Status:
COMPLETED
Evaluate Safety and Explore Efficacy of SMUP-IA-01 in Patients With Knee Osteoarthritis
Lead Sponsor:
Medipost Co Ltd.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
This clinical trial is performed with patients with knee osteoarthritis who were radiologically diagnosed with Kellgren-Lawrence (K\&L) grade 2 or 3. Subjects who voluntarily signed consent form and m...
Detailed Description
All subjects in each dose-group will visit 1 month\* (visit 5, 1 month±5 days) after administration of investigational product to evaluate dose limit toxicity (DLT) and determine whether to drop or pr...
Eligibility Criteria
Inclusion
- Male and female over 19 years of age
- Subject with knee osteoarthritis (OA) and were diagnosed K\&L grade 2 or 3 in radioactive examination at time of screening
- Subject with more than 40mm joint pain on the 100-mm VAS, at the time of screening
- Subject who were diagnosed as knee osteoarthritis by American College of Rheumatology (ACR) guideline criteria, at the time of screening
- Subject with Body mass index (BMI) ≤35 kg/m2 at the time of screening
- 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
- Subject who agree to maintain contraception during study period
- Subject who voluntarily agreed to participate in the study, and signed informed consent
Exclusion
- Subject with myocardial infarction, congestive heart failure, and other severe heart disease or hypertension (or medical history of hypertension) that are not controlled below 140/90mmHg even with treatment with more than three(3) antihypertensive drugs
- Subject with serious medical conditions other than cardiovascular disease
- Subject with, or with a medical history of auto-immune diseases
- Subject with an infection that requires parenteral antibiotic administration.
- Subject with a medical history of mental disorder or epilepsy
- Subject with chronic inflammatory joint diseases such as rheumatoid arthritis (e.g., osteoarthritis with infectious joint disease, gouty arthritis, and osteoarthritis)
- 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
- Subject who are pregnant or lactating
- Subject abuse alcohol 10 times a week or smoke 25 cigarettes a day
- Subject who were diagnosed with cancer within 5 years before screening
- Subject who particiapted in another clinical trial within 4 weeks before screening of this clinical trial
- Subject who were administered with immunosuppressnats such as cyclosporin A or azathioprine within 6 weeks before screening
- Subject who had intra-articular administration such as sodium hyaluronate injections within 6 month before screening
- Subject who are suffering from skin disease or considered inappropriate for injection in the injection site
- Subject who has history of allergic response to hyaluronate injections or DMSO (cryopreservative) or Gentamicin (antibiotics)
- Subject who are consiered inappropriate for MRI assessment with Tesla higher than 3.0
- Subject with medical history of cell therapy product administration or are scheduled to administer other cell therapy product
- Subject who principal investigator (PI) considers inappropriate to participate in the study due to any reasons other than those listed above
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04037345
Start Date
October 7 2019
End Date
November 12 2020
Last Update
February 24 2021
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Jongno-gu, South Korea, 03080