UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000404 |
|---|---|
| Receipt number | 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 03:15:01 |
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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
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/
takum@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000493
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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