Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (GXCPC1) for Knee Osteoarthritis

NCT03943576 | Completed Phase 1

• 1 other identifier: GXCPC1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• WOMAC pain score

  Change from baseline in WOMAC pain score at Week 24

  week 24

Secondary Outcomes (3)

• MRI

  week 0, 24, 48

• Visual Analogue Scale (VAS)

  week 0, 1, 4, 12, 24

• 12-item Short Form (SF-12)

  week 0, 1, 4, 12, 24

Study Arms (2)

GXCPC1

EXPERIMENTAL

GXCPC1 contains 6.7×10\^6 or 4×10\^7 allogeneic adipose-derived stem cells (ADSCs) in 3 mL

Drug: GXCPC1

hyaluronic acid

ACTIVE COMPARATOR

Hya Joint Plus synovial fluid supplement 3mL

Device: HA

Interventions

GXCPC1 DRUG

The dose regimen is one single intra-articular injection of GXCPC1 containing 6.7×10\^6 or 4×10\^7 ADSCs in 3 mL saline. (allogeneic injection)

GXCPC1

HA DEVICE

Hya Joint Plus synovial fluid supplement 3mL

hyaluronic acid

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Participated other investigational study within 4 weeks prior to screening
• With ongoing or within the past 2 years serious medical conditions (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 (e.g. 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
• Female subject with childbearing potential who is lactating or has positive serum or urine pregnancy test at Screening
• Subject with childbearing potential refuses to use highly effective contraceptives from signing informed consent until Final/Early Termination Visit. At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms include:
• Established use of oral, injected or implanted hormonal methods of contraception

Sponsors & Collaborators

• Gwo Xi Stem Cell Applied Technology Co., Ltd.: lead

Study Sites (1)

GWOXI Stem Cell Applied Technology Co., Ltd.

Hsinchu, 30261, Taiwan

Location

Related Publications (1)

• Chen CF, Chen YC, Fu YS, Tsai SW, Wu PK, Chen CM, Chen WM, Wu HH, Lee CH, Chang CL, Lin PC, Kao YC, Chen CH, Chuang MH. Safety and Tolerability of Intra-Articular Injection of Adipose-Derived Mesenchymal Stem Cells GXCPC1 in 11 Subjects With Knee Osteoarthritis: A Nonrandomized Pilot Study Without a Control Arm. Cell Transplant. 2024 Jan-Dec;33:9636897231221882. doi: 10.1177/09636897231221882.

  PMID: 38205679 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Cheng-FONG Chen

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: May 9, 2019
• Study Start: December 1, 2019
• Primary Completion: April 27, 2022
• Study Completion: March 22, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

TW (1)