UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027383 |
|---|---|
| Receipt number | 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 | 2020/05/20 14:27:55 |
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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 | Satoaki |
| Middle name | |
| Last name | Matoba |
Organization
Kyoto Prefectural University School of Medicine
Division name
Cardiovascular Medicine
Zip code
6028566
Address
Kawaramachi, Kamigyoku, Kyoto 6028566 Japan
TEL
0752515511
matoba@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Yanishi |
Organization
Kyoto Prefectural University School of Medicine
Division name
Cardiovascular Medicine
Zip code
6028566
Address
Kawaramachi, Kamigyoku, Kyoto 6028566 Japan
TEL
075-251-5511
Homepage URL
yanishi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University School of Medicine
Institute
Department
Personal name
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
Kyoto Prefectural University School of Medicine
Address
Kawaramachi, Kamigyoku, Kyoto 6028566 Japan
Tel
075-251-5111
yanishi@koto.kpu-m.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
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 | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
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
| 2020 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031381
| Research Plan | |
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| Registered date | File name |
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