Clinical trial NCT05011474: 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
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Patients With Chronic Low Back Pain Due to Degenerative Lumbar Disc
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 4
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 1) Adverse reaction and serious adverse reaction evaluation 2) laboratory inspection 3) Vital signs 4) Biochemical examination 5) Lumbar MRI 6) Monitoring systemic infection
timeFrame: During Clinical Trial Period
Secondary outcomes:
measure: Confirmation of the degree of pain improvement in VAS
timeFrame: before and at 1 week, 1, 3, 6 months after stem cell injection
measure: Confirmation of the degree of improvement in disability (ODI)
timeFrame: before stem cell injection and at 1 week, 1, 3, and 6 months after injection
measure: Confirmation of increase in water content in the nucleus using MRI
timeFrame: before stem cell injection and at 1 and 6 month after injection
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA University, CHA Bundang Medical Center
state: Gyeonggi-do
Study officials:
References: