Adipose-Derived Stem Cells (ADSCs) Injections for Knee Osteoarthritis

Gwo Xi Stem Cell Applied Technology Co., Ltd.1 site in 1 country25 target enrollmentDecember 1, 2019

InterventionsGXCPC1 HA

Overview

The aim of the investigators study was to investigate the safety and efficacy of allogeneic ADSCs for the clinical treatment of knee osteoarthritis.

Registry

clinicaltrials.gov

Start Date

December 1, 2019

End Date

March 22, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Provision of signed and dated informed consent form
•Aged 40 to 80 years old (inclusive)
•Kellgren-Lawrence grading II-IV, as determined by American College ofRheumatology (ACR) criteria for osteoarthritis of the knee
•Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score of 7 \~ 17 (inclusive) in the target knee despite use of NSAID
•Contraindicated to long term systemic NSAID (e.g. suffer from severe gastrointestinal side effects upon systemic NSAID administration, or due to underlying increased gastrointestinal, cardiovascular, or renal risk) and not able to receive or wish to delay knee arthroplasty

•With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction, and knee arthroplasty on the target knee joint
•With previous intra-articular intervention (e.g. steroid, anesthetics, hyaluronate, arthroscopic surgery) on the target knee joint 12 weeks prior to screening
•Administered or required systemic or local on the target knee joint immunosuppressive agent, anti-inflammatory drug, steroid, analgesics, opioid, or duloxetine for OA knee except for acetaminophen and NSAID within 1 week prior to screening
•With joint diseases other than knee osteoarthritis considered by investigator not eligible to enter the study
•Unable to receive MRI examination, including allergic to the contrast medium for MRI used in the study, with known history of claustrophobia, having any existing metallic intraocular foreign body or active/inactive implanted medical devices, such as cardiac pacemaker, cochlear, intracranial vascular clips or neurostimulator
•Active or suspected infection of the target knee joint
•History of human immunodeficiency virus (HIV) infection
•History of malignancy within 2 years prior to screening
•With body mass index (BMI) greater or equal to 35 kg/m2
•Known hypersensitivity to any component of the investigational product or the active control