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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005232
Receipt No. R000006209
Scientific Title Transplantation of autologous mononuclear cells in patients with critical limb ischemia (CLI)
Date of disclosure of the study information 2011/03/10
Last modified on 2014/09/10

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Basic information
Public title Transplantation of autologous mononuclear cells in patients with critical limb ischemia (CLI)
Acronym MNC therapy in CLI patients
Scientific Title Transplantation of autologous mononuclear cells in patients with critical limb ischemia (CLI)
Scientific Title:Acronym MNC therapy in CLI patients
Region
Japan

Condition
Condition CLI (atherosclerotic PAD/Buerger disease)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of PB-MNC therapy in no-option patients with CLI
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes We will exploratorily evaluate the following concerns without configuring primary outcomes.
1) Fontaine's grade and Rutherford's category
2) All-cause mortality and cause of death
3) Major amputation and unplanned minor amputation
4) Size of ulcer
5) Severity of ischemic leg pain
6) Physiological findings of lower extremity ischemia
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
Device,equipment Maneuver
Interventions/Control_1 Harves and implantation of PB-MNC
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 1) Atherosclerotic PAD or Buerger's disease with >70% luminal stenosis in the leg arteries by digital subtraction angiography (DSA)
2) >3 months since the onset of lower limb ischemia
3) CLI within category 4-5 on the Rutherford's scale
4) Failure of or no indication for transluminal angioplasty/stenting and bypass surgery
5) 20-80 aged patients who can give informed consent themselves in writing



Key exclusion criteria 1) CLI within category 6 on the Rutherford's scale
2) Less than 3 months since success of bypass surgery, transluminal angioplasty and sympathectomy for the limb expected to be transplanted
3) Left ventricular ejection fraction< 25%
4) Patients with a history of severe side effects to apheresis
5) Patients with malignant tumor
6) Patients with diabetic proliferating retinopathy (new Fukuda classification Bii to BV)
7) Less than 3 months since last episode of unstable angina and myocardial/cerebral infarction
8) Patients with cirrhosis of the liver
9) Leukocytes exceeding 15,000/ micro L
10) Platelets less than 100,000/ micro L
11) Hemoglobin less than 8 g/dL
12) Patients with rest pain, ulcer or necrosis for reasons other than CLI (such as lumber spinal canal stenosis, arthropathy or vasculitis)
13) Patients who require major amputation regardless of whether revascularization is successful or not, because of exposure of the bone or tendon due to osteomyelitis, osteonecrosis, ulcer and soft tissue necrosis, or sepsis
14) Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period
15) Patients enrolled in any other clinical trial
16) Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuhiko Kawamoto
Organization Institute of Biomedical Research and Innovation (IBRI)

Division name Regenerative Medicine Unit
Zip code
Address 2-2 Minatojima-Minamimachi, Chuo-Ku
TEL 078-304-5200
Email kawamoto@fbri.org

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Ito
Organization Institute of Biomedical Research and Innovation (IBRI)
Division name Department of Clinical Trial Support
Zip code
Address 2-2 Minatojima-Minamimachi, Chuo-Ku
TEL 078-304-5200
Homepage URL http://www.ibri-kobe.org/leg/index.html
Email t-ito@fbri.org

Sponsor
Institute Regenerative Medicine Unit, Division of Vascular Regeneration Therapy, Institute of Biomedical Research and Innovation (IBRI)

Institute
Department

Funding Source
Organization Foundation for Biomedical Research and Innovation

Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 公益財団法人先端医療振興財団 先端医療センター病院

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 10 Day

Related information
URL releasing protocol http://www.ibri-kobe.org/leg/treatment/index2.html
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
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2013 Year 12 Month 19 Day
Date of closure to data entry
2014 Year 04 Month 01 Day
Date trial data considered complete
2014 Year 05 Month 01 Day
Date analysis concluded
2014 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 10 Day
Last modified on
2014 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006209

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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