UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023282
Receipt No. R000026841
Scientific Title Therapeutic Angiogenesis using Autologous Bone-Marrow Mononuclear Cells Implantation
Date of disclosure of the study information 2016/07/22
Last modified on 2016/07/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Therapeutic Angiogenesis using Autologous Bone-Marrow Mononuclear Cells Implantation
Acronym Therapeutic Angiogenesis using Autologous Bone-Marrow Mononuclear Cells Implantation
Scientific Title Therapeutic Angiogenesis using Autologous Bone-Marrow Mononuclear Cells Implantation
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Satoaki Matoba
Organization Kyoto Prefectural University School of Medicine
Division name Cardiovascular Medicine
Zip code
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
1st name
Middle name
Last name Kenji Yanishi
Organization Kyoto Prefectural University School of Medicine
Division name Cardiovascular Medicine
Zip code
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

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
2016 Year 07 Month 22 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 No longer recruiting
Date of protocol fixation
2016 Year 04 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.