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Moderate to Severe Chronic Kidney DiseasePhase 1/2NCT02933827

Adipose-derived Stem Cells (ADSCs) for Moderate to Severe Chronic Kidney Disease

A Phase 1/2 study testing ELIXCYTE in people with Moderate to Severe Chronic Kidney Disease, run by UnicoCell Biomed CO. LTD at 3 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 Moderate to Severe Chronic Kidney Disease 2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with Moderate to Severe Chronic Kidney Disease Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
ELIXCYTE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
3 sitesTaiwan
Study dates
1 May 2018to 21 Jun 2023
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A patient is eligible for the study if all of the followings apply:
  • Aged 20-80 years (inclusive)
  • With chronic kidney disease (CKD)stage 3B to 4 (eGFR 15 to 44 mL/min/1.73m2 (inclusive)) Note : eGFR = estimated glomerular filtration rate
  • Having provided informed consent

Who cannot join

  • Any patient meeting any of the exclusion criteria will be excluded from study participation.
  • Ascertained hypersensitivity to any component used in the study Note: including gentamicin, DMSO, Agglutex (heperin)
  • With inadequate hematologic function with: absolute neutrophil count (ANC) <1,500/μL OR platelets < 100,000/μL OR Hemoglobin < 8 g/dL
  • With inadequate hepatic function with: serum bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (AKP) > 2.5 x the institutional upper limit of normal (ULN)
  • With hemoglobin A1c (HbA1c) > 8.0%
  • 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, ECG 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
Show all 17Show fewer
  • Pregnant or lactating women or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period
  • With body mass index (BMI) greater or equal to 36 kg/m2
  • With known history of human immunodeficiency virus (HIV) infection or any type of hepatitis
  • 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
  • Known or suspected abuse of alcohol or narcotics
  • With known history of cancer within past 5 years
  • With any autoimmune disease
  • With cystic kidney disease or requiring kidney dialysis
  • With precancerous condition or with cancer within past 5 years before Screening visit

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 235

  • Taichung Veterans General Hospital

    Taichung, 407

  • 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 Allogeneic Infusion of Adipose-Derived Stem Cells in Moderate to Severe Chronic Kidney Disease

  1. To assess the safety of allogeneic injection of expanded ADSCs to patients with Moderate to Severe Chronic Kidney Disease
  2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with Moderate to Severe Chronic Kidney Disease
Being tested
ELIXCYTE

What participants receive

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

  • ELIXCYTEDrug

    Adipose-derived stem cells (ADSCs)

Study groups in NCT02933827
Study groupRoleWhat they receive
Low dose:ExperimentalELIXCYTE 8 mL (ADSC 6.4*10^7 cells in total)
Receives: Drug: ELIXCYTE
Middle doseExperimentalELIXCYTE 24 mL (ADSC 19.2*10^7 cells in total)
Receives: Drug: ELIXCYTE
High doseExperimentalELIXCYTE 40 mL (ADSC 32.0*10^7 cells in total)
Receives: Drug: ELIXCYTE

What is being measured

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

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

    for Phase I

    Measured: Week 48

  2. Change from baseline to Week 24 visit in estimated glomerular filtration rate (eGFR)

    or Phase II

    Measured: Week 0, 24

Secondary outcomes (16)

  1. Change from baseline to all post-treatment visits in creatinine

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

  2. Change from baseline to all post-treatment visits in blood urea nitrogen (BUN)

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

  3. Change from baseline to all post-treatment visits in blood cystatin C

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

  4. Change from baseline to all post-treatment visits in urine total protein-creatinine ratio (UPCR)

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

  5. Change from baseline to all post-treatment visits in plasma neutrophil gelatinase-associated lipocalin (NGAL) by enzyme-linked immunosorbent assay (ELISA)

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

  6. Change from baseline to all post-treatment visits in urine kidney injury molecule-1(KIM-1)

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

  7. Change from baseline to all post-treatment visits in urine interleukin 18 (IL-18)

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

  8. Change from baseline to all post-treatment visits in urine liver-type fatty acid-binding protein (L-FABP)

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

  9. Change from baseline to all post-treatment visits in urine neutrophil gelatinase-associated lipocalin (NGAL)

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

  10. Change from baseline to all post-treatment visits in urine cystatin C

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

  11. Change from baseline to all post-treatment visits in hemoglobin A1c

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

  12. Change from baseline to all post-treatment visits in fasting plasma glucose

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

  13. Percentage of patients with hypoglycemia (defined as blood glucose < 55 mg/dL or 3.0 mmol/L) at all post-treatment visits

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

  14. Change from baseline to all post-treatment visits in body weight

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

  15. Change from baseline to all post-treatment visits in urine microalbumin-to-creatinine ratio (UMCR)

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

  16. Change from baseline to all post-treatment visits in eGFR

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

Timeline

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

  1. First posted14 Oct 2016 (estimated)
  2. Study start1 May 2018
  3. Primary completion23 Apr 2019
  4. Study completion21 Jun 2023

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
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02933827
Sponsor's protocol ID
CT31
Status last verified
Nov 2020
First submitted
13 Oct 2016
Last updated
9 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lin YC, Hung YP, Tian YC, Wu MJ, Lin HC, Chen SY, Wu MS, Chiou HY. Real-World Data as External Control in Assessing the Efficacy of Allogeneic Adipose-Derived Stem Cells Therapy for Advanced Chronic Kidney Disease. Clin Transl Sci. 2025 Dec;18(12):e70415. doi: 10.1111/cts.70415.

    PubMed 41299839

  • Zheng CM, Chiu IJ, Chen YW, Hsu YH, Hung LY, Wu MY, Lin YF, Liao CT, Hung YP, Tsai CC, Cherng YG, Wu MS. Allogeneic adipose tissue-derived stem cells ELIXCYTE(R) in chronic kidney disease: A phase I study assessing safety and clinical feasibility. J Cell Mol Med. 2022 May;26(10):2972-2980. doi: 10.1111/jcmm.17310. Epub 2022 Apr 12.

    PubMed 35415928

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ELIXCYTE in people with Moderate to Severe Chronic Kidney Disease, run by UnicoCell Biomed CO. LTD at 3 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 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: Week 48). 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 NCT02933827, which also lists 2 linked publications.

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 9 Feb 2024.

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