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

UnicoCell Biomed

Status and phase: Completed; Phase 2; Phase 1

Conditions: Moderate to Severe Chronic Kidney Disease

Treatments: Drug: ELIXCYTE

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02933827

CT31

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

Low dose:

Experimental group

Description:

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

Treatment:

Drug: ELIXCYTE

Middle dose

Experimental group

Description:

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

Treatment:

Drug: ELIXCYTE

High dose

Experimental group

Description:

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

Treatment:

Drug: ELIXCYTE