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Trial record 53 of 120 for:    stem cell arthritis AND Phase

A Dose- Escalation Phase I Study to Evaluate Safety and Phase II Study to Evaluate Efficacy of GXCPC1 to Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03943576
Recruitment Status : Not yet recruiting
First Posted : May 9, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Gwo Xi Stem Cell Applied Technology Co., Ltd.

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 Intervention/treatment Phase
Knee Osteoarthritis Drug: GXCPC1 Device: HA Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Adipose-Derived Stem Cells (ADSCs) Injections for Knee Osteoarthritis
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: GXCPC1
GXCPC1 contains 6.7×106 or 4×107 allogeneic adipose-derived stem cells (ADSCs) in 3 mL
Drug: GXCPC1
The dose regimen is one single intra-articular injection of GXCPC1 containing 6.7×106 or 4×107 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




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, 36, 48 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943576


Contacts
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Contact: Chia-Hsin Lee +886 6585959 ext 341 jessie_lee@gwoxi.com

Sponsors and Collaborators
Gwo Xi Stem Cell Applied Technology Co., Ltd.
Investigators
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Principal Investigator: Cheng-FONG Chen Taipei Veterans General Hospital, Taiwan

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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: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases