Assessment of the safety of a cell-based therapy on reducing the deterioration of kidney function in patients with kidney disease
| ISRCTN | ISRCTN13142863 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13142863 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/01/2015
- Registration date
- 24/02/2015
- Last edited
- 15/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Public
Chang Gung Memorial Hospital
123 Ta Pei Road
Niao Sung District
Kaohsiung
833
Taiwan
 ORCID ID |
0000-0002-6305-5717 |
|---|---|
| Phone | +886-7-7317123 (extension 8300) |
| han.gung@msa.hinet.net |
Study information
| Study design | Interventional single-arm single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | Chang Gung Memorial Hospital, 24/09/2014, 102-0358A |
| Health condition(s) or problem(s) studied | Chronic kidney disease |
| Intervention | Intrarenal artery infusion of CD34+ endothelial progenitor cells |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/08/2014 |
| Completion date | 31/07/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/09/2014 |
| Date of final enrolment | 31/05/2016 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Niao Sung District
Kaohsiung
833
Taiwan
Sponsor information
Hospital/treatment centre
123 Ta Pei Road
Niao Sung District
Kaohsiung City
833
Taiwan
| Phone | +886-7-7317123 |
|---|---|
| han.gung@msa.hinet.net | |
"ROR" |
https://ror.org/02verss31 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | We will publish and disseminate our study results before 31/12/2017. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/03/2017 | 15/02/2022 | Yes | No |
Editorial Notes
15/02/2022: Publication reference and total final enrolment added.
