UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of mesenchymal stem cells for treatment of refractory acute GVHD after stem cell transplantation
Title of the study (Brief title)	Efficacy of mesenchymal stem cells for treatment of refractory acute GVHD
Region	Japan

Condition
Condition	refractoty acute GVHD after stem cell transplantation
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of mesenchymal stem cells for treatment of refractory acute GVHD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	GVHD score
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Medicine
Interventions/Control_1	Intravenous injection of mesenchymal stem cells
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) after stem cell transplantation 2) acute GVHD (grade III-IV) 3) refractory or relapsed acute GVHD after steroid therapy 4) written informed consent 5) HLA matched or one locus mismatched donor
Key exclusion criteria	1) in relapse disease status 2) in unconsciousness 3) in severe infection
Target sample size	5

Research contact person
Name of lead principal investigator	Keiya Ozawa
Organization	Jichi Medical University
Division name	Division of Hematology
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi
TEL	0285-58-7353
Email

Public contact
Name of contact person	Kazuya Sato
Organization	Jichi Medical University
Division name	Division of Hematology
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi
TEL	0285-58-7353
Homepage URL
Email	kazuya@jichi.ac.jp

Sponsor
Institute	Jichi Medical University, Department of Medicine, Division of Hematology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Jichi Medical University, Department of Medicine, Division of Hematology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2006 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 01 Month 16 Day
Anticipated trial start date	2006 Year 06 Month 01 Day
Last follow-up date	2009 Year 05 Month 01 Day
Date of closure to data entry	2009 Year 06 Month 01 Day
Date trial data considered complete	2009 Year 07 Month 01 Day
Date analysis concluded	2009 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2006 Year 05 Month 29 Day
Last modified on	2016 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000507