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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031645
Receipt No. 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 2018/03/09

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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
Middle name
Last name Kimikazu Hamano
Organization Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Division name Division of first surgery
Zip code
Address Ube, 755-8505, Japan
TEL 0836-22-2261
Email tmizo@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Mizoguchi
Organization Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Division name Division of first surgery
Zip code
Address Ube, 755-8505, Japan
TEL 0836-22-2261
Homepage URL
Email tmizo@yamaguchi-u.ac.jp

Sponsor
Institute Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Institute
Department

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
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

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
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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 05 Day
Last follow-up date
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
2018 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036129

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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