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

Primary Purpose

Moderate to Severe Chronic Kidney Disease

Status

Unknown status

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

ELIXCYTE

About this trial

This is an interventional treatment trial for Moderate to Severe Chronic Kidney Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Taipei Medical University Shuang Ho HospitalRecruiting
Chang Gung Memorial Hospital LinkouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Low dose:

Middle dose

High dose

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

for Phase I

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

or Phase II

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02933827

First Posted

October 13, 2016

Last Updated

November 4, 2020

Sponsor

UnicoCell Biomed CO. LTD

Collaborators

Protech Pharmaservices Corporation (PPC)

1. Study Identification

Unique Protocol Identification Number

NCT02933827

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

April 23, 2019 (Actual)

Study Completion Date

January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UnicoCell Biomed CO. LTD

Collaborators

Protech Pharmaservices Corporation (PPC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Moderate to Severe Chronic Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low dose:

Arm Type

Experimental

Arm Description

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

Arm Title

Middle dose

Arm Type

Experimental

Arm Description

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

Arm Title

High dose

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ELIXCYTE

Intervention Description

Adipose-derived stem cells (ADSCs)

Primary Outcome Measure Information:

Title

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

Description

for Phase I

Time Frame

Week 48

Title

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

Description

or Phase II

Time Frame

Week 0, 24

Secondary Outcome Measure Information:

Title

Change from baseline to all post-treatment visits in creatinine

Time Frame

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

Title

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

Time Frame

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

Title

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

Time Frame

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

Title

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

Title

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

Title

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

Title

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

Time Frame

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

Title

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

Title

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

Title

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

Time Frame

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

Title

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

Time Frame

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

Title

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

Time Frame

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

Title

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

Title

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

Time Frame

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

Title

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

Title

Change from baseline to all post-treatment visits in eGFR

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eva Chen

Phone

+886-2-2791-1826

Ext

158

eva@unicocell.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mai-Szu Wu, PhD

Organizational Affiliation

Taipei Medical University Shuang Ho Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taipei Medical University Shuang Ho Hospital

City

New Taipei City

ZIP/Postal Code

235

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mai-Szu Wu, PhD

maiszuwu@s.tmu.edu.tw

First Name & Middle Initial & Last Name & Degree

Mai-Szu Wu, PhD

Facility Name

Chang Gung Memorial Hospital Linkou

City

Taoyuan City

ZIP/Postal Code

333

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ya-Chung Tian, PhD

Phone

886-3-328-1200

Ext

8181

dryctian@cgmh.org.tw

First Name & Middle Initial & Last Name & Degree

Ya-Chung Tian, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35415928

Citation

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.

Results Reference

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

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