UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013820 |
|---|---|
| Receipt number | R000016065 |
| Scientific Title | Autologous mesenchymal cell implantation in patients with peripheral artery disease (Arteriosclerosis obliterans, Buerger's disease, collagen disease) |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2019/05/01 14:04:06 |
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Basic information
Public title
Autologous mesenchymal cell implantation in patients with peripheral artery disease (Arteriosclerosis obliterans, Buerger's disease, collagen disease)
Acronym
Autologous mesenchymal cell implantation in patients with peripheral artery disease
Scientific Title
Autologous mesenchymal cell implantation in patients with peripheral artery disease (Arteriosclerosis obliterans, Buerger's disease, collagen disease)
Scientific Title:Acronym
Autologous mesenchymal cell implantation in patients with peripheral artery disease
Region
| Japan |
Condition
Condition
Peripheral artery disease (arteriosclerosis obliterans, Buerger's disease, collagen disease)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the efficacy to improve limb blood flow and safety of autologous mesenchymal cell implantation in patients with peripheral artery disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Safety
a) Adverse event, side effect
b) Laboratory data
2) Efficacy
Primary outcomes (6 months after implantation)
Improvement of symptom or physical examination according to Fontaine classification at baseline
a) Fontaine IIb: >20% improvement of initial claudication distance or absolute claudication distance
b) Fontaine III: >2cm improvement of visual analogue scale
c) Fontaine IV: >25% reduction of ulcer size in patients with ulcer or free of major amputation in patients with gangrene
Key secondary outcomes
Base
Study type
Interventional
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
Autologous mesenchymal cell implantation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) written informed consent
2) >20 years of age
3) rest pain, ulcer or gangrene accompanying by stenosis or occlusion of arteries either superficial femoral artery, popliteal artery or below the knee artery
4) not applicable for endovascular therapy or bypass surgery
Key exclusion criteria
1) having malignancy
2) prior myocardial infarction, unstable angina, myocarditis, cerebrovascular infarction within 2 months
3) activating inflammation
4) possible pregnancy
5) activating proliferative retinopathy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Suzuki |
Organization
Showa University Fujigaoka Hospital
Division name
Deartment of Invernal Medicine, Division of Cardiology
Zip code
227-8501
Address
1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa
TEL
0459711151
hrsuzuki@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Suzuki |
Organization
Showa University Fujigaoka Hospital
Division name
Deartment of Invernal Medicine, Division of Cardiology
Zip code
Hiroshi
Address
1-30 Fujigaoka, Aoba-ku, Yokohama 227-8501, Japan
TEL
045-971-1151
Homepage URL
http://www.f-circ.com/
hrsuzuki@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Fujigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University Fujigaoka Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Child Health and Development
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Fujigaoka Hospital
Address
1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa
Tel
045-971-1151
hrsuzuki@med.showa-u.ac.jp
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
昭和大学藤が丘病院
Showa University Fujigaoka Hospital
独立行政法人国立成育医療研究センター
National Center for Child Health and Development
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | 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
| 2013 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 27 | Day |
Last modified on
| 2019 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016065
