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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
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Inclusion criteria
Exclusion criteria
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
Those diagnosed with Kellgren-Lawrence (K&L) grade 4 knee osteoarthritis (OA) at the time of screening
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
Patients with osteochondritis dissecans
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))
Those with the following confirmed medical history or surgical history / procedure history at the time of screening:
Those with any of the following diseases at the time of screening:
Those with any of the following drug administration/treatment history:
Those who fall under the following laboratory test results at the time of screening:
Patients with a malignant tumor (However, in the following cases, participation in the clinical trial may be allowed.)
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.
Those with a history of alcohol and drug abuse within one year prior to screening
For other reasons, those deemed inappropriate to participate in clinical trials according to the judgment of investigators
Primary purpose
Allocation
Interventional model
Masking
68 participants in 2 patient groups, including a placebo group
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Central trial contact
Insun Baek; Hyeseung Jeon
Data sourced from clinicaltrials.gov
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