Chondrochymal® for Subjects With Knee Osteoarthritis (Knee OA)

NCT05027581 | Completed Phase 2

• 1 other identifier: Chondrochymal-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

knee osteoarthritis; BM-MSC

Outcome Measures

Primary Outcomes (1)

• Efficacy-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessment

  Change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score on the target knee at Week 24. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC LK 3.1) is applied extensively to patients with osteoarthritis of the hip or knee. It is a 24-item patient-reported questionnaire with a total score ranging from 0 to 96. The sub-scores range from 0 to 4 for each item with a higher score indicating a more severe OA symptom. The WOMAC includes 3 domains: (1) Pain: 5 items (score range: 0 to 20), (2) Stiffness: 2 items (score range: 0 to 8), and (3) Functional limitation: 17 items (score range: 0 to 68). For ease of interpretation, WOMAC scores (including total scores and sub-scores) will be linearly transformed to a 0 to 100 scale.

  Week 24

Secondary Outcomes (11)

• Efficacy-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessment

  Week 4、Week 12、Week 24、Week 36、Week 52

• Efficacy-Visual Analogue Scale (VAS) assessment

  Week 4、Week 12、Week 24、Week 36、Week 52

• Efficacy-SF-36 Quality of Life (QoL) health survey questionnaire

  Week 4、Week 12、Week 24、Week 36、Week 52

• Efficacy-Whole-Organ Magnetic Resonance Imaging Score (WORMS)

  Week 24、Week 52、Week 104

• Efficacy-knee joint space width (JSW)

  Week 24、Week 52

Study Arms (2)

Chondrochymal® group

EXPERIMENTAL

Subjects will be IA injected at the target knee with 3 mL of Chondrochymal® containing 5.0 x 107 BM-MSCs in lactated Ringer's solution at Day 1.

Drug: Bone marrow mesenchymal stem cells

Hya-Joint Plus Synovial Fluid Supplement

ACTIVE COMPARATOR

Hya-Joint Plus Synovial Fluid Supplement containing 60 mg/3 mL of hyaluronic acid will be IA administrated into the subject's target knee at Day 1.

Drug: hyaluronic acid

Interventions

Bone marrow mesenchymal stem cells DRUG

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.

Also known as: Chondrochymal®

Chondrochymal® group

hyaluronic acid DRUG

(60 mg/3 mL hyaluronic acid \[HA\])

Also known as: Hya-Joint Plus Synovial Fluid Supplement

Hya-Joint Plus Synovial Fluid Supplement

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All genders aged 40 to 80 (inclusive).
• WOMAC pain score equals to or higher than 7 in the target knee.
• Subject with unilateral/bilateral OA knee(s) of Kellgren-Lawrence grading II-IV, who is not suitable for or unwilling to undergo knee surgery (including total knee replacement).
• Pain of the target knee as assessed by Visual Analogue Scale (VAS) equals to or higher than 4.
• Body mass index (BMI) between 20 and 35 kg/m2.
• Has received conventional therapies for knee OA (e.g., analgesic administration or physical therapy) for more than 3 months but the symptoms have not relieved.
• With adequate hematological indices: - White blood cell (WBC) ≥ 3,000/mm3 - Platelet count ≥ 80,000/μL - Prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of the normal range (ULN)
• With adequate liver function where serum total bilirubin ≤ 1.5 times ULN, aspartate aminotransferase (AST) ≤ 3 times ULN, and alanine aminotransferase (ALT) ≤ 3 times ULN.
• Has an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2, calculated by the Modification of Diet in Renal Disease (MDRD) equation.
• Understand and sign the informed consent form.

You may not qualify if:

• With congenital or acquired bone hypoplasia (Varus more than 10° or Valgus more than 20°).
• Had any intra-articular (IA) injection or surgery of the target knee within 3 months prior to screening, or had received any prior cell therapy on the target knee.
• With severe knee osteoarthritis on the target knee who has decided to receive surgery (including total knee replacement) per surgeon's advice before screening.
• With coagulation or hematological disorder not suitable for IA injection.
• Administered or requiring systemic or topical on the target knee joint immunosuppressive agent, anti-inflammatory drug, steroid, analgesics, opioid, or duloxetine for knee OA, except for acetaminophen (oral daily dose ≤ 2000 mg or topical use at any dose level), Etoricoxib (oral daily dose ≤ 120 mg or topical use at any dose level), and Celebrex (oral daily dose ≤ 200 mg or topical use at any dose level), within 1 week prior to screening. For long-acting steroids (e.g., dexamethasone), a subject received systemic treatment within 2 weeks before screening will be excluded. A subject requiring routine use of low-dose Aspirin for preventing thrombosis (≤ 100 mg/day) will not be excluded from this study.
• With spontaneous knee osteonecrosis on either knee.
• With crippled lower limb(s) rated ACR functional class IV (Largely or Wholly Incapacitated) or cannot walk without one/two arm(s)-operated walking assisting device (defined by CNS15390).
• With effusion, bleeding, ligament instability, arthrochalasis, muscular or neurological diseases causing deformity of the knee joint, or any joint diseases other than OA on the target knee.
• Active systemic infection or acute infection around the target knee joint.
• Any significant dermatological disease near the injection site that is not suitable for IA injection at the investigator's discretion.
• Has claustrophobia and/or cannot take magnetic resonance imaging (MRI) test.
• Any metal devices placed in the body such as pacemaker, artificial heart valve, or hemostatic clamps/clips for intracranial aneurysm posing risk under magnetic field (of MRI).
• Previous surgery of the target knee that may cause metal imaging artifacts on imaging study.
• Known or possible allergy to components of the study drugs or rescue medications.
• Any form of primary immunodeficiency or autoimmune disease requiring systemic immunosuppressive therapy.

Sponsors & Collaborators

• Taiwan Bio Therapeutics Inc.: lead
• A2 Healthcare Taiwan Corporation: collaborator

Study Sites (2)

Taipei Veterans General Hospital

Taipei, Beitou District, 112, Taiwan

Location

Taipei Municipal Wangfang Hospital (Managed by Taipei Medical University)

Taipei, Wenshan District, 116, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 30, 2021
• Study Start: October 13, 2021
• Primary Completion: December 10, 2023
• Study Completion: June 4, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)