Chondrochymal® for Subjects With Knee Osteoarthritis (Knee OA) (NCT05027581) | Clinical Trial Compass
CompletedPhase 2
Chondrochymal® for Subjects With Knee Osteoarthritis (Knee OA)
Taiwan72 participantsStarted 2021-10-13
Plain-language 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.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. With congenital or acquired bone hypoplasia (Varus more than 10° or Valgus more than 20°).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested something called Chondrochymal® for knee osteoarthritis — can you explain what Chondrochymal® actually is and how it's different from treatments I might already be considering?
2Since this was a Phase 2 trial that has now completed, what do the WOMAC results actually tell us about how much pain and function might realistically improve, and are those results published yet so we can look at them together?
3Because this is only Phase 2, the safety profile is still being established — are there any side effects or risks from this treatment that I should be especially aware of given my specific health history?
4Now that this trial is completed and I can't enroll, are there any follow-up Phase 3 trials or similar studies using Chondrochymal® that I might be eligible for, or would standard treatments be a better path for me right now?
5How does the improvement measured by the WOMAC score in this trial compare to what I might expect from standard knee osteoarthritis treatments like physical therapy, injections, or surgery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessment
. 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.