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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000200
Receipt No. 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

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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
Email

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/
Email hkoyama-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000274

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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