UMIN-CTR Clinical Trial

Basic information
Public title	G-CSF mobilized CD34+ cell transplantation for hemodialysis patients with critical limb ischemia.
Acronym	CD34+ cell transplantation for HD patients with CLI.
Scientific Title	G-CSF mobilized CD34+ cell transplantation for hemodialysis patients with critical limb ischemia.
Scientific Title:Acronym	CD34+ cell transplantation for HD patients with CLI.
Region	Japan

Condition
Condition	peripheral arterial disease (critical limb ischemia)
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of safety and efficacy of G-CSF mobilized autologous peripheral blood derived CD34+ cell transplantation in hemodialysis patients with critical limb ischemia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	safety evaluation of the therapy for 52 weeks
Key secondary outcomes	1) improvement in Fontaine classification 2) improvement in Rutherford classification 3) visual analogue scale 4) ulcer size 5) physiological tests (ABI/TBI/SPP/TCPo2) 6) major/minor amputation 7) mortality rate 8) cardiovascular event rate 9) amputation-free survival rate

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	intra-muscular injection of G-CSF mobilized autologous peripheral blood derived CD34+ cell.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) angiographically proven occlusion or stenosis more than 70% in SFA, or below knee arteries 2) under maintenance hemodialysis 3) Rutherford grou 3 or 4 4) no indication of endovascular therapy or bypass 5) aged 20-80 6) written informed consent from patient himself
Key exclusion criteria	1) patient with Rutherford group 6 2) patient with Buerger disease 3) patient on peritoneal dialysis 4) low cardiac function (EF < 25%) 5) malignancy or history of malignancy within 5 years 6) advanced diabetic nephropathy 7) interstitial peumonia 8) white blood cell below 3000/uL or above 15000/uL
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shuzo Kobayashi
Organization	Shonan Kamakura General Hospital
Division name	Nephrology
Zip code
Address	1370-1 Okamoto, Kamakura, Kanagawa
TEL	0467-46-1717
Email	shuzo@shonankamakura.or.jp

Public contact
1st name of contact person	1st name Middle name Last name Takayasu Ohtake
Organization	Shonan Kamakura General Hospital
Division name	Nephrology
Zip code
Address	1370-1 Okamoto, Kamakura, Kanagawa
TEL	0467-46-1717
Homepage URL
Email	ohtake@shonankamakura.or.jp

Sponsor
Institute	Shonan Kamakura General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	湘南鎌倉総合病院

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 27 Day
Date of IRB	2014 Year 03 Month 27 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2017 Year 04 Month 30 Day
Date of closure to data entry	2017 Year 07 Month 31 Day
Date trial data considered complete	2017 Year 08 Month 31 Day
Date analysis concluded	2017 Year 10 Month 15 Day

Other
Other related information	The results of this trial has been published in the following paper; Ohtake T, Mochida Y, Ishioka K, et al: Autologous granulocyte colony-stimulating factor-mobilized peripheral blood CD34 positive cell transplantation for hemodialysis patients with critical limb ischemia: A prospective phase II clinical trial. Stem Cells Transl Med. 7:1-9, 2018.

Management information
Registered date	2014 Year 09 Month 26 Day
Last modified on	2019 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017752