UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Therapeutic Angiogenesis using Autologous Bone-Marrow Mononuclear Cells Implantation
Title of the study (Brief title)	Therapeutic Angiogenesis using Autologous Bone-Marrow Mononuclear Cells Implantation
Region	Japan

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

Objectives
Narrative objectives1	Examination of the safety and efficacy of therapeutic angiogenesis using autologous BMMNCs(Bone-Marrow Mononuclear Cell) for CLI.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of rest pain using Numerical Rating Scale
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 BMMNCs(Bone-Marrow Mononuclear Cell) for CLI.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1,Adaptation standard : An adaptation standard belongs to Fontaine classification III, degree of IV, and Rutherford classification II degree 4 group, III degree 5 group, and six groups. At the time of quiet At the patient who has sharp pain or an ischemic ulcer, they are medical and surgery. Patient by whom there is no adaptation of the-like blood circulation reconstruction way, and cutting will be expected in the future. A blood vessel rebirth does not have complications which can serve as an aggravation factor, but conflicts with exclusion criteria. What is not carried out. 2,Selection-criterion: 1) Age is aged 20 and over and a less than 80-year-old patient. Sex does not ask. 2) The patient who fulfills one conditions of the followings by the patient to whom the obstacle of the everyday life is remarkably carried out by the serious illness leg ischemia of Fontaine III-IV. A) A living guidance, medication, percutaneous-transluminal-angioplasty way, and bypass hand including prohibition of smoking Way - Patient by whom recovery is not seen in the cure from the former called a nerve knot block etc. B) it is judged by a vascular surgeon and the circulatory organ physician that there is no adaptation of a blood circulation reconstruction way -- the patient to whom cutting will be obliged from now on. 3) A document fully explains the complications, the profits, and the disadvantage by the effect, side effects, and operation which arises in a cell transplant, and it is based on an understanding and consent of the patient's himself will, and a family, and is cell transplant medical treatment. Patient whom I wish and by whom written consent is got.
Key exclusion criteria	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	120

Research contact person
Name of lead principal investigator	Satoaki Matoba
Organization	Kyoto Prefectural University School of Medicine
Division name	Cardiovascular Medicine
Address	Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566 Japan
TEL	075-251-5511
Email	matoba@koto.kpu-m.ac.jp

Public contact
Name of contact person	Kenji Yanishi
Organization	Kyoto Prefectural University School of Medicine
Division name	Cardiovascular Medicine
Address	Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566 Japan
TEL	075-251-5511
Homepage URL
Email	yanishi@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	2016 Year 07 Month 22 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 04 Month 25 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 22 Day
Last modified on	2016 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026841