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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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

  • Clinicaltrials.gov identifier

    NCT03943576

  • Recruitment Status

    Recruiting

  • First Posted

    May 9, 2019

  • Last update posted

    March 17, 2020

Study Description

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.

  • Condition or Disease:Knee Osteoarthritis
  • Intervention/Treatment: Drug: GXCPC1
    Device: HA
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Official Title: Adipose-Derived Stem Cells (ADSCs) Injections for Knee Osteoarthritis
  • Actual Study Start Date: December 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: October 2022

Arms and interventions

Arm Intervention/treatment
Experimental: GXCPC1
GXCPC1 contains 6.7×10^6 or 4×10^7 allogeneic adipose-derived stem cells (ADSCs) in 3 mL
Drug: GXCPC1
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)
Active Comparator: hyaluronic acid
Hya Joint Plus synovial fluid supplement 3mL
Device: HA
Hya Joint Plus synovial fluid supplement 3mL

Outcome Measures

  • Primary Outcome Measures: 1. WOMAC pain score [ Time Frame: week 24 ]
    Change from baseline in WOMAC pain score at Week 24
  • Secondary Outcome Measures: 1. MRI [ Time Frame: week 0, 24, 48 ]
    Change from baseline to post-treatment visits on the target knee in MRI examination results
  • 2. Visual Analogue Scale (VAS) [ Time Frame: week 0, 1, 4, 12, 24 ]
    Changes from baseline to post-treatment visits on the target knee in Visual Analogue Scale (VAS) for pain
  • 3. 12-item Short Form (SF-12) [ Time Frame: week 0, 1, 4, 12, 24 ]
    Change from baseline to post-treatment visits in total score of 12-item Short Form (SF-12) health survey questionnaire

Eligibility Criteria

  • Ages Eligible for Study: 40 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Aged 40 to 80 years old (inclusive)

3. Kellgren-Lawrence grading II-IV, as determined by American College ofRheumatology
(ACR) criteria for osteoarthritis of the knee

4. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score of 7
~ 17 (inclusive) in the target knee despite use of NSAID

5. 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

Exclusion Criteria:

1. With previous surgery of articular fracture, ligament reconstruction, meniscal
reconstruction, and knee arthroplasty on the target knee joint

2. With previous intra-articular intervention (e.g. steroid, anesthetics, hyaluronate,
arthroscopic surgery) on the target knee joint 12 weeks prior to screening

3. 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

4. With joint diseases other than knee osteoarthritis considered by investigator not
eligible to enter the study

5. 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

6. Active or suspected infection of the target knee joint

7. History of human immunodeficiency virus (HIV) infection

8. History of malignancy within 2 years prior to screening

9. With body mass index (BMI) greater or equal to 35 kg/m2

10. Known hypersensitivity to any component of the investigational product or the active
control

11. Participated other investigational study within 4 weeks prior to screening

12. 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

13. Female subject with childbearing potential who is lactating or has positive serum or
urine pregnancy test at Screening

14. 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

- Placement of an intrauterine device (IUD) or intrauterine system (IUS)

- Barrier methods of contraception: condom, or occlusive cap (diaphragmor
cervical/vault caps)

Contacts and Locations

Contacts

Contact: Chia-Hsin Lee +886 6585959 ext 341 jessie.lee@gwoxi.com

Locations

Taiwan
GWOXI Stem Cell Applied Technology Co., Ltd.
Hsinchu

Sponsors and Collaborators

Gwo Xi Stem Cell Applied Technology Co., Ltd.

Investigators

Principal Investigator: Cheng-FONG Chen Taipei Veterans General Hospital, Taiwan

More Information

  • Responsible Party: Gwo Xi Stem Cell Applied Technology Co., Ltd.
  • ClinicalTrials.gov Identifier: NCT03943576 History of Changes
  • Other Study ID Numbers: GXCPC1
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: March 17, 2020
  • Last Verified: March 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Osteoarthritis, Knee Osteoarthritis