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

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: Completed
• Conditions: Moderate to Severe Chronic Kidney Disease
• Intervention / Treatment: Drug: ELIXCYTE

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Eva Chen; Phone Number: 158 +886-2-2791-1826; Email: eva@unicocell.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	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

Collaborators and Investigators

• Sponsor: UnicoCell Biomed CO. LTD
• Collaborators: Protech Pharmaservices Corporation (PPC)
• Investigators: Principal Investigator: Mai-Szu Wu, PhD, Taipei Medical University Shuang Ho Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): April 23, 2019
• Study Completion (Actual): June 21, 2023

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimated): October 14, 2016

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID 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