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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Patients With Chronic Low Back Pain Due to Degenerative Lumbar Disc

Intervention / Treatment
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* Biological: administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This clinical trial is a Phase 1/2a, open and researcher-led clinical trial. Subjects will be enrolled in succession, signed informed consent, and administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3 to each eligible subject meeting all selection criteria.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Adverse reaction and serious adverse reaction evaluation 2) laboratory inspection 3) Vital signs 4) Biochemical examination 5) Lumbar MRI 6) Monitoring systemic infection | It will be considered safe and tolerated in the absence of the following: Grade 3 (NCI grading system) or higher adverse reactions related to cell products Any evidence that the cells are contaminated with infectious substances Any evidence that cells show tumorigenic potential | During Clinical Trial Period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmation of the degree of pain improvement in VAS | on a scale of 0 to 10, with 0 meaning no pain and 10 meaning the worst pain you can imagine | before and at 1 week, 1, 3, 6 months after stem cell injection | 
| Confirmation of the degree of improvement in disability (ODI) | on a scale of 0 to 3, with 0 meaning no disability and 10 meaning severe disability | before stem cell injection and at 1 week, 1, 3, and 6 months after injection | 
| Confirmation of increase in water content in the nucleus using MRI |  | before stem cell injection and at 1 and 6 month after injection |