UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000200 |
|---|---|
| Receipt number | R000000274 |
| Scientific Title | Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for critical limb ischemia |
| Date of disclosure of the study information | 2005/09/13 |
| Last modified on | 2008/12/08 19:15:47 |
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Basic information
Public title
Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for critical limb ischemia
Acronym
Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for critical limb ischemia
Scientific Title
Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for critical limb ischemia
Scientific Title:Acronym
Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for critical limb ischemia
Region
| Japan |
Condition
Condition
Arteriosclerosis obliterance
Buerger's disease
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for the treatment of critical limb ischemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical findings
Symptoms
Ankle pressure index
Transcutaneous oximetry
Skin perfusion pressure
Air plethysmography
Angiography
Key secondary outcomes
Adverse events
Serum FGF2 concentration
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
Intra-arterial injection of acidic gelatin hydrogel microsphres (3mg)incorporating human recombinant fibroblast growth factor-2 (trafermin, 0.1mg)
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
| 35 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Arteriosclerosis obliterance or Buerger's disease
2. Fontaine III or Fontaine IV
3. Patients with no improvement by vascular reconstruction therapy and/or drug therapy
4. Written informed consent
Key exclusion criteria
1. Hypersensitivity for gelatin hydrogel
2. Serious medical co-morbidities
3. Alcoholism or other drug dependence within 3 months
4. Malignancy within 5 years
5. Possibility of malignancy
6. Operations within 3 months
7. Severe diabetic retinopathy
8. Pregnant woman, lactating woman
9. Vascular reconstruction within 2 months
10. Other complication unsuitable for the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Miyata |
Organization
The University of Tokyo Hospital
Division name
Department of Surgery, Division of Vascular Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-8411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Koyama |
Organization
The University of Tokyo Hospital
Division name
Department of Vascular Regeneration
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-8411
Homepage URL
http://plaza.umin.ac.jp/kekkan/
hkoyama-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Science, Sports and Culture
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The University of Tokyo, Division of Tissue Engineering
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
| 2005 | Year | 09 | Month | 13 | 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
Date of protocol fixation
| 2004 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 13 | Day |
Last modified on
| 2008 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000274
