Safety and Efficacy Study of Matrilin-3 Pretreated Autolo... | NCT05011474

NCT05011474

Status Module

Name	Type	Description	Arm Group Labels	Other Names
administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3	Biological	Adipose-derived mesenchymal stem cells isolated from subject's adipose tissue are pretreated with matrillin 3 and produced in spheroid form.

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Eligibility Module

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