| Eligibility |
Inclusion Criteria:
1. Adult men and women over 19 years of age
2. Those with a body mass index (BMI) of less than 30 kg/m2 at screening
3. Those classified as ICRS grade 3 or 4 according to the International Cartilage Repair
Society (ICRS) rating system through MRI examination at the time of screening
4. Those diagnosed with knee osteoarthritis according to the diagnosis criteria of the
American College of Rheumatology (ACR) at the time of screening
5. Those diagnosed with Kellgren-Lawrence (K&L) grade 2-3 knee osteoarthritis (OA) at the
time of screening
6. Those who do not have clinically significant abnormalities in the results of physical
examination, hematologic test, blood chemistry test, or urine test
7. Those whose symptoms (pain, etc.) do not improve despite conservative therapy (drug
therapy, physical therapy, etc.) for at least 12 weeks
8. Those with a 100 mm Visual Analogue Scale (VAS) score* for pain at the time of
screening of 50 mm or more
9. Those who have heard and fully understood the detailed description of this clinical
trial and have voluntarily decided to participate and agreed in writing to comply with
the precautions
Exclusion Criteria:
1. Those who have participated in at least one other clinical trial within 4 weeks before
screening and received drugs (based on the last administration date), or received
medical device treatment for clinical trials
2. Those diagnosed with Kellgren-Lawrence (K&L) grade 4 knee osteoarthritis (OA) at the
time of screening
3. At the time of screening, those with the results of the physical examination showing
grade III (grade 0: none, grade I: 0~5 mm, grade II: 5~10 mm, grade III: >10 mm) or
more ligament instability
4. Patients with osteochondritis dissecans
5. Those with hypersensitivity reactions or allergies to components of the
investigational product, FURESTEM-OA Kit Inj. (combination of (FURESTEM-OA
Inj.)(solution 1) + (CAM Inj.)(solution 2))
6. Those with the following confirmed medical history or surgical history / procedure
history at the time of screening:
- Patients with a history of procedure or surgery (including arthroscopy) on the
target knee within 24 weeks prior to the baseline visit (Visit 2)
- Patients who have undergone a knee joint replacement
7. Those with any of the following diseases at the time of screening:
- Those with active infectious disease (hepatitis A/B/C (including carriers) or HIV
infection that in the opinion of the investigator render those subjects as unfit
to participate in this clinical trial. However, those who test positive by
vaccination may participate.)
- Those who have been determined by the investigator as having difficulty
participating in this clinical trial due to a severe chronic disease
(cardiovascular disease, metabolic disease, renal dysfunction, etc., excluding
controlled hypertension)
- Those with a skin disease or infection on the skin surface at the site where the
investigational product is to be administered
- Those with severe pain in other areas that may affect the determination of
symptoms in the knee joint (e.g., patients with poly-articular joint pain with
severe osteoarthritis symptoms in other areas (such as the hip joint))
- Patients with other joint diseases, such as inflammatory joint diseases including
rheumatoid arthritis, or infectious joint diseases such as septic arthritis,
gout, recurrent pseudogout, joint fracture, acromegaly, Wilson's disease, primary
osteochondrosis
- Patients with secondary osteoarthritis due to systemic diseases such as
ochronosis or hemochromatosis
- Patients with genetic diseases such as hyperkinesia or collagen gene
abnormalities
- Patients with severe painful conditions such as Sudeck's atrophy, Paget's
disease, or spinal disc herniation
8. Those with any of the following drug administration/treatment history:
- If herbal drugs (for osteoarthritis treatment), glucosamine, chondroitin,
anti-inflammatory drugs, patches, and/or other external preparations were
administered within 14 days prior to the baseline visit (Visit 2) (However,
participation in the clinical trial may be allowed after a sufficient wash-out
period, and for glucosamine and chondroitin, participation in clinical trials is
possible for health functional foods only if continuously administered from 4
weeks before screening)
- Those who have been given drugs through intra-articular injection A. Patients who
received hyaluronic acid (HA) in the target joint cavity within 12 weeks of
screening B. Patients who received steroids in the target joint cavity within 12
weeks of screening C. Patients who systemically used steroids within 4 weeks of
screening (except for topical application and inhalation)
- Those who have performed physical therapy or oriental medical treatment
(acupuncture, swelling, moxibustion, etc.) by a specialist for the purpose of
relieving pain within 14 days prior to the baseline visit (Visit 2)
- Those who have been given an analgesic within 14 days before administration of
the investigational product, or within a time period 5 times the half-life of the
analgesic.
- Those who have been given an immunosuppressive drug (cyclosporin A or
azathioprine) including antirheumatic drug (including methotrexate or
antimetabolite) within 12 weeks prior to the baseline visit (Visit 2)
- Those who have been given an anesthetic within 2 days prior to the baseline visit
(Visit 2)
- Those who have had gene therapy or cytotherapy for treatment of the knee joint
9. Those who fall under the following laboratory test results at the time of screening:
- Serum creatinine > 2.0 mg/dL renal dysfunction
- AST or ALT test result is more than 2.5 times the upper limit of the normal range
10. Patients with a malignant tumor (However, in the following cases, participation in the
clinical trial may be allowed.)
- Those who have been diagnosed with complete remission at least 5 years after
completion of treatment for the tumor
- If at least 1 year has elapsed since complete resection of a basal cell
carcinoma/squamous cell carcinoma, radical resection of papillary thyroid cancer,
or successful treatment of cervical epithelial cancer
11. Women and men of childbearing potential who are pregnant, nursing, or do not agree to
perform appropriate contraception
*Hormonal contraception (cutaneous patch, injection, oral contraceptive, etc.),
intrauterine devices (loop, intrauterine system containing hormone), sterilization
procedure for oneself or spouse (or partner) (vasectomy, tubal ligation, etc.), double
blocking (both male (condom) and female (contraceptive diaphragm, vaginal sponge or
cervical cap) must use a contraceptive device), etc.
12. Those with a history of alcohol and drug abuse within one year prior to screening
13. For other reasons, those deemed inappropriate to participate in clinical trials
according to the judgment of investigators
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