Adipose-derived Stem Cells (ADSCs) for Moderate to Severe... | NCT02933827

NCT02933827

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ELIXCYTE	Drug	Adipose-derived stem cells (ADSCs)	High dose Low dose: Middle dose

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

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

Name	Affiliation	Role
Mai-Szu Wu, PhD	Taipei Medical University Shuang Ho Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Medical University Shuang Ho Hospital		New Taipei City		235	Taiwan
Taichung Veterans General Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41299839	Derived	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.
35415928	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.