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

NCT05526001 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2025-11-21

No results posted yet for this study

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

Interventions

BIOLOGICAL

ELIXCYTE

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.

DRUG

Saline

Placebo control used in the study.

Sponsors & Collaborators

  • UnicoCell Biomed CO. LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-03
Primary Completion
2026-05-31
Completion
2026-11-30
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05526001 on ClinicalTrials.gov