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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05944627 on ClinicalTrials.gov