UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009943 |
|---|---|
| Receipt number | R000011647 |
| Scientific Title | Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2017/02/05 17:10:43 |
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Basic information
Public title
Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease
Acronym
Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease
Scientific Title
Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease
Scientific Title:Acronym
Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease
Region
| Japan |
Condition
Condition
Peripheral Arterial Disease (Fontaine stages three and four)
Classification by specialty
| Cardiology | Vascular surgery | Orthopedics |
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have reported that mesenhymal stem cells (MSC)could differentiate into vascular endothelial cells and produce vascular endothelial grows factor.The aim of this study is to investigate the efficacy and safety of culture expanded MSC for the treatments of peripheral artery disease. The MSC is derived from small amount(about 20ml) of patient's bone marrow cells and will be injected into the same patient's limb
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
ABI(Ankle Brechial Pressure Index): 7days, 1,6 and 12 months post transplantation.
Angiography : 12 months post transplantation.
Key secondary outcomes
Walking time without pain using tredmil: 1, 6 and 12 months post transplantation
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 |
Interventions/Control_1
Bone marrow of about 20ml is taken from the patient. The bone marrow is transferred to National Institute of Advanced Industrial Science and Technology (AIST) at Amagasaki city and cultured to expand the mesenchymal stem cell. The stem cell is transferred back to the hospital. Half ml of mesenchymal stem cells (2.5 x 106 cells/ml) is injected into ischemic area of lower extremity. The injection sites per extremity are about 40. When both extremities show ischemic change, more severe extremity is selected. If some clinical effect after the injection appear but not satisfactory, several repeated injection will be done, furthermore, if injection into other extremity is thought to be effective, another injection is done for this extremity. Total duration of the injection is within a half year after the first injection of the MSCs.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Peripheral Artery Disease: PAD
(2) Fontaine stages III and IV (ABI less than 0.6)
(3) The patient showing contraindications of angioplasty and bypass surgery due to spread areas of stricture or the stricture in small peripheral artery. Patients already treated with such angioplasty and bypass surgery, but showing the symptoms corresponding to above category (2).
(4) The patients by whom written consent is got from himself/herself by aged 20 and over (at the time of consent acquisition).
Key exclusion criteria
(1) The patient of hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) infection, and adult T-cell leukemia
(2) The hypersensitivity to a cow or pig origin protein, the patient that has the past of side effects
(3) The patient showing severe cardiac failure evidenced by cardiac echo examination.
(4) Malignant diseases.
(5) High-risk retinopathy
(6) Serious problems of liver and renal function
(7) Interstitial pneumonia.
(8) Blood diseases such as anemia and leykocytosis.
(9) A pregnant woman, a nursing mother, the patient that may have become pregnant, the female patient who is planning pregnancy by the end of this treatment term.
(10) In addition, the patient whom the principal investigator or the researcher judged to be unsuitable based on the medical rationale
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Ohgushi |
Organization
Ookuma Hospital
Division name
Department of Orthopedics
Zip code
Address
2-17-13 Kuise-honmachi, Amagasaki City, Hyogo 660-0814, JAPAN
TEL
06+64811667
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Narita |
Organization
Rogenkai Welfare Group
Division name
Headquarters
Zip code
Address
4-27-6 Higashi- sonoda -cho, Amagasaki, City, Hyogo 661-0953, JAPAN
TEL
06+64158590
Homepage URL
narita@ookuma.or.jp
Sponsor or person
Institute
Rogenkai Welfare Group
Institute
Department
Personal name
Funding Source
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Advanced Industrial Science and Technology (AIST)
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 12 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 03 | Day |
Last modified on
| 2017 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011647
