UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010143 |
|---|---|
| Receipt number | R000011825 |
| Scientific Title | Therapeutic Angiogenesis by autologous adipose-derived regenelative Cell Transplantation |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2022/03/07 09:07:58 |
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Basic information
Public title
Therapeutic Angiogenesis by autologous adipose-derived regenelative Cell Transplantation
Acronym
TACT-ADRCs
Scientific Title
Therapeutic Angiogenesis by autologous adipose-derived regenelative Cell Transplantation
Scientific Title:Acronym
TACT-ADRCs
Region
| Japan |
Condition
Condition
ASO, Buerger's disease, Collagen disease
Classification by specialty
| Cardiology | Clinical immunology | Vascular surgery |
| Dermatology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To treat patients with critical limb ischemia and to improve their QOL.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The safety of ADRCs transplantation.
2. Rescue rate of amputation.
Key secondary outcomes
1.Improvement rate of ischemic gangrene. 2.Improvement of QOL using Numerical Rating Scale (NRS)
3.ABI
4.SPP
5.Evaluation of angiogenesis by imaging
6.Walking distance in 6 minutes
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
| Device,equipment | Other |
Interventions/Control_1
The process is started with the harvest of a 300 mg of adipose tissue by standard manual liposuction under local anesthesia using a syringe and cannula. ADRCs are separated by the fully automated isolation using the Celution Systems. Isolated cells will be implanted into the ischemic skeletal muscles using a 23-gauge needle at 50 to 70 different points.
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
| 25 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Male and female, their age are more than 25 years old and less than 80 years old.
2.Symptoms include rest pain, with or without established ischemic ulcers. (Fontaine class III-IV)
A minimum of 4 weeks of conservative therapy without evidence of significant healing.
3.Patients accepted an informed consent.
Key exclusion criteria
1.Patient with insufficient amount of adipose tissue.
2.Patients does not accept an informed consent.
3.Any concomitant diseases with a life expectancy of <1 year.
4.Previous (within 5 years) or current history of neoplasm. Clinically significant abnormality in laboratory tests, including tumor markers.
5.Ischemic heart desease without revascularization.
6.Untreateed diabetic retinopathy.
7.Severe infection.
8.Severe Liver and/or renal dysfunction (except for patients under hemodialysis)
9.Severe hematopoietic disease
10.Pregnant
11.Patient whom physicians consider as inadequate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toyoaki |
| Middle name | |
| Last name | Murohara |
Organization
Nagoya University School of Medicine
Division name
Cardiology
Zip code
466-8550
Address
65 Tsurumai-machi, Showa-ku, Nagoya 466-8550 Japan
TEL
052-744-2149
murohara@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuuki |
| Middle name | |
| Last name | Shimizu |
Organization
Nagoya University School of Medicine
Division name
Cardiology
Zip code
466-8550
Address
65 Tsurumai-machi, Showa-ku, Nagoya 466-8550 Japan
TEL
052-744-2149
Homepage URL
shimi123@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Ethics Committee
Address
65 Tsurumai-machi, Showa-ku, Nagoya 466-8550 Japan
Tel
052-744-1901
ethics@med.nagoya-u.ac.jp
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
【臨床研究統括機関】名古屋大学医学部附属病院 循環器内科
【総括実施責任者】教授 室原豊明
【共同研究機関①】信州大学医学部附属病院 循環器内科
【実施責任者】教授 桑原宏一郎
【共同研究機関②】聖マリアンナ医科大学附属大学病院 循環器内科
【実施責任者】教授 明石嘉浩
【共同研究機関③】金沢大学附属病院 恒常性制御学講座
【実施責任者】教授 金子周一
【共同研究機関④】千葉大学医学部附属病院 循環器内科
【実施責任者】教授 小林欣夫
【共同研究機関⑤】医療法人徳洲会 福岡徳洲会病院 循環器内科
【実施責任者】副院長 下村英紀
【共同研究機関⑥】久留米大学医学部附属病院 心臓・血管内科
【実施責任者】主任教授 福本義弘
【共同研究機関⑦】獨協医科大学病院 心臓・血管内科
【実施責任者】教授 井上晃男
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
29
Results
We have performed implantation of autologous adipose-derived regenerative cells (ADRCs) into a PSS patient (64, female) on Sep. 13th 2013, a PSS + ASO patient (65, female)on Nov. 13th 2013, a TAO patient (49, male) on April 21st 2014, a overlap syndrome patient (28, female) on July 1st 2015, a SLE patient on Nov. 18th 2015 with CLI.
Six month after treatment, ischemic situations were clearly improved in all cases.
Since 2016, we have done this procedure for 29 more patients.
Results date posted
| 2019 | Year | 09 | Month | 18 | Day |
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
| 2012 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 11 | Month | 23 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 01 | Day |
Last modified on
| 2022 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011825
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