Application of peripheral blood-derived stem cell (CD34⁺) therapy on chronic kidney disease

ISRCTN	ISRCTN15592135
DOI	https://doi.org/10.1186/ISRCTN15592135
Secondary identifying numbers	TFDA No. 105IND04085

Submission date: 30/07/2018
Registration date: 22/08/2018
Last edited: 11/08/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
Chronic kidney disease (CKD) is a long-term disease in which the kidneys do not function effectively. The incidence of CKD is much higher in Taiwan than in other countries. End-stage CKD is where almost all kidney function is lost and patients have to rely on dialysis to remove waste products from the blood. Various drugs can be used to slow down deterioration of kidney function, but cannot reverse or cure the progression of CKD. Additionally, patients with CKD can have poor responses to these treatments. An alternative is stem cell therapy, where stem cells (cells capable of developing into other types of cell) to replace damaged kidney cells. The aim of this study is to look at the efficacy of stem cell therapy for reducing the deterioration of kidney function in patients with CKD.

Who can participate?
Patients aged 20-80 years with chronic kidney disease

What does the study involve?
The participants are randomly allocated to one of two groups, either the study group or the control group. The study group will receive standard medication for CKD, along with stem cell therapy, whereas the control group will receive standard medication only.es standard medical therapy. All participants will receive 1 year of follow-up to assess their kidney function.

What are the possible benefits and risks of participating?
The possible benefit of participating is that participants may have improved kidney function as a result. The possible risks of participating are haematoma, contrast-induced nephropathy, malignancy, pain, sepsis and artery dissection.

Where is the study run from?
Kaohsiung Chang Gung Memorial Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
January 2016 to December 2020

Who is funding the study?
Chang Gung Memorial Hospital, Chang Gung Medical Foundation (Taiwan)

Who is the main contact?
Prof. Hon-Kan Yip
han.gung@msa.hinet.net

Contact information

Prof Hon-Kan Yip
Scientific

No. 123, Ta Pei Road Niao Sung District
Kaohsiung City
83301
Taiwan

Study information

Study design	Interventional prospective single-center randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available
Scientific title	Application of peripheral blood-derived stem cell/progenitor cell (CD34⁺) therapy on chronic kidney disease: Phase 2 clinical trial
Study hypothesis	The peripheral blood-derived stem cell/progenitor cell (CD34⁺) may be a therapeutic option for patients with chronic kidney disease
Ethics approval(s)	Chang Gung Memorial Hospital No. 201600371A0, 19/05/2016, 201600371A0 Taiwan FDA, 23/08/2016, 105IND04085
Condition	Chronic kidney disease
Intervention	Participants will be evenly divided into the intervention group and the controlled group using the envelope method. Participants in the intervention group will receive standard medication for chronic kidney disease, along with the administration of blood-derived stem cell/progenitor cell (CD34⁺) therapy, while the control group will receive only standard medication. Standard medication includes angiotensin-converting-enzyme inhibitors (ACEI), angiotensin II receptor blockers (ARB), dopamine reuptake inhibitors (DRI), beta-blockers or calcium channel blockers (CCB) to maintain normal blood pressure within a range of less than 140/90 mmHg. All participants will receive a 1 year follow up period, where participants will undergo blood biochemistry tests, renal ultrasounds and vital signs will be monitored at 1 week and 3, 6, 9 and 12 months after the intervention period.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Peripheral blood-derived stem cells/progenitor cells (CD34⁺)
Primary outcome measure	Improvement of Ccr (creatinine clearance rate cc/min) from the baseline, assessed using serum creatine levels at the baseline, and after 1 week and 1, 3, 6, 9 and 12 months
Secondary outcome measures	1. Reduction of proteinuria value (albumin/creatinine ratio), assessed at the baseline, and after 1 week and 1, 3, 6, 9 and 12 months. The albumin concentration per creatine level in urea is assessed using the microalbumin test and the urine protein/creatinine ratio is assessed by the Urine Protein-Creatinine Ratio (UPCR) test. 2. Incidence of renal failure (either requiring haemodialysis or causing death) within the 1 year follow-up period
Overall study start date	31/01/2016
Overall study end date	31/12/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	56 subjects (28 subjects for treatment group and 28 subjects for control group)
Total final enrolment	52
Participant inclusion criteria	1. Aged 20-80 years old 2. Renal failure due to hypertension 3. Receiving optimal medical therapy (received optimal therapy for more than 12 weeks and have been evaluated by a nephrologist. Medication includes ACEI, ARB, DRI, beta-blocker or CCB. Blood pressure is less than 140/90 mmHg) 4. Renal function between chronic kidney disease (CKD) stage III-IV 5. Stable renal function maintained for 1 year before study (creatinine clearance rate between 15-60 ml/min and no significant changes)
Participant exclusion criteria	1. Pregnant or breastfeeding 2. Infected with HIV 3. Infected with HBV or HCV 4. Myocardial infarction within 3 months prior to study 5. Heart failure (functional class IV) 6. Malignant or hematological disease 7. Severe disease with lifespan less than 1 year 8. End stage renal disease 9. Creatinine clearance rate less than 15 ml/min 10. Kidney disease on only one side 11. Participating in other clinical trials 12. Unable to receive therapies used in this study 13. Organ transplantation 14. Autoimmune disease
Recruitment start date	01/06/2016
Recruitment end date	31/05/2019

Locations

Countries of recruitment

Taiwan

Study participating centre

Kaohsiung Chang Gung Memorial Hospital

No.123, Ta Pei Road, Niao Sung District
Kaohsiung
83301
Taiwan

Sponsor information

Ministry of Science and Technology, Taiwan
Government

No. 106 HoPing E. Road Sec.2
Taipei
10622
Taiwan

Phone	+886-2-2737-7992
Email	misservice@most.gov.tw
Website	https://www.most.gov.tw/
"ROR"	https://ror.org/02kv4zf79

Funders

Funder type

Not defined

Ministry of Science and Technology (105-2325-B-182A-002 -)

No information available

Chang Gung Medical Research Program Grant

No information available

Results and Publications

Intention to publish date	31/12/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a peer reviewed journal in 2020
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		16/04/2020	20/01/2022	Yes	No

Editorial Notes

10/08/2022: Internal review.
20/01/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added.