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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027383
Receipt No. R000031381
Scientific Title Therapeutic angiogenesis using autologous bone marrow mononuclear cells implantation for Buerger disease
Date of disclosure of the study information 2017/05/18
Last modified on 2017/05/18

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Basic information
Public title Therapeutic angiogenesis using autologous bone marrow mononuclear cells implantation for Buerger disease
Acronym Therapeutic angiogenesis using autologous bone marrow mononuclear cells implantation for Buerger disease
Scientific Title Therapeutic angiogenesis using autologous bone marrow mononuclear cells implantation for Buerger disease
Scientific Title:Acronym Therapeutic angiogenesis using autologous bone marrow mononuclear cells implantation for Buerger disease
Region
Japan

Condition
Condition CLI(Critical limb ischemia) (Buerger disease)
Classification by specialty
Cardiology Clinical immunology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of the safety and efficacy of therapeutic angiogenesis using autologous bone marrow mononuclear cell for CLI due to Buerger disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The amount of change of SPP from registration to 6 months after implantation
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
Maneuver
Interventions/Control_1 Therapeutic angiogenesis using autologous bone marrow mononuclear 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) Age is aged 20 and over and a less than 80 years old patient.
2) Sex does not ask.
3) Buerger disease with Fontaine classification III or IV.
4) The affected side SPP at the time of registration is 30 mmHg.
5) The patient by whom it was checked that I enforce all the standard treatments by which insurance was carried out, and there is no recovery.
6) I am related with the profits and the disadvantage which arises by receiving a cell transplant, and the profits and the disadvantage which arise by not receiving a cell transplant,the patient who is given to sufficient explanation with a consent explanatory note document and from whom the document consent to test participation is acquired based on the patient's himself intention (those who need care and care need an understanding and consent of a family for the person himself/herself).
Key exclusion criteria 1. Even if the disease and the way type are suitable, or informed consent is not obtained from a patient, it is feelings consideration to a patient family.
When I am required and it is difficult to be adapted.
2. When diagnosed as malignant tumor by inspections.
3. When it has ischemic cardiopathy and blood circulation reconstruction is not performed.
4. Serious illness diabetic retinopathy with no treatment.
5. When it has serious infection.
6. When critical impaired liver function and renal dysfunction (maintenance dialysis patient removes)exist.
7. When serious anemia which needs blood dyscrasia and transfusion with white corpuscle reduction,critical decrease of platelets, etc. exists.
8. Nursing mother when there are under pregnancy and possibility of pregnancy.
9. Simultaneous with the final examination, or those to the final examination that incorporated and participated in other clinical tests of trial drug or products on the market (medical equipment is included) within 30 days.
10. When the serious anemia which needs blood dyscrasia and transfusion with white corpuscle reduction, a critical decrease of platelets, etc. exists.
11. There are other acute and chronic medical serious and mental state, and abnormalities in a clinical laboratory test result. Danger may increase by test participation. The patient who may have on the interpretation of a test result. The patient to whom the examination responsibility (assignment) doctor judged the participation in the final examination to be unsuitable.
12. In addition, when a family doctor and a medical specialist judge it as a stop.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoaki Matoba
Organization Kyoto Prefectural University School of Medicine
Division name Cardiovascular Medicine
Zip code
Address Kawaramachi, Kamigyoku, Kyoto 6028566 Japan
TEL 0752515511
Email matoba@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Yanishi
Organization Kyoto Prefectural University School of Medicine
Division name Cardiovascular Medicine
Zip code
Address Kawaramachi, Kamigyoku, Kyoto 6028566 Japan
TEL 075-251-5511
Homepage URL
Email yanishi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University School of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 18 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 Preinitiation
Date of protocol fixation
2017 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 18 Day
Last modified on
2017 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031381

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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