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Knee OsteoarthritisPhase 1/2NCT02784964

Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis

A Phase 1/2 study testing Elixcyte 8 ml, Hya Joint Plus and Elixcyte 4 ml in people with Knee Osteoarthritis, run by UnicoCell Biomed CO. LTD at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Elixcyte 8 ml, Hya Joint Plus and Elixcyte 4 ml
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
2 sitesTaiwan
Study dates
Mar 2016to Jun 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Taipei Veterans General Hospital

    Taipei, 112

  • Chang Gung Memorial Hospital Linkou

    Taoyuan City, 333

Other trials in Taiwan

About this study

Official 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

  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
Being tested
Elixcyte 8 ml, Hya Joint Plus, Elixcyte 4 ml, Elixcyte 2 ml
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elixcyte 8 mlBiological

    ADSC 6.4*10^7 cells, allogeneic injection

  • Hya Joint PlusDevice

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

  • Elixcyte 4 mlBiological

    ADSC 3.2*10^7 cells, allogeneic injection

  • Elixcyte 2 mlBiological

    ADSC 1.6*10^7 cells, allogeneic injection

Study groups in NCT02784964
Study groupRoleWhat they receive
Elixcyte 8mLExperimentalADSC 6.4*10^7 cells, allogeneic injection, one time injection on Day 1
Receives: Biological: Elixcyte 8 ml
Hya Joint PlusActive comparatorHya Joint Plus synovial fluid supplement 3mL, SciVision Biotech Inc., one time injection on Day 1
Receives: Device: Hya Joint Plus
Elixcyte 4mLExperimentalADSC 3.2*10^7 cells, allogeneic injection, one time injection on Day 1
Receives: Biological: Elixcyte 4 ml
Elixcyte 2mLExperimentalADSC 1.6*10^7 cells, allogeneic injection, one time injection on Day 1
Receives: Biological: Elixcyte 2 ml

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Weeks 0, 24

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

    Measured: Week 48

Secondary outcomes (11)

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

    Measured: 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

    Measured: Weeks 0, 2, 4, 12, 24, 36, 48

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

    Measured: 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

    Measured: Weeks 0, 2, 4, 12, 36, 48

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

    Measured: 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

    Measured: Weeks 0, 2, 4, 12, 24

  7. Time to subject first time consumes acetaminophen

    Measured: Weeks 0, 2, 4, 12, 24

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

    Measured: Weeks 0, 2, 4, 12, 24

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

    Measured: 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

    Measured: 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.

    Measured: Weeks 0, 24, 48, 72, 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionJul 2018
  4. Study completionJun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02784964
Sponsor's protocol ID
CT21
Status last verified
Nov 2020
First submitted
16 May 2016
Last updated
15 Jul 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Chen CF, Hu CC, Wu CT, Wu HH, Chang CS, Hung YP, Tsai CC, Chang Y. Treatment of knee osteoarthritis with intra-articular injection of allogeneic adipose-derived stem cells (ADSCs) ELIXCYTE(R): a phase I/II, randomized, active-control, single-blind, multiple-center clinical trial. Stem Cell Res Ther. 2021 Oct 30;12(1):562. doi: 10.1186/s13287-021-02631-z.

    PubMed 34717765

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Elixcyte 8 ml, Hya Joint Plus and Elixcyte 4 ml in people with Knee Osteoarthritis, run by UnicoCell Biomed CO. LTD at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline to post-treatment visit of WOMAC pain score at week 24 after treatment (time frame: Weeks 0, 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02784964, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.

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