UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021422 |
|---|---|
| Receipt number | R000024714 |
| Scientific Title | Bone marrow mononuclear cell implantation for patients with critical limb ischemia |
| Date of disclosure of the study information | 2016/03/10 |
| Last modified on | 2019/03/11 10:13:51 |
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Basic information
Public title
Bone marrow mononuclear cell implantation for patients with critical limb ischemia
Acronym
BMI study
Scientific Title
Bone marrow mononuclear cell implantation for patients with critical limb ischemia
Scientific Title:Acronym
BMI 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 efficacy of angiogenic cell therapy by implantation of bone marrow mononuclear cell for patient with critical limb ischemia.
Basic objectives2
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 BMI
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
Under general anesthesia, between 500 and 1,000 ml of bone marrow is collected from each patient. The mononuclear cells are separated to 95% purity and are concentrated to produce a final volume of about 50 ml. The cells are implanted into the ischemic leg by means of an intramuscular injection within 3h of the marrow collection.
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 without informed consent
6. Pregnant or possibly pregnant females
7. Patients with acute myocardial infarction, unstable angina, myocarditis, or cerebral infarction during the past 1 month
8. Patients with active infection including Treponema pallidum, or positive test for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
9. Patients with history of allergy for antibiotics
10. Patients with anemia or thrombocytopenia
11. Patients judged inappropriate for this study by phisician
12. Patients without agreement for including in this study
Target sample size
15
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
tminamino@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Ozawa |
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
takuya-o@med.niigata-u.ac.jp
Sponsor or person
Institute
BMI 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 Speci ally Certified Committee for Rege nerative Medicine
Address
3-1-1 Maidashi, Higashi-ku, Fuku oka, 812-8582, JAPAN
Tel
0926425082
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 | 10 | 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
0
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
no entry
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 | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 05 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 05 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 05 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 10 | Day |
Last modified on
| 2019 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024714
