Patients With Chronic Low Back Pain Due to Degenerative Lumbar Disc
Conditions
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.
Interventions
BIOLOGICALadministered 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.
Sponsors
Inbo Han
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
Countries
South Korea
Outcome results
None listed