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Chondrochymal® for Subjects With Knee Osteoarthritis (Knee OA)

NCT05027581 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-07-04

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee

Interventions

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 \[HA\])

Sponsors & Collaborators

  • A2 Healthcare Taiwan Corporation

    collaborator INDUSTRY

  • Taiwan Bio Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-13
Primary Completion
2023-12-10
Completion
2025-06-04

Countries

  • Taiwan

Study Locations

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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 NCT05027581 on ClinicalTrials.gov