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
- Patients With Chronic Low Back Pain Due to Degenerative Lumbar Disc
- Registration Number
- NCT05011474
- Lead Sponsor
- Inbo Han
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 4
- 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
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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.
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patient with spinal instability, spondylitis, or vertebral fracture
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type 3 Modic change is in an endplate
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Patient whose disc height has decreased by more than 1/2 due to severe disc degenerative change
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Patient with severe osteoporosis (The average value of the T score in the lumbar spine bone density test is -2.5 or less)
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has undergone surgery, such as disc resection, on the disc to which the cells will be administered
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Patient who received lumbar epidural steroid injection 3 weeks before cell administration
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Pregnant or lactating women
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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
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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
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Patient with drug or alcohol addiction who cannot understand the purpose and method of this clinical trial
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Patient who participated in other clinical trials within 3 months prior to participation in the trial
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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)
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Patient with a history of malignant tumors within the last 5 years
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has a history of administration of cell therapy products
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 1) Adverse reaction and serious adverse reaction evaluation 2) laboratory inspection 3) Vital signs 4) Biochemical examination 5) Lumbar MRI 6) Monitoring systemic infection During Clinical Trial Period 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
- Secondary Outcome Measures
Name Time Method Confirmation of the degree of improvement in disability (ODI) before stem cell injection and at 1 week, 1, 3, and 6 months after injection on a scale of 0 to 3, with 0 meaning no disability and 10 meaning severe disability
Confirmation of increase in water content in the nucleus using MRI before stem cell injection and at 1 and 6 month after injection Confirmation of the degree of pain improvement in VAS before and at 1 week, 1, 3, 6 months after stem cell injection on a scale of 0 to 10, with 0 meaning no pain and 10 meaning the worst pain you can imagine
Trial Locations
- Locations (1)
CHA University, CHA Bundang Medical Center
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of