due to medical judgment by the person in charge of the clinical trial

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inbo Han

OTHER

Sponsor Role: lead

Responsible Party

Inbo Han

Professor, Spine Neurosurgeon, Bundang CHA Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

CHA University, CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Related Links

https://sites.google.com/view/inbolab/home

Related Info

Other Identifiers

2018-10-013

Identifier Type: -

Identifier Source: org_study_id