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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000404
Receipt No. R000000493
Scientific Title Phase I and IIa, Dose Escalation, Non-Randomized, Safety and Efficacy Evaluation Clinical Study for Angiogenic Gene Therapy to Treat Patients with Critical Limb Ischemia via Intramuscular Injection of Non-Transmissible Recombinant Sendai Virus Expressing Human Fibroblast Growth Factor-2 (FGF-2) Gene.
Date of disclosure of the study information 2006/04/20
Last modified on 2013/04/24

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Basic information
Public title Phase I and IIa, Dose Escalation, Non-Randomized, Safety and Efficacy Evaluation Clinical Study for Angiogenic Gene Therapy to Treat Patients with Critical Limb Ischemia via Intramuscular Injection of Non-Transmissible Recombinant Sendai Virus Expressing Human Fibroblast Growth Factor-2 (FGF-2) Gene.
Acronym Phase I and IIa clinical study to treat clitical limb ischemia using SeV/dF-hFGF2
Scientific Title Phase I and IIa, Dose Escalation, Non-Randomized, Safety and Efficacy Evaluation Clinical Study for Angiogenic Gene Therapy to Treat Patients with Critical Limb Ischemia via Intramuscular Injection of Non-Transmissible Recombinant Sendai Virus Expressing Human Fibroblast Growth Factor-2 (FGF-2) Gene.
Scientific Title:Acronym Phase I and IIa clinical study to treat clitical limb ischemia using SeV/dF-hFGF2
Region
Japan

Condition
Condition Critical limb ischemia (CLI) due to arteriosclerosis obliterans or thromboangitis obliterans (Buerger's disease)
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the overall safety of intramuscular administration of SeV/dF-hFGF2 in the CLI subject.
Basic objectives2 Others
Basic objectives -Others To evaluate the potential and dose-dependent therapeutic effect due to angiogenesis induced by SeV/dF-hFGF2.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes 1. Physical examination
2. Blood and urine analyses
3. ECG
4. Vital signs
5. Adverse events
6. Viral shedding
Key secondary outcomes 1. Improvement of wound healing
2. Reduction of amputation
3. Improvement of rest pain
4. Improvement of hemodynamic measurement

Base
Study type Interventional

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

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Gene
Interventions/Control_1 DVC-0101: 5x10e7 ciu/60 kg
Interventions/Control_2 DVC-0101: 2x10e8 ciu/60 kg
Interventions/Control_3 DVC-0101: 1x10e9 ciu/60 kg
Interventions/Control_4 DVC-0101: 5x10e9 ciu/60 kg
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects will have one or more clinical indications diagnostic of CLI due to arteriosclerosis obliterans or thromboangitis obliterans such as: 1) distal extremity pain at rest that requires the subject to use analgesics for >2 weeks (Fontaine grade III); or peripheral ischemic ulcer(s); or areas of gangrene (Fontaine grade IV, exclude Rutherford grade III, group 6).
1. The subject is a poor candidate for standard revascularization treatment options for
peripheral arterial disease, based on inadequate bypass conduit, unfavorable anatomy, or
poor operative risk.
2. Subjects will be without any effect of anti-platelet and/or vasodilator agents for at least 2 weeks prior to treatment.
3. 40 Years and above.
Key exclusion criteria 1. Subjected with severe allergy or its history.
2. Suspected malignant neoplasm (clinical, laboratory or imaging).
3. Subjects who have proliferative diabetic retinopathy or severe, non-proliferative
retinopathy.
4. Subjects receiving chronic hemodialysis therapy.
5. Subjects who have severe heart dysfunction or faiure.
6. Subject who have hepatic dysfunction or cirrhosis.
7. Subjects with end stage renal disease (ESRD).
8. Subject who have active inflammatory diseases.
9. Subject who have recieved operative resection of malignant neoplasm 5 years prior to treatment.
10. Subjects who have experienced celebral hemorrhage or infarction 6 months prior to treatment.
11. Subjects with hematopoietic disorders.
12. Alcoholism and/or drug dependence.
13. Female subjects with pregnant or doubt of pregnacy.
14. Othors
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Maehara MD PhD FACS
Organization Kyushu University Hospital
Division name Department of Surgery and Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5466
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Onohara/ Takuya Matsumoto
Organization Kyushu University Graduate School of Medical Sciences
Division name Department of Surgery and Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5466
Homepage URL http://www.gt.med.kyushu-u.ac.jp/
Email takum@surg2.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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 九州大学病院

Other administrative information
Date of disclosure of the study information
2006 Year 04 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
To the best of our knowledge, this is the first clinical trial of the use of a gene transfer vector based on rSeV. The single intramuscular administration of DVC1-0101 to PAD patients was safe and well tolerated, and resulted in significant improvements of limb function. Larger pivotal studies are warranted as a next step.
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
2006 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2009 Year 03 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 The result of the current study has been published on Molecular Therapy.

DVC1-0101 to Treat Peripheral Arterial Disease: A Phase I/IIa Open-label Dose-escalation Clinical Trial

Mol Ther 21: 707-714, 2013.

Yoshikazu Yonemitsu, Takuya Matsumoto, Hiroyuki Itoh, Jin Okazaki, Makiko Uchiyama, Kumi Yoshida, Mitsuho Onimaru, Toshihiro Onohara, Hiroyuki Inoguchi, Ryoichi Kyuragi, Mototsugu Shimokawa, Hiroshi Ban, Michiko Tanaka, Makoto Inoue, Tsugumine Shu, Mamoru Hasegawa, Yoichi Nakanishi and Yoshihiko Maehara

http://www.nature.com/mt/journal/v21/n3/full/mt2012279a.html

Management information
Registered date
2006 Year 04 Month 12 Day
Last modified on
2013 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000493

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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