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

February 6, 2024 updated by: UnicoCell Biomed CO. LTD

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 235
        • Taipei Medical University Shuang Ho Hospital
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

A patient is eligible for the study if all of the followings apply:

  1. Aged 20-80 years (inclusive)
  2. With chronic kidney disease (CKD)stage 3B to 4 (eGFR 15 to 44 mL/min/1.73m2 (inclusive)) Note : eGFR = estimated glomerular filtration rate
  3. Having provided informed consent

Exclusion Criteria:

Any patient meeting any of the exclusion criteria will be excluded from study participation.

  1. Ascertained hypersensitivity to any component used in the study Note: including gentamicin, DMSO, Agglutex (heperin)
  2. With inadequate hematologic function with: absolute neutrophil count (ANC) <1,500/μL OR platelets < 100,000/μL OR Hemoglobin < 8 g/dL
  3. 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)
  4. With hemoglobin A1c (HbA1c) > 8.0%
  5. 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
  6. Pregnant or lactating women or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period
  7. With body mass index (BMI) greater or equal to 36 kg/m2
  8. With known history of human immunodeficiency virus (HIV) infection or any type of hepatitis
  9. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
  10. With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
  11. Having participated other investigational study within 4 weeks of entering this study
  12. Known or suspected abuse of alcohol or narcotics
  13. With known history of cancer within past 5 years
  14. With any autoimmune disease
  15. With cystic kidney disease or requiring kidney dialysis
  16. With precancerous condition or with cancer within past 5 years before Screening visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low dose:
ELIXCYTE 8 mL (ADSC 6.4*10^7 cells in total)
Drug: ELIXCYTE
Adipose-derived stem cells (ADSCs)
Experimental: Middle dose
ELIXCYTE 24 mL (ADSC 19.2*10^7 cells in total)
Drug: ELIXCYTE
Adipose-derived stem cells (ADSCs)
Experimental: High dose
ELIXCYTE 40 mL (ADSC 32.0*10^7 cells in total)
Drug: ELIXCYTE
Adipose-derived stem cells (ADSCs)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Week 48
for Phase I
Week 48
Change from baseline to Week 24 visit in estimated glomerular filtration rate (eGFR)
Time Frame: Week 0, 24
or Phase II
Week 0, 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline to all post-treatment visits in creatinine
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in blood urea nitrogen (BUN)
Time Frame: Weeks 2, 4, 12, 24, 36, 48
Weeks 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in blood cystatin C
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in urine total protein-creatinine ratio (UPCR)
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in plasma neutrophil gelatinase-associated lipocalin (NGAL) by enzyme-linked immunosorbent assay (ELISA)
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in urine kidney injury molecule-1(KIM-1)
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in urine interleukin 18 (IL-18)
Time Frame: Weeks 2, 4, 12, 24, 36, 48
Weeks 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in urine liver-type fatty acid-binding protein (L-FABP)
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in urine neutrophil gelatinase-associated lipocalin (NGAL)
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in urine cystatin C
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in hemoglobin A1c
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in fasting plasma glucose
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48
Percentage of patients with hypoglycemia (defined as blood glucose < 55 mg/dL or 3.0 mmol/L) at all post-treatment visits
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in body weight
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in urine microalbumin-to-creatinine ratio (UMCR)
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in eGFR
Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48
Weeks 0, 2, 4, 12, 24, 36, 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UnicoCell Biomed CO. LTD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Protech Pharmaservices Corporation (PPC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mai-Szu Wu, PhD, Taipei Medical University Shuang Ho Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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