Evaluate Safety and Explore Efficacy of FURESTEM-OA Kit Inj. in Patients With Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT05944627|
Recruitment Status : Not yet recruiting
First Posted : July 13, 2023
Last Update Posted : July 14, 2023
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Biological: FURESTEM-OA Kit Inj. Biological: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Phase 1 clinical trial was an open-label. Phase 2a clinical trial was conducted in a single-blind.|
|Official Title:||A Single, Dose Escalation, Optimal Dose Finding Phase I/IIa Clinical Trial to Evaluate Safety and Explore Efficacy of the Single Treatment of FURESTEM-OA Kit Inj. in Patients With Knee Osteoarthritis|
|Estimated Study Start Date :||July 6, 2023|
|Estimated Primary Completion Date :||March 31, 2024|
|Estimated Study Completion Date :||February 28, 2026|
Experimental: FURESTEM-OA Kit Inj.
Subjects are slowly administered FURESTEM-OA Kit Inj. once into the knee joint cavity contained in a disposable sterile syringe mixed with Solution 1 and Solution 2 depending on the dose group assigned at the baseline (Visit 2).
The subjects are assigned sequentially to the following 3 dose groups in Phase 1 clinical trial, and in Phase 2a clinical trial, the subjects are randomized to 1-2 dose groups below MTD determined in Phase 1.
Biological: FURESTEM-OA Kit Inj.
FURESTEM-OA Kit Inj. is a combination medical product in which FURESTEM-OA Inj. (solution 1) is the primary mode of action and CAM Inj. (solution 2) acts as an auxiliary. The product is administered after mixing solution 1 and solution 2.
Placebo Comparator: Placebo
Product name: Placebo of FURESTEM-OA Kit Inj. (placebo administration in Phase 2a clinical trial)
placebo administration in Phase 2a clinical trial
- Assessment of safety and tolerability of FURESTEM-OA Kit Inj. [ Time Frame: 4 weeks follow-up after treatment ]Maximum Tolerated Dose (MTD) identification based on Dose Limiting Toxicities (DLTs) evaluation Evaluation of adverse events
- Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS) score [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment ]
- Rate and amount of changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment ]
- Changes in 100 mm VAS score [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment ]
- Changes in the International Knee Documentation Committee Scoring System (IKDC) score [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment ]
- Evaluation of K&L grade [ Time Frame: week 24 after treatment ]
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score [ Time Frame: week 24 after treatment ]
- Whole-Organ Magnetic Resonance Imaging Score (WORMS) score [ Time Frame: week 24 after treatment ]
- Rate and amount of changes in biomarker values [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05944627
|Contact: Insun Baekfirstname.lastname@example.org|
|Contact: Hyeseung Jeonemail@example.com|
|Principal Investigator:||Kyoung-Ho Yoon, professor (CI)||Kyung Hee University Hospital|
|Principal Investigator:||Sang Hak Lee, professor||Gangdong Kyunghee University Hospital|