UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Regenerative cell therapy of ex vivo expanded autologous peripheral mononuclear cells for patients with non-healing wound -phase I study-
Title of the study (Brief title)	Regenerative cell therapy of ex vivo expanded autologous peripheral mononuclear cells for patients with non-healing wound -phase I study-
Region	Japan

Condition
Condition	non-healing wound
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For confirmation of safety of cell therapy of in vitro cultured autologous peripheral mononuclear cells for patients with non-healing wound after more than one month of conventional therapy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes	wound heling

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	Ex vivo expanded autologous peripheral mononuclear cells, 2 x 10^7 cells,within 20sites surround 20cm around the wound. subcutaneous or intramuscular injection
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1 Patients with severe wound more than Grade 1 of Wagner classification and our ulcer classification of Grade 3, who are resistant to the conventional therapy for more than a month and cannot expect improvement. 2 Patients who not improved wound with medical treatment for a month. 3 Patients are at the age of 20 to 75 at the time of informed consent
Key exclusion criteria	1 Patients showed more than 60% of wound recover by conventional therapy. 2 Patients with HbA1C more than 8.0% with the medication for diabetes. 3 Patients with total occlution of all major artery in hindlimb. 4 Patients with high cardiac hypofunction with ultrasonic cardiogram with left ventricle ejection fraction less than 25%. 5 Patients with the high coronary lesion which needs treatment. 6 Patients with malignant tumor and proliferative diabetic retinopathy .and other compliated malignat ischemic disease 7 Patients who cannot expect the remaining days more than one year for some kind of causes except the ischemia disease. 8 Patients with myocardial infarction or cerebral infarction onset within six months. 9 Patients with hematologic disorders such as leukemia, myeloproliferative disease, marrow dysplasia syndrome. 10 Patients with anemia (hemoglobin concentration less than 10.0 g/dL). 11 Patients with the severe respiratory functional disorder or impairment of liver function. 12 Pregnant women, lactating women, female patients who may be pregnant, and who plan the pregnancy by the end of the observation period. 13 Patients without informed consent. 14 Patients infected with HIV, HCV, HBV, HTLV or parvovirus B19. 15 Patients who are judged to be inappropriate to participate based on medical proof by a responsibile doctor or contributed doctors of this clinical study.
Target sample size	10

Research contact person
Name of lead principal investigator	Rica Tanaka
Organization	Juntendo University School of Medicine
Division name	Plastic and Reconstructive Surgery
Address	Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	rtanaka@juntenndo.ac.jp

Public contact
Name of contact person	Rica Tanaka
Organization	Juntendo University School of Medicine
Division name	Plastic and Reconstructive Surgery
Address	Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	rtanaka@juntenndo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and development, AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 03 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 06 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 28 Day
Last modified on	2018 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019241