UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010799 |
|---|---|
| Receipt number | R000012642 |
| Scientific Title | Hematopoietic stem cell transplantation for patients with ischemic limbs |
| Date of disclosure of the study information | 2013/05/24 |
| Last modified on | 2016/03/02 12:15:10 |
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Basic information
Public title
Hematopoietic stem cell transplantation for patients with ischemic limbs
Acronym
Therapeutic angiogenesis
Scientific Title
Hematopoietic stem cell transplantation for patients with ischemic limbs
Scientific Title:Acronym
Therapeutic angiogenesis
Region
| Japan |
Condition
Condition
Patients with intractable ulcers caused by collagen diseases
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness and tolerability of angiogenesis by autologous transplantation of bone marrow-derived cells in patients with ischemic limbs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of gangrene and reduction of ulcer size
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
| Maneuver |
Interventions/Control_1
Under general anesthesia, about 500-700 ml of bone marrow cells are collected from the ilium and mononuclear cells are separated on a centrifugal blood-cell separator. After separation, cells are concentrated by centrifugation. The cells are immediately implanted by intramuscular injection into an ischemic limb. In practice, we injected 0.5 ml of cells with
a 20-gauge needle 50 times at even intervals into an ischemic limb.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with collagen diseases are eligible
for the study if they have nonhealing ischemic ulcer caused by vasculopathy and their ulcers are resistant to conventional therapy.
Key exclusion criteria
We exclude patients with severe
involvement of the lung and heart.
We also exclude patients with active retinopathy due to diabetes mellitus, with evidence of malignant disorder during the past 5 years, or with history of cerebral stroke during the past a year. Patients with a history of alcohol and/or drug dependency during the past 3 months are also excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Ishigatsubo |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Internal Medicine and Clinical Immunology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2630
ishigats@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryusuke Yoshimi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Internal Medicine and Clinical Immunology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2630
Homepage URL
yoshiryu@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Internal Medicine and Clinical Immunology
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
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
| 2013 | Year | 05 | Month | 24 | 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
| 2013 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 24 | 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
| 2013 | Year | 05 | Month | 24 | Day |
Last modified on
| 2016 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012642
