Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 47 of 523 for:    stem cell kidney

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02933827
Recruitment Status : Recruiting
First Posted : October 14, 2016
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Protech Pharmaservices Corporation (PPC)
Information provided by (Responsible Party):
UnicoCell Biomed CO. LTD

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

Condition or disease Intervention/treatment Phase
Moderate to Severe Chronic Kidney Disease Drug: ELIXCYTE Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Low dose:
ELIXCYTE 8 mL (ADSC 6.4*10^7 cells in total)
Drug: ELIXCYTE
Adipose-derived stem cells (ADSCs)

Experimental: Middle dose
ELIXCYTE 24 mL (ADSC 19.2*10^7 cells in total)
Drug: ELIXCYTE
Adipose-derived stem cells (ADSCs)

Experimental: High dose
ELIXCYTE 40 mL (ADSC 32.0*10^7 cells in total)
Drug: ELIXCYTE
Adipose-derived stem cells (ADSCs)




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Week 48 ]
    for Phase I

  2. Change from baseline to Week 24 visit in estimated glomerular filtration rate (eGFR) [ Time Frame: Week 0, 24 ]
    or Phase II


Secondary Outcome Measures :
  1. Change from baseline to all post-treatment visits in creatinine [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  2. Change from baseline to all post-treatment visits in blood urea nitrogen (BUN) [ Time Frame: Weeks 2, 4, 12, 24, 36, 48 ]
  3. Change from baseline to all post-treatment visits in blood cystatin C [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. Change from baseline to all post-treatment visits in urine interleukin 18 (IL-18) [ Time Frame: Weeks 2, 4, 12, 24, 36, 48 ]
  8. 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 ]
  9. 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 ]
  10. Change from baseline to all post-treatment visits in urine cystatin C [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  11. Change from baseline to all post-treatment visits in hemoglobin A1c [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  12. Change from baseline to all post-treatment visits in fasting plasma glucose [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  13. 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 ]
  14. Change from baseline to all post-treatment visits in body weight [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  15. 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 ]
  16. Change from baseline to all post-treatment visits in eGFR [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933827


Contacts
Layout table for location contacts
Contact: Eva Chen +886-2-2791-1826 ext 158 eva@unicocell.com

Locations
Layout table for location information
Taiwan
Taipei Medical University Shuang Ho Hospital Recruiting
New Taipei City, Taiwan, 235
Contact: Mai-Szu Wu, PhD       maiszuwu@s.tmu.edu.tw   
Principal Investigator: Mai-Szu Wu, PhD         
Chang Gung Memorial Hospital Linkou Not yet recruiting
Taoyuan City, Taiwan, 333
Contact: Ya-Chung Tian, PhD    886-3-328-1200 ext 8181    dryctian@cgmh.org.tw   
Principal Investigator: Ya-Chung Tian, PhD         
Sponsors and Collaborators
UnicoCell Biomed CO. LTD
Protech Pharmaservices Corporation (PPC)
Investigators
Layout table for investigator information
Principal Investigator: Mai-Szu Wu, PhD Taipei Medical University Shuang Ho Hospital

Layout table for additonal information
Responsible Party: UnicoCell Biomed CO. LTD
ClinicalTrials.gov Identifier: NCT02933827     History of Changes
Other Study ID Numbers: CT31
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency