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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007316
Receipt No. R000005931
Scientific Title Clinical Trial of the Treatment for Fistula after Gastrointestinal Surgery by Adipose Derived Regenerative Cell Transplantation
Date of disclosure of the study information 2012/03/01
Last modified on 2016/07/06

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Basic information
Public title Clinical Trial of the Treatment for Fistula after Gastrointestinal Surgery by Adipose Derived Regenerative Cell Transplantation
Acronym Clinical Trial of the Treatment for Fistula after Gastrointestinal Surgery by Adipose Derived Regenerative Cell Transplantation
Scientific Title Clinical Trial of the Treatment for Fistula after Gastrointestinal Surgery by Adipose Derived Regenerative Cell Transplantation
Scientific Title:Acronym Clinical Trial of the Treatment for Fistula after Gastrointestinal Surgery by Adipose Derived Regenerative Cell Transplantation
Region
Japan

Condition
Condition Fistula caused by infectious complications after Gastrointestinal Surgery
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility and safety of adipose derived regenerative cell transplantation in the treatment of fistulas after gastrointestinal surgery
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency, type, severity, and duration of adverse events
Key secondary outcomes

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
Other
Interventions/Control_1 Adipose Derived Regenerative Cell
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patient with fistula after gastrointestinal surgery refractory to conventional therapy at least one month
2)Measurable Fistula by CT, MRI, radiologic contrast study and/or endoscopy
3)fistula volume 10ml
4)Age 20-75 years and less
5)Body weight 40kg and more
6)Normal cardiac function
7)The Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 to 1
8)Vital organ functions listed below are preserved prior to entry
1. WBC 4,000 /mm3 and over
2. Hemoglobin 9.0 g/dl and over
3. Platelet 100,000 /mm3 and over
4. Total bilirubin 1.5 ml/dl and less
5. AST and ALT 100 IU/l and less
6. Creatinine 1.5 mg/dl and less
9)Written informed consent
Key exclusion criteria 1)Patients with cancer
2)Any anti-cancer therapy
3)Gastrointestinal obstruction
4)Active infection
5)Serious comorbid disease (such as cardiovascular , pulmonary, liver, renal, hemorrhagic diesases, uncontrollable diabetes mellitus or hypertension)
6)Anticoagulation or antiplatelets therapy
7)History of prior drug allergy
8)Pregnant women, possibly pregnant women, and nursing mothers
9)Other conditions not suitable for this study
Target sample size 7

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Mori
Organization Osaka University Graduate School of Medicine
Division name Department of Surgery
Zip code
Address 2-2 Yamadaoka Suita City Osaka
TEL 06-6879-3251
Email mmori@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsunekazu Mizushima
Organization Osaka University Graduate School of Medicine
Division name Department of Surgery
Zip code
Address 2-2 Yamadaoka Suita City Osaka
TEL 06-6879-3251
Homepage URL
Email tmizushima@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://link.springer.com/article/10.1007%2Fs00595-015-1246-8
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 Completed
Date of protocol fixation
2011 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 10 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
2012 Year 02 Month 17 Day
Last modified on
2016 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005931

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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