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

NCT05526001 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: CT22
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 4

Brief Summary

This is a Phase III, double-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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change of WOMAC pain score on the target knee

  WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a questionnaire to evaluate the condition of subjects with knee OA. The pain score ranges from 0 to 20.

  Baseline, Week 24

Secondary Outcomes (21)

• Percentage of pain responders (WOMAC pain score)

  Week 24 and Week 48

• Total scores of WOMAC

  Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48

• Pain subscale of WOMAC

  Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48

• Stiffness subscale of WOMAC

  Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48

• Functional subscale of WOMAC

  Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48

Study Arms (2)

ELIXCYTE

EXPERIMENTAL

Subjects will be intra-articular (IA) injected with 4 mL of ELIXCYTE (containing 32×10\^6 ADSCs) at the target knee once

Biological: ELIXCYTE

Placebo control (Saline)

PLACEBO COMPARATOR

Subjects will be intra-articular (IA) injected with 4 mL of saline at the target knee once

Drug: Saline

Interventions

ELIXCYTE BIOLOGICAL

ELIXCYTE, a new investigational product developed by UnicoCell Biomed, contains allogenic Adipose-derived stem cells (ADSCs). The ADSCs of ELIXCYTE for subjects were obtained from donors, and the Sponsor followed the manufacturing and testing procedures described in chemistry, manufacturing and control (CMC) information in order to assure the quality of final products.

ELIXCYTE

Saline DRUG

Placebo control used in the study.

Placebo control (Saline)

Eligibility Criteria

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

You may qualify if:

• A subject is eligible for the study if all of the following apply:
• Either gender, aged 40 to 80
• With unilateral/bilateral knee OA of Kellgren-Lawrence grading II-III (determined by American College of Rheumatology criteria of knee OA).
• WOMAC pain score of 7 - 17 in the target knee even if treated with chronic doses of NSAID.
• Has received 1 - 3 types of pharmacological therapies for knee OA for more than 3 months but the symptoms have not relieved.
• Unwilling or not suitable to undergo knee surgery (including total knee replacement and knee arthroplasty).
• Understands and has signed the informed consent form.
• With adequate hematological indices:
• White blood cell (WBC) ≥ 3,000/mm3
• Platelet count ≥ 80,000/μL
• 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).
• 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.

You may not qualify if:

• With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction (with the exception of meniscal debridement), and knee arthroplasty on the target knee joint.
• With any IA intervention of the target knee within 3 months prior to screening (e.g. steroid, anesthetic), or sodium hyaluronate by IA intervention of the target knee within 6 months prior to screening.
• Administered systemic immunosuppressive agent, systemic antiinflammatory drug, systemic steroid, systemic analgesics (except acetaminophen, and tramadol as rescue medications), duloxetine, or over-the-counter medications contain analgesics (e.g. cold medicine) within 2 weeks prior to screening. Administered systemic herbal, homeopathic, or naturopathic remedies for knee OA within 2 weeks 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
• 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.
• Has participated in other investigational studies within 4 weeks prior to screening.
• Administered monoamine oxidase inhibitor, selective serotonin reuptake inhibitor, serotonin-norepinephrine reuptake inhibitors, benzodiazepine, or tricyclic antidepressants within 4 weeks prior to screening.
• With joint diseases expect knee OA that is considered not eligible to enter the study by the investigator.
• Systemic diseases that may affect joints, including but not limited to inflammatory joint diseases, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and fibromyalgia.
• Known or suspected infection around the target knee joint.
• 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.
• With any evidence of malignant disease with a life expectancy less than 1 year.
• With a known history of human immunodeficiency virus (HIV) infection.
• With a known history of alcohol abuse.
• With a known history of opioid dependent.
• Known or suspected hypersensitivity to any ingredients of the investigational product (ELIXCYTE) or contrast medium for magnetic resonance imaging (MRI).

Sponsors & Collaborators

• UnicoCell Biomed CO. LTD: lead

Study Sites (4)

Taipei Medical University Shuang-Ho Hospital

New Taipei City, Taiwan, 23561, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: September 2, 2022
• Study Start: July 3, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

TW (4)