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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Adipose-derived stem cells (ADSCs)
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Chang Gung Memorial Hospital Linkou
Taoyuan City, Taiwan
Incidence of adverse events (AEs) and serious adverse events (SAEs)
for Phase I
Time frame: Week 48
Change from baseline to Week 24 visit in estimated glomerular filtration rate (eGFR)
or Phase II
Time frame: Week 0, 24
Change from baseline to all post-treatment visits in creatinine
Time frame: Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in blood urea nitrogen (BUN)
Time frame: Weeks 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in blood cystatin C
Time frame: Weeks 0, 2, 4, 12, 24, 36, 48
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
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
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
Change from baseline to all post-treatment visits in urine interleukin 18 (IL-18)
Time frame: Weeks 2, 4, 12, 24, 36, 48
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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
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
Change from baseline to all post-treatment visits in urine cystatin C
Time frame: Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in hemoglobin A1c
Time frame: Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in fasting plasma glucose
Time frame: 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
Time frame: Weeks 0, 2, 4, 12, 24, 36, 48
Change from baseline to all post-treatment visits in body weight
Time frame: Weeks 0, 2, 4, 12, 24, 36, 48
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
Change from baseline to all post-treatment visits in eGFR
Time frame: Weeks 0, 2, 4, 12, 24, 36, 48