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
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
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
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
