Plain English Summary
Background and study aims
The prevalence and incidence of chronic kidney disease (CKD), a long-term disease in which the kidneys do not work effectively, in Taiwan are much higher than in other countries. The incidence of end-stage renal disease (ESRD), when the kidneys stop working properly for an individual to live without dialysis or a transplant, in Taiwan is the highest in the world. The advances in drug treatments might slow the deterioration of the kidney function, but cannot reverse or cure the progression of CKD. Since patients who have CKD have poor responses to medications for the prevention of kidney function deterioration, stem cell therapy might be an alternative choice for them. The aim in this study is to assess the safety of this therapy on reducing the deterioration of kidney function in patients with CKD.
Who can participate?
Patients 20–80 years old, with chronic kidney disease due to increased blood pressure (hypertension)
What does the study involve?
Endothelial progenitor cells will be injected in the right artery of the kidney
What are the possible benefits and risks of participating?
The benefit is an improvement in renal function. The risks are bleeding, haematoma, contrast-induced nephropathy, malignancy, pain, sepsis, and artery dissection.
Where is the study run from?
Chang Gung Memorial Hospital (Taiwan).
When is the study starting and how long is it expected to run for?
From August 2014 to July 2017
Who is funding the study?
Chang Gung Memorial Hospital (Taiwan)
Who is the main contact?
Dr Hon-Kan Yip
han.gung@msa.hinet.net
Trial website
Contact information
Type
Public
Primary contact
Dr Hon-Kan Yip
ORCID ID
http://orcid.org/0000-0002-6305-5717
Contact details
Chang Gung Memorial Hospital
123 Ta Pei Road
Niao Sung District
Kaohsiung
833
Taiwan
+886-7-7317123 (extension 8300)
han.gung@msa.hinet.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Therapeutic potential of CD34+ endothelial progenitor cell therapy on attenuating the deterioration of kidney function in patients with chronic kidney disease: a safety analysis
Acronym
Study hypothesis
The prognosis of patients with chronic kidney disease (CKD) and other co-morbidities, like sepsis, coronary artery disease, heart failure with pulmonary oedema, are worse than those without CKD, and the mortality rate in patients with CKD are also very high during hospitalisation. Finding a new, effective and safe strategic management is of the utmost importance for patients, nephrologists and physicians and is important to reduce the medical costs in Taiwan. The causes of CKD are divergent and varied, including hypertension, diabetes mellitus and dyslipidaemia, and they initiate endothelial cell dysfunction and propagation of obstructive atherosclerosis. Additionally, inadequate use of drugs might also cause progressive loss of the renal microvasculature, which leads to hypoxia in local tissue and induction of fibrotic responses, scarring and deterioration of renal function.
Results from experimental studies have shown that stem cell therapy improves ischaemia-related organ dysfunction. Also, many clinical trials have shown that both endothelial progenitor cells (EPCs) and mesenchymal stem cells (MSCs), which are derived from bone marrow, peripheral blood or adipose tissue, significantly improve left ventricular function in acute myocardial infarction or chronic ischaemic heart disease. In human studies, the number and function of EPCs decrease significantly in patients with CKD. Studies of animal models have shown stem cell therapy restores renal function in chronic CKD. No data have been reported for human CKD.
Hypothesis: CD34+ endothelial progenitor cell therapy can safely attenuate the deterioration of kidney function in patients with CKD.
Ethics approval
Chang Gung Memorial Hospital, 24/09/2014, 102-0358A
Study design
Interventional single-arm single-centre trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic kidney disease
Intervention
Intrarenal artery infusion of CD34+ endothelial progenitor cells
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measure
Percentage of patients with an improvement of 5 mL/min in creatinine clearance rate after CD34+ cell treatment at baseline and at 1 week, 1 month, 3 months, 6 months, 9 months and 12 months after therapy
Secondary outcome measures
Significant reductions in:
1. Proteinuria, will be measured every day after therapy for 3 days
2. Creatinine, will be measured every day after therapy for 3 days
3. Combined secondary end-point, defined as acute renal failure with requirement for haemodialysis, or death, at 1 week, 1 month, 3 months, 6 months, 9 months and 12 months after therapy
Overall trial start date
01/08/2014
Overall trial end date
31/07/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 20–80 years old
2. Chronic kidney disease due to hypertension after optimum drug therapy
3. Chronic kidney disease, stage III–IV with stable renal function within 1 year
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Younger than 20 years old or older than 80 years old
2. Pregnant or breastfeeding women
3. Infections (e.g., with human immunodeficiency virus [HIV])
4. Myocardial infarction or congestive heart failure (functional class IV) within 3 months
5. Malignancy
6. Other severe organ failure
7. Life expectancy of less than 1 year
8. End-stage renal disease
Recruitment start date
24/09/2014
Recruitment end date
31/05/2016
Locations
Countries of recruitment
Taiwan
Trial participating centre
Chang Gung Memorial Hospital
123 Ta Pei Road
Niao Sung District
Kaohsiung
833
Taiwan
Sponsor information
Organisation
Chang Gung Memorial Hospital
Sponsor details
123 Ta Pei Road
Niao Sung District
Kaohsiung City
833
Taiwan
+886-7-7317123
han.gung@msa.hinet.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Chang Gung Memorial Hospital (Taiwan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We will publish and disseminate our study results before 31/12/2017.
Intention to publish date
31/12/2017
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list