UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002612 |
|---|---|
| Receipt number | 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 12:19:46 |
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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
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
nhoawara-secretary@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Awara Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003187
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
