Testing ELIXCYTE injection for knee osteoarthritis

A Phase III, Randomized, Parallel, Double-blinding, 2-Arm Study to Investigate the Efficacy and Safety of Intra-articular ELIXCYTE (Adipose-Derived Stem Cells) Injection Compared With Placebo in Subjects With Knee Osteoarthritis

This study is testing whether an injection called ELIXCYTE can help relieve pain for people aged 40 to 80 with knee osteoarthritis compared to a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: UnicoCell Biomed CO. LTD (Industry-sponsored)
• Locations: 4 sites (New Taipei City and 3 other locations)
• Trial ID: NCT05526001 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the efficacy and safety of ELIXCYTE, an intra-articular injection, compared to a placebo in patients with knee osteoarthritis. Participants aged 40 to 80 with unilateral or bilateral knee OA will receive either ELIXCYTE or saline injection, with assessments including X-rays, MRIs, and self-evaluation questionnaires. The study will involve approximately 165 subjects and will last about 50 weeks, including a screening period and multiple follow-up visits to monitor pain relief and safety outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 to 80 with moderate knee osteoarthritis who have not found relief from conventional therapies.

Not a fit: Patients who are suitable for knee surgery or have severe knee osteoarthritis symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce knee pain and improve mobility for patients suffering from knee osteoarthritis.

How similar studies have performed: Previous studies have shown promise with similar intra-articular injections for knee osteoarthritis, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

A subject is eligible for the study if all of the following apply:

1. Either gender, aged 40 to 80
2. With unilateral/bilateral knee OA of Kellgren-Lawrence grading II-III (determined by American College of Rheumatology criteria of knee OA).
3. WOMAC pain score of 7 - 17 in the target knee even if treated with chronic doses of NSAID.
4. 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.
5. Unwilling or not suitable to undergo knee surgery (including total knee replacement and knee arthroplasty).
6. Understands and has signed the informed consent form.
7. With adequate hematological indices:

   * White blood cell (WBC) ≥ 3,000/mm3
   * Platelet count ≥ 80,000/μL
8. With adequate coagulation indices: Prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of the normal range (ULN).
9. 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.
10. Has an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2, calculated by the Modification of Diet in Renal Disease (MDRD) equation.

Exclusion Criteria:

Any subject meeting any of the exclusion criteria will be excluded from study participation.

1. With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction, and knee arthroplasty on the target knee joint.
2. With any IA intervention of the target knee within 3 months prior to screening (e.g. steroid, anesthetic). But, sodium hyaluronate by IA intervention of the target knee within 6 months prior to screening.
3. Administered systemic anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drug or steroid) or topical anti-inflammatory drugs on the target knee within 7 days prior to screening. A subject requiring routine use of low-dose Aspirin for preventing thrombosis (≤ 100 mg/day) will not be excluded from this study.
4. Administered local immunosuppressive agent, local anti-inflammatory drug, local steroid, local analgesics, over-the-counter medications contain analgesics, herbal, homeopathic, or naturopathic remedies for knee OA within 2 weeks prior to screening.
5. Has participated in other investigational studies within 4 weeks prior to screening.
6. Administered monoamine oxidase inhibitor, selective serotonin reuptake inhibitor, serotonin-norepinephrine reuptake inhibitors, benzodiazepine, or tricyclic antidepressants within 4 weeks prior to screening.
7. With joint diseases expect knee OA that is considered not eligible to enter the study by the investigator.
8. Systemic diseases that may affect joints, including but not limited to inflammatory joint diseases, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
9. Known or suspected infection around the target knee joint.
10. Has serious medical conditions or ongoing disease (e.g. concomitant illness such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition, alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject.
11. With any evidence of malignant disease with a life expectancy less than 1 year.
12. With a known history of human immunodeficiency virus (HIV) infection.
13. With a known history of alcohol abuse.
14. With a known history of opioid dependent.
15. Known or suspected hypersensitivity to any ingredients of the investigational product (ELIXCYTE) or contrast medium for magnetic resonance imaging (MRI).
16. Body mass index (BMI) ≥ 35 kg/m2
17. Judged to be not applicable to this study by investigator such as the difficulty of follow-up observation.
18. Has claustrophobia and/or cannot take MRI test.
19. Has any existing active/inactive implanted medical devices, such as a cardiac pacemaker, cochlear, intracranial vascular clips, or neurostimulator, etc.
20. Has any existing metallic intraocular foreign body.
21. Female subject of childbearing potential who:

    * Is lactating; or
    * Has positive pregnancy test result at eligibility checking; or
    * Refuses to adopt at least one form of birth control from signing informed consent to the end of the study.
22. Male subject with female spouse/partner who is of childbearing potential refuses to adopt at least one form of birth control from signing informed consent to the end of the study.
23. Known allergy to acetaminophen and tramadol.
24. Has any abnormal radiographic evidence of target knee, such as excessive malalignment, other arthropathies, or systemic metabolic bone disease, etc.
25. Known any contraindication to IA intervention of the target knee, such as skin infection of injection site, coagulopathy, or routine use of anticoagulant, etc.

For exclusion criteria #21 and #22, acceptable forms of birth control include:

* Established use of oral, injected, or implanted hormonal methods of contraception.
* Placement of an intrauterine device (IUD) or intrauterine system (IUS).
* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps).

Where this trial is running

New Taipei City and 3 other locations

• Taipei Medical University Shuang-Ho Hospital — New Taipei City, Taiwan (Recruiting)
• Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
• Chang Gung Memorial Hospital, Linkou — Taoyuan, Taiwan (Recruiting)

Study contacts

• Study coordinator: Yu-Han Chang, MD

Conditions Knee Osteoarthritis