Evaluation of safety and efficacy of allogeneic placenta-derived mesenchymal stem cell therapy (PLARTISTEM®) in patients with osteoarthritis
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0005269
- Lead Sponsor
- Medicrinia Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
1. Subjects who diagnosed as osteoarthritis based on ACR criteria
2. Subjects who are scheduled to undergo microfracture treatment for cartialge defect due to osteoarthritis
3. Kellegren & Lawrence Grade 2-3
4. Arthrscopy confirmed ICRS grade 3 or 4 cartilage lesion
5. No improvement of symptoms by nonoperative treatment for at least 3 months
6. Pain on the target knee > 40 mm on VAS at screening
7. Adults of age 20 or older
8. Major cartilage defect size 2 ? ~ 9 ? at one compartment showing most prominent symptoms
9. More painful knees in case of bilateral knee pain
10. BMI between 18-35
11. No clinically significant abnormal findings in physical exam, blood lab tests, and urine lab tests
12. Female subjects who consented to contraception during the Part I study period
13. Subjects who are willing to participate in this study and signed the informed consent form
1. BMI =35?/? at screening visit
2. Taking psychotropic substance or opioid pain killer for the recent 3 months
3. Clinical significant abnormal lab test results at screening
4. Rheumatoid arthritis or other inflammatory or metabolic arthritis
5. Any signs of infection at the target knee or around the joint
6. Secondary arthrtiis due to Ochronosis, Hemochromatosis, or other systemic disease
7. Subjects with significant pain such as Sudeck’s atrophy, Paget’s disease, fibromyalgia, or CRPS
8. Signifcant deformity of the knee due to osteoarthhritis (HKA angle deviation > 10 degree)
9. Subjects with significant pain at other joints(hip, spine, etc) that may affect knee pain
10. Subjects with significant pain at the other knee that the investigator considers inappropriate to be enrolled in this study
11. Administraion of the below found at screeing visit
1) Hyaluronic acid injection at the target knee or other joint within 6 month
2) Steroid injection at the target knee within 3 months
3) Systemic administration of steroid within 1 month (except inhalant)
12. History of arthroscopic or open surgery at the target knee within 1 year (except arthroscopic examination only)
13. History of replacement surgery at the target knee
14. Subjects who have to use anticoagulant (except low dose aspiring, daily dose less than 300 mg)
15. Grade II or more ligament laxity at the target knee
16. History of allergy to Hyaluronate or Gentamicin
17. Subjects who need to take immunosuppressant or who took immunosuppressant such as Cyclosprin A or Azathioprine within 6 weeks
18. Subjects who had taken other cell therapy product
19. Female subjects who do not agree contraception during the part I trial period
20. Subjects who are pregnant or on breast feeding
21. Subjects participating in another clinical trial in during the trial period
22. Subjects deemed inappropriate by the investigator other than the above items
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse reactions;Symptom improvement assessed by KOOS at 48 weeks compared to baseline
- Secondary Outcome Measures
Name Time Method Assessment of cartilage repair at the defect site;Dose limiting toxicity