UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007316 |
|---|---|
| Receipt number | 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 | 2021/05/25 15:53:44 |
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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
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
tmizushima@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005931
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
