UMIN-CTR Clinical Trial

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	2021 Year 05 Month 25 Day

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