UMIN-CTR Clinical Trial

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

CLI(Critical limb ischemia) (ASO, Buerger disease, Collagen disease)

Classification by specialty

Cardiology

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Evaluation of rest pain using Numerical Rating Scale

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyoto Prefectural University School of Medicine

Institute

Department

Personal name

Organization

Kyoto Prefectural University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

07

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

07

Month

22

Day

Last modified on

2016

Year

07

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026841