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

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.


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