UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031645 |
|---|---|
| Receipt number | R000036129 |
| Scientific Title | Clinical trial related with transplantation therapy with human autologous cell mixed sheets for refractory cutaneous ulcer |
| Date of disclosure of the study information | 2018/03/09 |
| Last modified on | 2021/03/11 10:39:25 |
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Basic information
Public title
Clinical trial related with transplantation therapy with human autologous cell mixed sheets for refractory cutaneous ulcer
Acronym
Autologous cell mixed sheets transplantation for refractory cutaneous ulcer
Scientific Title
Clinical trial related with transplantation therapy with human autologous cell mixed sheets for refractory cutaneous ulcer
Scientific Title:Acronym
Autologous cell mixed sheets transplantation for refractory cutaneous ulcer
Region
| Japan |
Condition
Condition
refractory cutaneous ulcer
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify safety of transplantation therapy with human autologous cell mixed cell sheet which consist of fibroblasts and peripheral blood mononuclear cells for patients with refractory cutaneous ulcer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence, frequency, and severity of all adverse events
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
Therapeutic angiogenesis using autologous bone marrow mononuclear cell
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients not adequate for conventional therapy.
2. Patients with wound area of cutaneous ulcers which is covered with cell sheets enough.
3. Patients can provide written informed consent for study participation.
4. Patients with venous reflux detected by air plethysmography or ultrasound.
Key exclusion criteria
1. Patients suffering from critical limb ischemia.
2. Patients suffering from malignant neoplasm.
3. Patients suffering from bacterial infections such as treponema palladium, chlamydia, gonorrhea and tuberculosis.
4. Patients suffering from infections such as hepatitis B and C viruses, human immunodeficiency virus, human T lymphotropic virus type 1 and parvovirus B19.
5. Patients with allergy of local anesthesia.
6. Hemoglobin: < 8.0 g/dL, Plt: < 50,000 /uL, Prothrombin time: < 40%
7. Patients with sepsis or suspected with.
8. Patients with congenital coagulopathy, antiplatelet drug use, or anticoagulant use.
9. Patients who have experienced other cell or gene therapy
10. Patients who join other clinical trials or joined them within 6 months.
11. Patients with hemodialysis.
12. Patients who developed unstable angina, myocardial ischemia, or cerebral infarction within 3 months
13. Pregnant woman and women who may possibly be pregnant, women in nursing
14. Patients with allergy of aminoglycoside antibiotics.
15. Patient determined to be ineligible for this clinical study by research attending physician.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Hamano |
| Middle name | |
| Last name | Kimikazu |
Organization
Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Division name
Division of first surgery
Zip code
755-8505
Address
Ube, 755-8505, Japan
TEL
0836-22-2261
tmizo@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Mizoguchi |
Organization
Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Division name
Division of first surgery
Zip code
755-8505
Address
Ube, 755-8505, Japan
TEL
0836-22-2261
Homepage URL
tmizo@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamaguchi university clinical research center
Address
Ube, 755-8505, Japan
Tel
0836-22-2428
me223@yamaguchi-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
| 2018 | Year | 03 | Month | 09 | 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
6
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
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 09 | Day |
Last modified on
| 2021 | 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=R000036129
