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

Study Overview
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Brief Summary
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To assess the safety of allogeneic injection of expanded ADSCs to patients with Moderate to Severe Chronic Kidney Disease To assess the efficacy of allogeneic injection of expanded ADSCs to patients with Moderate to Severe Chronic Kidney Disease

Official Title
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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

Conditions
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Moderate to Severe Chronic Kidney Disease

Intervention / Treatment
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* Drug: ELIXCYTE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose:<br>ELIXCYTE 8 mL (ADSC 6.4*10^7 cells in total) | Drug: ELIXCYTE<br>* Adipose-derived stem cells (ADSCs)<br>|
| Experimental: Middle dose<br>ELIXCYTE 24 mL (ADSC 19.2*10^7 cells in total) | Drug: ELIXCYTE<br>* Adipose-derived stem cells (ADSCs)<br>|
| Experimental: High dose<br>ELIXCYTE 40 mL (ADSC 32.0*10^7 cells in total) | Drug: ELIXCYTE<br>* Adipose-derived stem cells (ADSCs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | for Phase I | Week 48 | 
| Change from baseline to Week 24 visit in estimated glomerular filtration rate (eGFR) | or Phase II | Week 0, 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to all post-treatment visits in creatinine |  | Weeks 0, 2, 4, 12, 24, 36, 48 | 
| Change from baseline to all post-treatment visits in blood urea nitrogen (BUN) |  | Weeks 2, 4, 12, 24, 36, 48 | 
| Change from baseline to all post-treatment visits in blood cystatin C |  | Weeks 0, 2, 4, 12, 24, 36, 48 | 
| Change from baseline to all post-treatment visits in urine total protein-creatinine ratio (UPCR) |  | 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) |  | Weeks 0, 2, 4, 12, 24, 36, 48 | 
| Change from baseline to all post-treatment visits in urine kidney injury molecule-1(KIM-1) |  | Weeks 0, 2, 4, 12, 24, 36, 48 | 
| Change from baseline to all post-treatment visits in urine interleukin 18 (IL-18) |  | 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) |  | Weeks 0, 2, 4, 12, 24, 36, 48 | 
| Change from baseline to all post-treatment visits in urine neutrophil gelatinase-associated lipocalin (NGAL) |  | Weeks 0, 2, 4, 12, 24, 36, 48 | 
| Change from baseline to all post-treatment visits in urine cystatin C |  | Weeks 0, 2, 4, 12, 24, 36, 48 | 
| Change from baseline to all post-treatment visits in hemoglobin A1c |  | Weeks 0, 2, 4, 12, 24, 36, 48 | 
| Change from baseline to all post-treatment visits in fasting plasma glucose |  | 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 |  | Weeks 0, 2, 4, 12, 24, 36, 48 | 
| Change from baseline to all post-treatment visits in body weight |  | Weeks 0, 2, 4, 12, 24, 36, 48 | 
| Change from baseline to all post-treatment visits in urine microalbumin-to-creatinine ratio (UMCR) |  | Weeks 0, 2, 4, 12, 24, 36, 48 | 
| Change from baseline to all post-treatment visits in eGFR |  | Weeks 0, 2, 4, 12, 24, 36, 48 |