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Completed

NCT Number: NCT02784964

Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis

1. To assess the safety of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis 2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis

Completed

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Taipei Veterans General Hospital, Taipei, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 40-80 years (inclusive)
  • Kellgren-Lawrence grading I-III, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score of 7-17 in the study knee even if treated with chronic doses of non steroidal anti-inflammatory drugs
  • Having provided informed consent

Exclusion criteria

  • With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction, and knee arthroplasty on the target knee joint
  • With previous intra-articular intervention on the target knee joint within past 3 months (e.g. steroid, anaesthetic, sodium hyaluronate)
  • Known or suspected infection of the target knee joint
  • Ascertained hypersensitivity to any component used in the study
  • Administered with systemic anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drug or steroid ) or topical anti-inflammatory drugs on target knee within 7 days prior to administration in the study
  • With serious prior or ongoing 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, 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 patient
  • With any evidence of malignant disease with life expectancy of less than 1 year
  • Pregnant or lactating women or planning to be pregnant during the study period
  • With body mass index (BMI) greater or equal to 35 kg/m2
  • With joint diseases except knee osteoarthritis considered by investigator not eligible to enter the study
  • With known history of human immunodeficiency virus (HIV) infection.
  • Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
  • With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
  • Having participated other investigational study within 4 weeks of entering this study
  • With known history of claustrophobia
  • Having any existing active/inactive implanted medical devices, such as cardiac pacemaker, cochlear, intracranial vascular clips or neurostimulator, etc...
  • Having any existing metallic intraocular foreign body

Treatment and study plan

Elixcyte 8 ml

Biological

ADSC 6.4*10^7 cells, allogeneic injection

Hya Joint Plus

Device

Hya Joint Plus synovial fluid supplement 3mL, SciVision Biotech Inc.

Elixcyte 4 ml

Biological

ADSC 3.2*10^7 cells, allogeneic injection

Elixcyte 2 ml

Biological

ADSC 1.6*10^7 cells, allogeneic injection

Primary outcomes

  1. Changes from baseline to post-treatment visit of WOMAC pain score at week 24 after treatment

    Time frame: Weeks 0, 24

  2. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Week 48

Secondary outcomes

  1. Changes from baseline to post-treatment visits of Visual Analogue Scale (VAS) to measure Pain Levels

    Time frame: Weeks 0, 2, 4, 12, 24, 36, 48

  2. Changes from baseline to post-treatment visits of scores of sections in Knee Society Clinical Rating System (KSCRS) Score

    Time frame: Weeks 0, 2, 4, 12, 24, 36, 48

  3. Changes from baseline to post-treatment visits of MRI examination results

    Time frame: Weeks 0, 24, 48, 72, 96

  4. Changes from baseline to post-treatment visits of total score, and sub-scores of all sections in WOMAC

    Time frame: Weeks 0, 2, 4, 12, 36, 48

  5. Total acetaminophen consumption amount during the first 48 weeks and week 48 to week 96

    Time frame: Week 0, 2, 4, 12, 24, 48, 96

  6. Total non-steroidal anti-inflammatory drug (NSAID) consumption amount during the first 48 weeks and week 48 to week 96

    Time frame: Weeks 0, 2, 4, 12, 24

  7. Time to subject first time consumes acetaminophen

    Time frame: Weeks 0, 2, 4, 12, 24

  8. Time to subject first time consumes non-steroidal anti-inflammatory drug (NSAID)

    Time frame: Weeks 0, 2, 4, 12, 24

  9. Number of patients with clinically abnormal laboratory values and/or adverse events that are related to treatment

    Time frame: Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96

  10. Number of patients with clinically abnormal vital signs and/or adverse events that are related to treatment

    Time frame: Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96

  11. Changes from baseline to week 96 visit in cartilage thickness in the total femorotibial joint by centralized (independent) imaging interpretation.

    Time frame: Weeks 0, 24, 48, 72, 96

Sponsors and collaborators

Lead sponsor

UnicoCell Biomed CO. LTD

Industry

Collaborators

  • A2 Healthcare Taiwan Corporation

Registry information

Official study title

A Phase I/II Study to Evaluate the Safety and Efficacy of the Allogeneic Injection of Expanded Adipose-derived Stem Cells to Patients With Knee Osteoarthritis

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
May 27, 2016
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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