Clinical Trials List
Protocol NumberCT31
2018-01-01 - 2022-01-31
Phase I
Recruiting3
ICD-10N18
Chronic kidney disease (CKD)
ICD-9585
Chronic renal failure
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
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Trial Applicant
PROTECH PHARMASERVICES CORPORATION
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Sponsor
-
Trial scale
Taiwan Multiple Center
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Update
2023/03/10
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- CHENG-HSU CHEN Division of Nephrology
- 蔡尚峰 Division of Nephrology
- 吳軍毅 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Mei-Yi Wu Division of Nephrology
- YUNG-HO HSU Division of Nephrology
- Yu-Wei Chen Division of Nephrology
- Cai-Mei Zheng Division of Nephrology
The Actual Total Number of Participants Enrolled
15 Recruiting
Audit
None
Condition/Disease
Moderate to Severe Chronic Kidney Disease (stage 3B to 4)
Objectives
Primary Objectives
To assess the safety of allogeneic infusion of ADSCs to patients with moderate to severe CKD
Secondary Objectives
To assess the efficacy of allogeneic infusion of ADSCs to patients with moderate to severe CKD
Test Drug
ELIXCYTE
Active Ingredient
Dosage Form
Dosage
Elixcyte 8mL, 6.4*107
Elixcyte 24mL, 19.2*107
Elixcyte 24mL, 19.2*107
Endpoints
Primary endpoints
The primary endpoints for this study are:
Phase I
1. Incidence of adverse events (AEs) and serious adverse events (SAEs)
Phase II
1. Change from baseline to Week 24 visit in estimated glomerular filtration rate
(eGFR)
Secondary efficacy endpoints
The endpoints used to achieve the secondary objectives of this study in the
efficacy profiles are listed below:
1. Change from baseline to all post-treatment visits in creatinine
2. Change from baseline to all post-treatment visits in blood urea nitrogen
(BUN)
3. Change from baseline to all post-treatment visits in blood cystatin C
4. Change from baseline to all post-treatment visits in urine total proteincreatinine ratio (UPCR)
5. Change from baseline to all post-treatment visits in plasma neutrophil
gelatinase-associated lipocalin (NGAL) by enzyme-linked immunosorbent
assay (ELISA)
6. Change from baseline to all post-treatment visits in urine biomarkers such as
kidney injury molecule-1(KIM-1), interleukin 18 (IL-18), liver-type fatty
acid-binding protein (L-FABP), NGAL, cystatin C
7. Change from baseline to all post-treatment visits in hemoglobin A1c
(HbA1c)
8. Change from baseline to all post-treatment visits in fasting plasma glucose
9. Percentage of patients with hypoglycemia (defined as blood glucose < 55
mg/dL or 3.0 mmol/L) at all post-treatment visits
10. Change from baseline to all post-treatment visits in body weight
11. Change from baseline to all post-treatment visits in urine microalbumin-tocreatinine ratio (UMCR)
12. Change from baseline to all post-treatment visits (except Week 24 visit in
both phases) in eGFR
Secondary safety endpoints
The endpoints used to achieve the secondary objectives of this study in the
safety profiles are changes from baseline to post-treatment visits in vital signs,
physical examination, and laboratory examination results.
The primary endpoints for this study are:
Phase I
1. Incidence of adverse events (AEs) and serious adverse events (SAEs)
Phase II
1. Change from baseline to Week 24 visit in estimated glomerular filtration rate
(eGFR)
Secondary efficacy endpoints
The endpoints used to achieve the secondary objectives of this study in the
efficacy profiles are listed below:
1. Change from baseline to all post-treatment visits in creatinine
2. Change from baseline to all post-treatment visits in blood urea nitrogen
(BUN)
3. Change from baseline to all post-treatment visits in blood cystatin C
4. Change from baseline to all post-treatment visits in urine total proteincreatinine ratio (UPCR)
5. Change from baseline to all post-treatment visits in plasma neutrophil
gelatinase-associated lipocalin (NGAL) by enzyme-linked immunosorbent
assay (ELISA)
6. Change from baseline to all post-treatment visits in urine biomarkers such as
kidney injury molecule-1(KIM-1), interleukin 18 (IL-18), liver-type fatty
acid-binding protein (L-FABP), NGAL, cystatin C
7. Change from baseline to all post-treatment visits in hemoglobin A1c
(HbA1c)
8. Change from baseline to all post-treatment visits in fasting plasma glucose
9. Percentage of patients with hypoglycemia (defined as blood glucose < 55
mg/dL or 3.0 mmol/L) at all post-treatment visits
10. Change from baseline to all post-treatment visits in body weight
11. Change from baseline to all post-treatment visits in urine microalbumin-tocreatinine ratio (UMCR)
12. Change from baseline to all post-treatment visits (except Week 24 visit in
both phases) in eGFR
Secondary safety endpoints
The endpoints used to achieve the secondary objectives of this study in the
safety profiles are changes from baseline to post-treatment visits in vital signs,
physical examination, and laboratory examination results.
Inclution Criteria
Main inclusion criteria:
A patient is eligible for the study if all of the followings apply:
(1)Aged 20-80 years (inclusive).
(2)With 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.
A patient is eligible for the study if all of the followings apply:
(1)Aged 20-80 years (inclusive).
(2)With 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
Main 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
Withdrawal Criteria:
Patients may be withdrawn from the trial due to any of the following conditions:
(1)Patient decides to withdraw her/his informed consent form.
(2)Investigator considers that the patient is no longer physically and/or psychologically feasible to remain in the study.
(3)Patient refuses to keep appointment or to proceed with critical measures for the study endpoints, defined as all variables required for primary endpoint evaluation.
(4)Patient develops adverse effects that the investigator considers a permanent cessation of the study treatment is necessary.
(5)Patient has lost of follow-up
(6)The patient needs a medicine or other medical treatment that is not allowed in the study.
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
Withdrawal Criteria:
Patients may be withdrawn from the trial due to any of the following conditions:
(1)Patient decides to withdraw her/his informed consent form.
(2)Investigator considers that the patient is no longer physically and/or psychologically feasible to remain in the study.
(3)Patient refuses to keep appointment or to proceed with critical measures for the study endpoints, defined as all variables required for primary endpoint evaluation.
(4)Patient develops adverse effects that the investigator considers a permanent cessation of the study treatment is necessary.
(5)Patient has lost of follow-up
(6)The patient needs a medicine or other medical treatment that is not allowed in the study.
The Estimated Number of Participants
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Taiwan
44 participants
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Global
0 participants
