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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002612
Receipt No. R000003187
Scientific Title Implantation of autologous peripheral mononuclear cells for leg ulcer in patients with collagen diseases (phase I study)
Date of disclosure of the study information 2009/10/10
Last modified on 2012/04/20

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Basic information
Public title Implantation of autologous peripheral mononuclear cells for leg ulcer in patients with collagen diseases (phase I study)
Acronym Autologous peripheral mononuclear cells implantation for leg ulcer
Scientific Title Implantation of autologous peripheral mononuclear cells for leg ulcer in patients with collagen diseases (phase I study)
Scientific Title:Acronym Autologous peripheral mononuclear cells implantation for leg ulcer
Region
Japan

Condition
Condition leg ulcer with collagen diseases
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To find out the feasibility of implantation of autologous peripheral mononuclear cells for leg ulcer in patients with collagen diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Improvement of leg ulcer at 4 weeks following the implantation of autologous peripheral mononuclear cells
Key secondary outcomes 1.Safety
2.Size of leg ulcer
3.Presence of symptoms regarding to leg ulcer
4.Blood flow

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1.0x107 cells per administration
Interventions/Control_2 3.0x107 cells per administration
Interventions/Control_3 1.0x108 cells per administration
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients diagnosed as a collagen disease by the diagnostic criteria of each disease
2.Healthy volunteer who agreed to participate in writing
Key exclusion criteria 1.Patients not standing the risk of extracorporeal circulation
2.Women on (possible) pregnancy or lactation
3.Adolescents judged inadequate by doctor in charge of the patient or the study
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Tsutani
Organization National Hospital Organization Awara Hospital
Division name Department of Internal Medicine
Zip code
Address 238-1 Kitagata, Awara, Fukui 910-4272, Japan
TEL 0776-79-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tani Katsuya
Organization National Hospital Organization Awara Hospital
Division name Department of Pharmacy
Zip code
Address 238-1 Kitagata, Awara, Fukui 910-4272, Japan
TEL 0776-79-1211
Homepage URL http://www.hosp.go.jp/~awara/kenkyu.html
Email nhoawara-secretary@umin.ac.jp

Sponsor
Institute National Hospital Organization Awara Hospital
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 国立病院機構あわら病院(福井県)、国立病院機構金沢医療センター(石川県)、国立病院機構福井病院(福井県)、福井大学医学部付属病院(福井県)

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 10 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
2009 Year 09 Month 17 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 09 Day
Last modified on
2012 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003187

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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