Evaluate Safety and Explore Efficacy of FURESTEM-OA Kit Inj. in Patients With Knee Osteoarthritis
NCT05944627 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2023-07-14
Summary
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
Conditions
Interventions
- 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.
- BIOLOGICAL
-
placebo administration in Phase 2a clinical trial
Sponsors & Collaborators
-
Kang Stem Biotech Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Kyoung-Ho Yoon, professor (CI) · Kyung Hee University Hospital
-
Sang Hak Lee, professor · Gangdong Kyunghee University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-06
- Primary Completion
- 2024-03-31
- Completion
- 2026-02-28
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