UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015266
Receipt number R000017752
Scientific Title G-CSF mobilized CD34+ cell transplantation for hemodialysis patients with critical limb ischemia.
Date of disclosure of the study information 2014/10/01
Last modified on 2019/04/03 15:51:26

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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

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

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 or person

Institute

Shonan Kamakura General Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017752


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name