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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2023-06-21

Brief Summary

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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

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Detailed Description

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Conditions

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Moderate to Severe Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low dose:

ELIXCYTE 8 mL (ADSC 6.4\*10\^7 cells in total)

Group Type EXPERIMENTAL

ELIXCYTE

Intervention Type DRUG

Adipose-derived stem cells (ADSCs)

Middle dose

ELIXCYTE 24 mL (ADSC 19.2\*10\^7 cells in total)

Group Type EXPERIMENTAL

ELIXCYTE

Intervention Type DRUG

Adipose-derived stem cells (ADSCs)

High dose

ELIXCYTE 40 mL (ADSC 32.0\*10\^7 cells in total)

Group Type EXPERIMENTAL

ELIXCYTE

Intervention Type DRUG

Adipose-derived stem cells (ADSCs)

Interventions

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ELIXCYTE

Adipose-derived stem cells (ADSCs)

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No