Moderate to Severe Chronic Kidney Disease Clinical Trial
Official title:
A Phase I/II Study to Evaluate the Safety and Efficacy of Allogeneic Infusion of Adipose-Derived Stem Cells in Moderate to Severe Chronic Kidney Disease
| Verified date | November 2020 |
| Source | UnicoCell Biomed CO. LTD |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 39 |
| Est. completion date | June 21, 2023 |
| Est. primary completion date | April 23, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Taipei Medical University Shuang Ho Hospital | New Taipei City | |
| Taiwan | Taichung Veterans General Hospital | Taichung | |
| Taiwan | Chang Gung Memorial Hospital Linkou | Taoyuan City |
| Lead Sponsor | Collaborator |
|---|---|
| UnicoCell Biomed CO. LTD |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of adverse events (AEs) and serious adverse events (SAEs) | for Phase I | Week 48 | |
| Primary | Change from baseline to Week 24 visit in estimated glomerular filtration rate (eGFR) | or Phase II | Week 0, 24 | |
| Secondary | Change from baseline to all post-treatment visits in creatinine | Weeks 0, 2, 4, 12, 24, 36, 48 | ||
| Secondary | Change from baseline to all post-treatment visits in blood urea nitrogen (BUN) | Weeks 2, 4, 12, 24, 36, 48 | ||
| Secondary | Change from baseline to all post-treatment visits in blood cystatin C | Weeks 0, 2, 4, 12, 24, 36, 48 | ||
| Secondary | Change from baseline to all post-treatment visits in urine total protein-creatinine ratio (UPCR) | Weeks 0, 2, 4, 12, 24, 36, 48 | ||
| Secondary | 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 | ||
| Secondary | Change from baseline to all post-treatment visits in urine kidney injury molecule-1(KIM-1) | Weeks 0, 2, 4, 12, 24, 36, 48 | ||
| Secondary | Change from baseline to all post-treatment visits in urine interleukin 18 (IL-18) | Weeks 2, 4, 12, 24, 36, 48 | ||
| Secondary | 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 | ||
| Secondary | Change from baseline to all post-treatment visits in urine neutrophil gelatinase-associated lipocalin (NGAL) | Weeks 0, 2, 4, 12, 24, 36, 48 | ||
| Secondary | Change from baseline to all post-treatment visits in urine cystatin C | Weeks 0, 2, 4, 12, 24, 36, 48 | ||
| Secondary | Change from baseline to all post-treatment visits in hemoglobin A1c | Weeks 0, 2, 4, 12, 24, 36, 48 | ||
| Secondary | Change from baseline to all post-treatment visits in fasting plasma glucose | Weeks 0, 2, 4, 12, 24, 36, 48 | ||
| Secondary | 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 | ||
| Secondary | Change from baseline to all post-treatment visits in body weight | Weeks 0, 2, 4, 12, 24, 36, 48 | ||
| Secondary | Change from baseline to all post-treatment visits in urine microalbumin-to-creatinine ratio (UMCR) | Weeks 0, 2, 4, 12, 24, 36, 48 | ||
| Secondary | Change from baseline to all post-treatment visits in eGFR | Weeks 0, 2, 4, 12, 24, 36, 48 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00479024 -
Follow-up Study to Previous CARE Trial
|
N/A |