UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005227 |
|---|---|
| Receipt number | R000006213 |
| Scientific Title | Transplantation of autologous and G-CSF mobilized mononuclear cells in patients with critical limb ischemia (CLI) |
| Date of disclosure of the study information | 2011/03/09 |
| Last modified on | 2013/12/19 16:52:08 |
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Basic information
Public title
Transplantation of autologous and G-CSF mobilized mononuclear cells in patients with critical limb ischemia (CLI)
Acronym
G-CSF mobilized MNC therapy in CLI patients
Scientific Title
Transplantation of autologous and G-CSF mobilized mononuclear cells in patients with critical limb ischemia (CLI)
Scientific Title:Acronym
G-CSF mobilized 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 G-CSF mobilized 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
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
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
Subcutaneous administration of G-CSF, Harvest 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) Aherosclerotic 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 old 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 allergic reactions or side effects to G-CSF preparations or apheresis
5) Patients with malignant tumor
6) Patients with diabetic proliferating retinopathy (new Fukuda classification ii to BV)
7) Less than 3 months since last episode of unstable angina and myocardial/cerebral infarction
8) Patients with hematological disease (leukemia, myeloproliferative disease, myelodysplastic syndromes or sickle cell anemia)
9) Patients with collagen diseases
10) Patients with cirrhosis of the liver
11) Patients currently suffering from or having a history of interstitial pneumonitis
12) Patients with cerebral aneurysm judged to require treatment by a neurosurgeon
13) Leukocytes less than 4,000/micro L or exceeding 15,000/micro LL
14) Platelets less than 100,000/micro L
15) Hemoglobin less than 8 g/dL
16) AST(GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L
17) Patients for whom abdominal CT reveals splenomegaly
18) Patients with rest pain, ulcer or necrosis for reasons other than CLI (such as lumber spinal canal stenosis, arthropathy or vasculitis),
19) 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
20) Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period
21) Patients enrolled in any other clinical trial
22) 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
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
t-ito@fbri.org
Sponsor or person
Institute
Regenerative Medicine Unit, Division of Vascular Regeneration Therapy, Institute of Biomedical Research and Innovation (IBRI)
Institute
Department
Personal name
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
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 Regeneration Therapy, Institute of Biomedical Research and Innovation (IBRI)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 09 | Day |
Related information
URL releasing protocol
http://www.ibri-kobe.org/leg/treatment/index.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
| 2012 | Year | 07 | Month | 04 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 23 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 09 | Day |
Last modified on
| 2013 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006213
