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

NCT02933827 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CT31
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

Brief Summary

1. 1.To assess the safety of allogeneic injection of expanded ADSCs to patients with Moderate to Severe Chronic Kidney Disease
2. 2.To assess the efficacy of allogeneic injection of expanded ADSCs to patients with Moderate to Severe Chronic Kidney Disease

Conditions

Moderate to Severe Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• 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

Study Arms (3)

Low dose:

EXPERIMENTAL

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

Drug: ELIXCYTE

Middle dose

EXPERIMENTAL

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

Drug: ELIXCYTE

High dose

EXPERIMENTAL

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

Drug: ELIXCYTE

Interventions

ELIXCYTE DRUG

Adipose-derived stem cells (ADSCs)

High dose; Low dose:; Middle dose

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UnicoCell Biomed CO. LTD: lead

Study Sites (3)

Taipei Medical University Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

Chang Gung Memorial Hospital Linkou

Taoyuan, 333, Taiwan

Location

Related Publications (2)

• Lin YC, Hung YP, Tian YC, Wu MJ, Lin HC, Chen SY, Wu MS, Chiou HY. Real-World Data as External Control in Assessing the Efficacy of Allogeneic Adipose-Derived Stem Cells Therapy for Advanced Chronic Kidney Disease. Clin Transl Sci. 2025 Dec;18(12):e70415. doi: 10.1111/cts.70415.

  PMID: 41299839 DERIVED

• 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.

  PMID: 35415928 DERIVED

Study Officials

• Mai-Szu Wu, PhD

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 14, 2016
• Study Start: May 1, 2018
• Primary Completion: April 23, 2019
• Study Completion: June 21, 2023
• Last Updated: February 9, 2024

Record last verified: 2020-11

Locations

TW (3)