UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009943
Receipt number R000011647
Scientific Title Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease
Date of disclosure of the study information 2013/12/01
Last modified on 2017/02/05 17:10:43

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Basic information

Public title

Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease

Acronym

Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease

Scientific Title

Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease

Scientific Title:Acronym

Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease

Region

Japan


Condition

Condition

Peripheral Arterial Disease (Fontaine stages three and four)

Classification by specialty

Cardiology Vascular surgery Orthopedics
Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We have reported that mesenhymal stem cells (MSC)could differentiate into vascular endothelial cells and produce vascular endothelial grows factor.The aim of this study is to investigate the efficacy and safety of culture expanded MSC for the treatments of peripheral artery disease. The MSC is derived from small amount(about 20ml) of patient's bone marrow cells and will be injected into the same patient's limb

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

ABI(Ankle Brechial Pressure Index): 7days, 1,6 and 12 months post transplantation.
Angiography : 12 months post transplantation.

Key secondary outcomes

Walking time without pain using tredmil: 1, 6 and 12 months post transplantation


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

Medicine

Interventions/Control_1

Bone marrow of about 20ml is taken from the patient. The bone marrow is transferred to National Institute of Advanced Industrial Science and Technology (AIST) at Amagasaki city and cultured to expand the mesenchymal stem cell. The stem cell is transferred back to the hospital. Half ml of mesenchymal stem cells (2.5 x 106 cells/ml) is injected into ischemic area of lower extremity. The injection sites per extremity are about 40. When both extremities show ischemic change, more severe extremity is selected. If some clinical effect after the injection appear but not satisfactory, several repeated injection will be done, furthermore, if injection into other extremity is thought to be effective, another injection is done for this extremity. Total duration of the injection is within a half year after the first injection of the MSCs.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Peripheral Artery Disease: PAD
(2) Fontaine stages III and IV (ABI less than 0.6)
(3) The patient showing contraindications of angioplasty and bypass surgery due to spread areas of stricture or the stricture in small peripheral artery. Patients already treated with such angioplasty and bypass surgery, but showing the symptoms corresponding to above category (2).
(4) The patients by whom written consent is got from himself/herself by aged 20 and over (at the time of consent acquisition).

Key exclusion criteria

(1) The patient of hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) infection, and adult T-cell leukemia
(2) The hypersensitivity to a cow or pig origin protein, the patient that has the past of side effects
(3) The patient showing severe cardiac failure evidenced by cardiac echo examination.
(4) Malignant diseases.
(5) High-risk retinopathy
(6) Serious problems of liver and renal function
(7) Interstitial pneumonia.
(8) Blood diseases such as anemia and leykocytosis.
(9) A pregnant woman, a nursing mother, the patient that may have become pregnant, the female patient who is planning pregnancy by the end of this treatment term.
(10) In addition, the patient whom the principal investigator or the researcher judged to be unsuitable based on the medical rationale

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hajime Ohgushi

Organization

Ookuma Hospital

Division name

Department of Orthopedics

Zip code


Address

2-17-13 Kuise-honmachi, Amagasaki City, Hyogo 660-0814, JAPAN

TEL

06+64811667

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Narita

Organization

Rogenkai Welfare Group

Division name

Headquarters

Zip code


Address

4-27-6 Higashi- sonoda -cho, Amagasaki, City, Hyogo 661-0953, JAPAN

TEL

06+64158590

Homepage URL


Email

narita@ookuma.or.jp


Sponsor or person

Institute

Rogenkai Welfare Group

Institute

Department

Personal name



Funding Source

Organization

National Institute of Advanced Industrial Science and Technology (AIST)

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Institute of Advanced Industrial Science and Technology (AIST)

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

2013 Year 12 Month 01 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

Completed

Date of protocol fixation

2013 Year 02 Month 03 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 21 Day

Last follow-up date

2016 Year 11 Month 12 Day

Date of closure to data entry

2016 Year 11 Month 12 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 02 Month 03 Day

Last modified on

2017 Year 02 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011647


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name