UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021426
Receipt number R000024200
Scientific Title Angiogenic Therapy Against Peripheral Arterial Disease with bone marrow derived MSC grown in platelet-rich plasma
Date of disclosure of the study information 2016/03/14
Last modified on 2018/09/21 11:46:30

* 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

Angiogenic Therapy Against Peripheral Arterial Disease with bone marrow derived MSC grown in platelet-rich plasma

Acronym

ATPAD

Scientific Title

Angiogenic Therapy Against Peripheral Arterial Disease with bone marrow derived MSC grown in platelet-rich plasma

Scientific Title:Acronym

ATPAD

Region

Japan


Condition

Condition

Peripheral arterial disease

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess safety of angiogenic therapy against peripheral arterial disease with bone marrow derived mesenchymal stem cell grown in platelet-rich plasma

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the frequency of occurrence of the adverse event of grade 2 or more on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 during 1 year after post treatment

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

Injection 0.3 to 0.5 ml cultivated bone marrow cell from about 1.0 x 107-8 as total volume about 10 to 50 ml of suspending liquid to muscle of ischemic leg using 27G needle.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

>= grade III of Fontain's classification,
>= grade II-4 of Rutherford's Classification

Key exclusion criteria

* The patient with remarkable short life expectancy
* Patient with the past which is alcohol or drug dependence within 3 months of past
* Patient with malignant neoplasms and the patient who has the past within 5 years
* The patient who judged that there was a possibility of the malignant tumor
* Patient with severe diabetic retinopathy
* The patient who can't get informed consent
* The patient who judged that he was unsuitable to this trial

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shoji Fukuda

Organization

National Center for Global Health and Medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

1-21-1 Toyama, Shinjuku, Tokyo 162-8655

TEL

03-3202-7181

Email

sfukuda@hosp.ncgm.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kanae Endo

Organization

National Center for Global Health and Medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

1-21-1 Toyama, Shinjuku, Tokyo 162-8655

TEL

03-3202-7181

Homepage URL

http://www.hosp.ncgm.go.jp/s023/200/index.html

Email

shinzou.gimu@hosp.ncgm.go.jp


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

National Center for Global Health and 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

YES

Study ID_1

RM27-003

Org. issuing International ID_1

NA8140003

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 03 Month 14 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 01 Month 19 Day

Date of IRB


Anticipated trial start date

2016 Year 03 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

Registration 6
Complete 5


Management information

Registered date

2016 Year 03 Month 10 Day

Last modified on

2018 Year 09 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024200


Research Plan
Registered date File name
2017/03/15 ①_6血管新生研究計画書_Ver_2.5.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name