UMIN-CTR Clinical Trial

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
Email	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
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	Kyoto Prefectural University School of Medicine
Address	Kawaramachi, Kamigyoku, Kyoto 6028566 Japan
Tel	075-251-5111
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031381