Completed

NCT Number: NCT02933827

Adipose-derived Stem Cells (ADSCs) for 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

Completed

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Key information

Conditions

Moderate to Severe Chronic Kidney Disease

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Taipei Medical University Shuang Ho Hospital, New Taipei City, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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
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

Treatment and study plan

ELIXCYTE

Drug

Adipose-derived stem cells (ADSCs)

Primary outcomes

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

Time frame: Week 48

for Phase I
Change from baseline to Week 24 visit in estimated glomerular filtration rate (eGFR)

Time frame: Week 0, 24

or Phase II

Secondary outcomes

Change from baseline to all post-treatment visits in creatinine

Time frame: 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
Change from baseline to all post-treatment visits in blood cystatin C

Time frame: 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
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
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
Change from baseline to all post-treatment visits in urine interleukin 18 (IL-18)

Time frame: 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
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
Change from baseline to all post-treatment visits in urine cystatin C

Time frame: 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
Change from baseline to all post-treatment visits in fasting plasma glucose

Time frame: 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
Change from baseline to all post-treatment visits in body weight

Time frame: 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
Change from baseline to all post-treatment visits in eGFR

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

Sponsors and collaborators

Lead sponsor

UnicoCell Biomed CO. LTD

Industry

Registry information

Official study 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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2023
First posted: Oct 14, 2016
Registry last updated: Feb 9, 2024

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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View Trial Details

Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

Who can participate

Treatment and study plan

ELIXCYTE

Primary outcomes

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

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

Secondary outcomes

Change from baseline to all post-treatment visits in creatinine

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Change from baseline to all post-treatment visits in eGFR

Sponsors and collaborators

Lead sponsor

Registry information

Official study title

Important dates

Related clinical trials

Follow-up Study to Previous CARE Trial