NCT05027581

Chondrochymal® for Subjects With Knee Osteoarthritis (Knee OA)

A Phase IIb Study to Evaluate the Efficacy and Safety of Chondrochymal® for Subjects With Knee Osteoarthritis (Knee OA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Taiwan Bio Therapeutics Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Bone marrow mesenchymal stem cells	The bone marrow mesenchymal stem cells (BM-MSCs) in Chondrochymal® for this study was obtained from the donor recruited in Taipei Veterans General Hospital, Taiwan. Donors aged 20 to 50 and tested negative to infection of human immunodeficiency virus type 1 and 2 (HIV-1/2), hepatitis B virus (HBV), hepatitis C virus (HCV), Cytomegalovirus (CMV), Treponema pallidum (syphilis), human T-lymphotropic virus types I and II (HTLV-I/II), and Tuberculosis (TB) were enrolled. The eligible donor's bone marrow was aspirated from the iliac crest or femur. The collected BM-MSCs were then cultured, expanded and cryopreserved in a Good Tissue Practice (GTP)-complied laboratory. The qualified cells in cryopreservation meeting the release criteria will be thawed, mixed with lactated Ringer's solution, and transferred into a sterile syringe as the final product.
DRUG	hyaluronic acid	(60 mg/3 mL hyaluronic acid \[HA\])

Timeline

• Start date: 2021-10-13
• Primary completion: 2023-12-10
• Completion: 2025-06-04
• First posted: 2021-08-30
• Last updated: 2025-07-04

Locations

2 sites across 1 country: Taiwan