UMIN-CTR Clinical Trial

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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