| Eligibility |
Inclusion Criteria:
1. Male and females aged = 19 years and < 70 years
2. Have low back or hip pain that has lasted = 6 months at the time of screening and do
not respond to conservative therapy* given for = 3 months
* Conservative therapy: Rest at an early stage, drug treatment (e.g.,
anti-inflammatory drugs, analgesics, anesthetics, narcotic analgesics, muscle
relaxants), massage, acupuncture, chiropractic treatment, posture correction, home
lumbar exercise programs, etc.
3. The Oswestry Disability Index (ODI) of 30% or greater and below 90% at screening
4. The Visual Analogue Scale (VAS) score for pain in the lumbar spine of = 40 mm and = 90
mm in the last 3 months prior to screening
5. The magnetic resonance imaging (MRI) grade 3 to 6 between lumbar vertebra 1 and sacral
vertebra 1 according to the modified Pfirrmann classification method at screening
6. One pain-causing degenerative lumbar disc identified at screening. However,
degenerative lumbar discs causing pain are identified by discography.
7. Those who provide written consent to comply with the precautions after they or their
representatives voluntarily decide to participate subsequent to listening to a
detailed explanation of this clinical study and understanding it completely
Exclusion Criteria:
1. Body mass index (BMI) of 30 ?/m2 or greater
2. Those who require surgery because they have symptoms of nerve compression due to
severe lumbar spinal stenosis or lumbar herniated nucleus pulposus
3. Those with spinal instability, spondylitis, or vertebral fractures
4. Severe degenerative changes in the intervertebral disc leading to a 30% or more
decrease in the height of the intervertebral disc
5. Those who have modic type 3 changes on MRI
6. Those with severe osteoporosis
* An average T score of -2.5 or less in the lumbar bone density test (DEXA,
Dual-Energy X-ray Absorptiometry)
7. Those who have undergone procedures (electrocoagulation of the intervertebral disc,
etc.) and surgery such as discectomy on the disc to be administered with the
investigational product However, in the case of electrocoagulation, enrollment is
allowed if the procedure was performed 3 months prior to the administration of the
investigational product on the annulus fibrosus, not on the nucleus pulposus.
8. Those who took at least 75 mg/day of morphine equivalent dose (MED) during the
screening period
9. Those who have full-thickness annular tears (modified Dallas diagram scale grade 5) at
index level when a contrast medium is administered to annulus fibrosus (AF)
10. Those with clinically significant neuralgia (e.g., chronic radiculopathy) or
neuropathy
11. Those with clinically significant sacroiliac joint pain
12. Those who have compressive pathology due to stenosis or disc extrusion confirmed by
MRI, and have clinical symptoms of leg pain with VAS of 40 mm or more, or a
neurological deficit confirmed in a neurological examination
13. Those with intermittent neurogenic claudication due to central vertebral canal
stenosis
14. Those with lumbar spondylitis or ankylosing spondylitis caused by autoimmune diseases,
etc.
15. Those with facet joint pain confirmed through a diagnostic medical branch block
16. Those who have received an injection of a drug containing steroids into the disc,
except for the following drugs, within 3 weeks of the administration of the
investigational product (1) Contrast medium (discography or other diagnostic
injection) (2) Non-steroidal anti-inflammatory drugs (NSAIDs) (3) Nerve-blocking local
anesthetics: e.g., lidocaine, bupivacaine (4) Antibiotics (5) Normal saline (saline)
17. Those who have a history of malignancy within 5 years of screening
18. Those taking systemic immunosuppressants
19. Those who have received biological treatments such as proteins and antibody treatments
for the treatment of degenerative disc disease (DDD)
20. Those who have received intravertebral cell-therapeutic drugs or platelet rich plasma
(PRP) therapy (However, enrollment is allowed if stem cell therapy was administered by
a route other than the intervertebral disc and = 5 years have passed)
21. Those who may affect this clinical study due to serious medical disease [uncontrolled
hypertension, uncontrolled diabetes mellitus, uncontrolled active infection or
tuberculosis, cirrhosis of the liver, kidney failure, tumors, etc.]
22. Those with a history of allergy to protein products (bovine serum), antibiotics
(gentamicin), DMSO, and hyaluronic acid (HA) required for the manufacture of
cell-therapeutic drugs
23. Those who have a psychiatric history or are being treated, and the investigator
determines that it is difficult to proceed with the clinical study
24. Those who exceed 30 points on the Beck Depression Inventory (BDI)
25. Those who cannot understand the purpose, method, etc. of this clinical study due to
drug or alcohol addiction
26. Those who participated in other clinical studies within 6 months prior to
participation in this clinical study
27. Pregnant or breastfeeding women
28. Male or female patients of childbearing potential who do not agree to use medically
acceptable methods of contraception* during the clinical study period
* Medically acceptable methods of contraception: Condoms, oral contraceptives for at
least 3 months, injectable contraceptive procedure performed 3 months ago, use of
injectable or implantable contraceptives, intrauterine contraceptive devices, etc.
29. Those who are ineligible for participation in the clinical study in the judgment of
the principal investigator or sub-investigator due to other ethical reasons or reasons
that may affect the results of the clinical study
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