Chondrochymal® for Subjects With Knee Osteoarthritis (Knee OA)

Status Active, not recruiting

Clinical Trial Summary

This is a randomized, single-blind, parallel, active-controlled study to evaluate the efficacy and safety of bone marrow mesenchymal stem cells (BM-MSCs), Chondrochymal®, in subjects aged 40 to 80 with knee OA.

Clinical Trial Description

This phase IIb study is a prospective, single-blind, parallel, active-controlled study to evaluate the efficacy and safety of Chondrochymal® in subjects with knee OA. All the subjects will be enrolled in Taiwan. The target population is composed of subjects with unilateral or bilateral OA knee(s). For subjects with bilateral OA knees, only the knee with more severe symptoms will be selected as the target knee. If the severities of the OA symptoms are the same for both knees, the knee with more pain should be selected, where the WOMAC pain score will take the priority over the VAS index. Eligible subjects will be randomized into one of the study groups, Chondrochymal® Group or Control Group, in 1:1 ratio. To keep the blindness, the subject's eyesight will be masked by a curtain while receiving the IA injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05027581
Study type	Interventional
Source	Taiwan Bio Therapeutics Co., Ltd.
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	September 15, 2021
Completion date	March 10, 2025

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