UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021374
Receipt number R000024652
Scientific Title Ex Vivo Expanded Erythroblast-Transplantation for patient with critical limb ischemia
Date of disclosure of the study information 2016/03/07
Last modified on 2021/09/23 10:06:26

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Basic information

Public title

Ex Vivo Expanded Erythroblast-Transplantation for patient with critical limb ischemia

Acronym

EVEETA study

Scientific Title

Ex Vivo Expanded Erythroblast-Transplantation for patient with critical limb ischemia

Scientific Title:Acronym

EVEETA study

Region

Japan


Condition

Condition

Peripheral Arterial Disease (PAD) , Buerger disease, and arteritis associated with collagen diseases (Fontaines stage: III and IV)

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigated the safety and efficacy of angiogenic cell therapy by implantation of ex vivo expanded immature erythroblasts cultured from autologous bone marrow cells for patient with critical limb ischemia

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

improvement of skin perfusion pressure level at ischemic leg 1 month after EVEETA

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

Other

Interventions/Control_1

1)Autologous Bone Marrow Collection: 40 to 60 ml of bone marrow is collected from iliaccrest under local anaesthesia 14 days before the implantation.
2)Ex vivo expanded immature erythroblasts from autologous bone marrow cells : All procedures are enforced by exclusive
technical exparts along the approved protocols in GMP-grade Cell Processing Room established in Bioscience Medical Research Center, Niigata University Medical and Dental Hospital. Mononuclear cells separated from the bone marrow are incubated in a suspension culture in the presence of rh Flt-ligand, rh SCF, rh Thrombopoietin, and culture supplements for 7 days to expand myeloid progenitors. Harvested and washed cells are further cultured in the presence of rh SCF, rh IGF-I, rh Erythropoietin, and culture supplements for additional 7 days to expand immature erythroblasts and macrophages. Cultured cells are finally harvested, washed, suspended in 50 ml of autologous platelet rich plasma, and transferred from the bio clean room to bedside.
3)Transplantation of cultured cell: Aliquots of the 50 ml of cell suspension are intramuscularly injected in 100 points of the ischaemic limb. Daily intramuscular injection of 6000 IU of rh erythropoietin in the same loci follows from day 0 for consecutive 5 days.

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

Peripheral Arterial Disease (PAD) , Buerger disease, and arteritis associated with collagen diseases
1. Fontaines stage: III and IV
2. Patient with critical limb ischemia, who were not candidates for endovascular treatment /surgical revascularisation, or skin perfusion pressure<40mmHg at ischemic leg even after endovascular treatment /surgical revascularisation
4. Age: greater than 20 or less than 80 years

Key exclusion criteria

1. Patients with the expected rest of their life less than 1 year
2. Patients with drug dependence during the past 3 months
3. Patients with malignant evidence of malignant disorder during the past 5 years
4. Patients with poorly controlled diabetes mellitus accompanied with proliferative retinopathy
5. Patients with polycythemia; Hematcrit >55%(male), >50%(female)
6. Patients without informed consent
7. Pregnant or possibly pregnant females
8. Patients with acute myocardial infarction, unstable angina, myocarditis, or cerebral infarction during the past 1 month
9. Patients with active infection including Treponema pallidum, or positive test for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
10. Patients with history of allergy for antibiotics
11. Patients with anemia or thrombocytopenia
12. Patients judged inappropriate for this study by phisician
13. Patients without agreement for including in this study

Target sample size

11


Research contact person

Name of lead principal investigator

1st name Tohru
Middle name
Last name Minamino

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Department of Cardiovascular Biology and Medicine

Zip code

9518510

Address

1-754 Asahimachi-Dori, Niigata, Japan

TEL

0252272185

Email

tminamino@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name Takao
Middle name
Last name Yanagawa

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Department of Cardiovascular Biology and Medicine

Zip code

9518510

Address

1-754 Asahimachi-Dori, Niigata, Japan

TEL

0252272185

Homepage URL


Email

takao-ya@med.niigata-u.ac.jp


Sponsor or person

Institute

EVEETA Study Group

Institute

Department

Personal name



Funding Source

Organization

JSPS KAKENHI Grant Numbers 15K09117

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyushu University Hospitals Specially Certified Committee for Regenerative Medicine

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN

Tel

092-642-5774

Email

byskenkyu@jimu.kyushu-u.ac.jp


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 03 Month 07 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

Terminated

Date of protocol fixation

2015 Year 08 Month 20 Day

Date of IRB

2016 Year 01 Month 28 Day

Anticipated trial start date

2016 Year 03 Month 07 Day

Last follow-up date

2020 Year 06 Month 30 Day

Date of closure to data entry

2020 Year 06 Month 30 Day

Date trial data considered complete

2020 Year 06 Month 30 Day

Date analysis concluded

2020 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 03 Month 07 Day

Last modified on

2021 Year 09 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024652


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name