Efficacy and Safety of ELIXCYTE Intra-articular Injection in Subject With Knee Osteoarthritis

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase III, single-blinded (subject-blinded), placebo-controlled, multicenter study to investigate the efficacy and safety of a new study intervention, ELIXCYTE, compared to placebo (normal saline) in subjects with knee osteoarthritis. The primary hypothesis of the study is to demonstrate that ELIXCYTE is superior to placebo (saline) in improving knee pain on the target knee from baseline.

During the study, each participant will receive either ELIXCYTE (study intervention) or placebo (normal saline) intra-articular injection once on the target knee after eligibility criteria check. The target knee will be assessed by X-ray, MRI and subject self-evaluation knee questionnaires (WOMAC, KSS and KOOS) in the following visits. Other safety assessments, including lab test, physical examination, vital sign, medical/medication history and adverse events will also be collected throughout the study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UnicoCell Biomed CO. LTD

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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. Has participated in other investigational studies within 4 weeks prior to screening.

5. Administered monoamine oxidase inhibitor, selective serotonin reuptake inhibitor, serotonin-norepinephrine reuptake inhibitors, benzodiazepine, or tricyclic antidepressants within 4 weeks prior to screening.

6. With joint diseases expect knee OA that is considered not eligible to enter the study by the investigator.

7. Systemic diseases that may affect joints, including but not limited to inflammatory joint diseases, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

8. Known or suspected infection around the target knee joint.

9. 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.

10. With any evidence of malignant disease with a life expectancy less than 1 year.

11. With a known history of human immunodeficiency virus (HIV) infection.

12. With a known history of alcohol abuse.

13. With a known history of opioid dependent.

14. Known or suspected hypersensitivity to any ingredients of the investigational product (ELIXCYTE) or contrast medium for magnetic resonance imaging (MRI).

15. Body mass index (BMI) ≥ 35 kg/m2

16. Judged to be not applicable to this study by investigator such as the difficulty of follow-up observation.

17. Has claustrophobia and/or cannot take MRI test.

18. Has any existing active/inactive implanted medical devices, such as a cardiac pacemaker, cochlear, intracranial vascular clips, or neurostimulator, etc.

19. Has any existing metallic intraocular foreign body.

20. 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.

21. 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.

For exclusion criteria #20 and #21, 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).