Moderate to Severe Chronic Kidney Disease
Conditions
Brief summary
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
Interventions
DRUGELIXCYTE
Adipose-derived stem cells (ADSCs)
Sponsors
UnicoCell Biomed CO. LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Week 48 | for Phase I |
| Change from baseline to Week 24 visit in estimated glomerular filtration rate (eGFR) | Week 0, 24 | or Phase II |
Secondary
| Measure | Time frame |
|---|---|
| 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 creatinine | 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 |
| 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 blood urea nitrogen (BUN) | Weeks 2, 4, 12, 24, 36, 48 |
Countries
Taiwan
Outcome results
None listed