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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UnicoCell Biomed CO. LTD
• Collaborators: A2 Healthcare Taiwan Corporation; Protech Pharmaservices Corporation (PPC)

Criteria

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