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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010143
Receipt No. 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 2019/03/06

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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
Middle name
Last name Toyoaki Murohara
Organization Nagoya University School of Medicine
Division name Cardiology
Zip code
Address 65 Tsurumai-machi, Showa-ku, Nagoya 466-8550 Japan
TEL 052-744-2149
Email murohara@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuuki Shimizu
Organization Nagoya University School of Medicine
Division name Cardiology
Zip code
Address 65 Tsurumai-machi, Showa-ku, Nagoya 466-8550 Japan
TEL 052-744-2149
Homepage URL
Email shimi123@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University School of Medicine
Institute
Department

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
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 【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 池田宇一

【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
Results
On Sep. 13th 2013, we have performed implantation of autologous adipose-derived regenerative cells (ADRCs) into a PSS patient (64, female) with Fontaine IV. Six month after treatment, we found a development of collateral vessels, a reduction of ulcer size and a decrease of the frequency of rest pain.
On Nov. 13th 2013, we have implanted autologous ADRCs into the ischemic leg of PSS + ASO patient (65, female). Six month after treatment, ischemic situation was clearly improved.
On April 21st 2014, we have implanted ADRCs into the ischemic leg of TAO patient (49, male). Six month after implantation, his ischemic ulcer is curable by cell therapy.
On July 1st 2015, we have done the implantation of ADRCs for the patient with hand ulcers due to overlap syndrome.Six month after treatment, we found a decrease of the frequency of rest pain and her ischemic ulcer is cured. 
On November 18th 2015, we have done the implantation of ADRCs for the patient with ischemic foot ulcers due to SLE.
Since 2016, we have done this procedure for 21 more patients.
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 Open public recruiting
Date of protocol fixation
2012 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 01 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011825

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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