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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021374
Receipt No. 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 2019/03/11

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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
Institute EVEETA Study Group
Institute
Department

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 Open public recruiting
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
2022 Year 01 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 07 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.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


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