Evaluate Safety and Explore Efficacy of SMUP-IA-01 in Patients With Knee Osteoarthritis
NCT ID: NCT04037345
Last Updated: 2021-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2019-10-07
2020-11-12
Brief Summary
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A total of 3 or 6 subjects will be enrolled in low-dose or mid-dose group each, and 6 subjects will be enrolled in high-dose group. The study used a dose escalation scheme (from low-dose to high-dose) to determine the maximum tolerated dose (MTD).
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Detailed Description
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Total 5 visit (1week, 1 month, 2 months, 3 months, 6 months) until 6 months after administration of investigational product is planned to assess safety through vial sign, laboratory tests, and exploratory efficacy of IP will be assessed through Western Ontario and McMaster Universities osteoarthritis index (WOMAC), 100-mm visual analogue scale (VAS) and International Knee Documentation Committee (IKDC) subjective knee evaluation.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SMUP-IA-01(low-dose)
A single knee administration of SMUP-IA-01 (low-dose, 4.0 x 10\^6 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)
SMUP-IA-01(low-dose)
A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10\^6 cells/2mL)
SMUP-IA-01(mid-dose)
A single knee administration of SMUP-IA-01 (mid-dose, 1.0 x 10\^7 cells/2mL) ( 2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)
SMUP-IA-01(mid-dose)
A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10\^7 cells/2mL)
SMUP-IA-01(high-dose)
A single knee administration of SMUP-IA-01 (high-dose, 2.0 x 10\^7 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)
SMUP-IA-01(high-dose)
A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10\^7 cells/2mL)
Interventions
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SMUP-IA-01(low-dose)
A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10\^6 cells/2mL)
SMUP-IA-01(mid-dose)
A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10\^7 cells/2mL)
SMUP-IA-01(high-dose)
A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10\^7 cells/2mL)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject with knee osteoarthritis (OA) and were diagnosed K\&L grade 2 or 3 in radioactive examination at time of screening
3. Subject with more than 40mm joint pain on the 100-mm VAS, at the time of screening
4. Subject who were diagnosed as knee osteoarthritis by American College of Rheumatology (ACR) guideline criteria, at the time of screening
5. Subject with Body mass index (BMI) ≤35 kg/m2 at the time of screening
6. Subject with ligament instability ≤Grade II (grade o: no ligament instability, grade I: 0 \~ 5㎜, grade Ⅱ: 5 \~ 10 ㎜, grade Ⅲ: \> 10 ㎜) at the time of screening
7. Subject who agree to maintain contraception during study period
8. Subject who voluntarily agreed to participate in the study, and signed informed consent
Exclusion Criteria
2. Subject with serious medical conditions other than cardiovascular disease
3. Subject with, or with a medical history of auto-immune diseases
4. Subject with an infection that requires parenteral antibiotic administration.
5. Subject with a medical history of mental disorder or epilepsy
6. Subject with chronic inflammatory joint diseases such as rheumatoid arthritis (e.g., osteoarthritis with infectious joint disease, gouty arthritis, and osteoarthritis)
7. Subject who had surgery or radiation therapy on knee joint area, or have not recovered from side effects of knee joint surgery within 12 weeks before screening
8. Subject who are pregnant or lactating
9. Subject abuse alcohol 10 times a week or smoke 25 cigarettes a day
10. Subject who were diagnosed with cancer within 5 years before screening
11. Subject who particiapted in another clinical trial within 4 weeks before screening of this clinical trial
12. Subject who were administered with immunosuppressnats such as cyclosporin A or azathioprine within 6 weeks before screening
13. Subject who had intra-articular administration such as sodium hyaluronate injections within 6 month before screening
14. Subject who are suffering from skin disease or considered inappropriate for injection in the injection site
15. Subject who has history of allergic response to hyaluronate injections or DMSO (cryopreservative) or Gentamicin (antibiotics)
16. Subject who are consiered inappropriate for MRI assessment with Tesla higher than 3.0
17. Subject with medical history of cell therapy product administration or are scheduled to administer other cell therapy product
18. Subject who principal investigator (PI) considers inappropriate to participate in the study due to any reasons other than those listed above
19 Years
ALL
No
Sponsors
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Medipost Co Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Myungchul Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Countries
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Other Identifiers
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MP-SMUP-IA-01-P01
Identifier Type: -
Identifier Source: org_study_id
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