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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015017
Receipt No. R000017416
Scientific Title Amniotic membrane-derived mesenchymal stromal cells for the treatment of steroid-resistant acute GVHD
Date of disclosure of the study information 2014/09/08
Last modified on 2019/03/07

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Basic information
Public title Amniotic membrane-derived mesenchymal stromal cells for the treatment of
steroid-resistant acute GVHD
Acronym Amnion MSC for GVHD
Scientific Title Amniotic membrane-derived mesenchymal stromal cells for the treatment of
steroid-resistant acute GVHD
Scientific Title:Acronym Amnion MSC for GVHD
Region
Japan

Condition
Condition steroid resistant GVHD
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Allogeneic hematopoietic stem cell transplantation is the curative therapeutic option for hematopoietic malignancies and insufficiencies. Although there has been nearly 40 years of clinical experience in treatment of graft versus host disease (GVHD) as a major burden following allogeneic hematopoietic stem cell transplantation, it remains to be improved. Various immunosuppression agents have been developed for clinical use. The number of immunosuppression agents that can suppress the natural immune system, which is thought to be a trigger of GVHD onset, remains small. Recent studies have shown that mesenchymal stem cells (MSC) are present in various types of tissue, and a strong modulator of both acquired and natural immune systems. Thus, MSC may show promise for the treatment of excess immune responses. Amniotic membrane derived MSCs can be an alternative MSC source. Fetal accessory tissue derived cells are the youngest cells that can be obtained clinically. They are minimally affected by environment and life history, have active proliferative activity ready for expansion, and have stable quality. The steroid resistant GVHD, which was selected as the target for treatment this time, has a refractory nature, and the mortality rate of severe cases remains quite high. Thus, development of new therapeutic agents is desired.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Safety of up to 52 weeks after
Key secondary outcomes CR to be continued 4 weeks or more
CR/PR at the time of 4weeks after the first dose

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 infusion of Amnion derived MSC
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
15 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Steroid Resistant GVHD grade II or over
Steroid Resistant GVHD grade I or over with high risk transplantation for GVHD e.g. GVHD in HLA Haploidentical Transplantation
Key exclusion criteria 1 patients with Liver damage other than GVHD (Total bililubin >2.0mg/dl or AST and/or ALT>200U/L
2 patients with Serum creatinine >2mg/dl
3 patients with allergy to bovine or porcine products
4 patienst with relapsed at MSC infusion
5 patients with uncontrolled infection
6 blood O2 saturation <94% even 3L/min Oxygen supply
7 Patients attending physician has determined ineligible.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Ogawa
Organization Hyogo College of Medicine
Division name Hematology
Zip code
Address 1-1 mukogawa-cho, Nishinomiya, Hyogo,Japan
TEL +81-798-45-6886
Email ogawah@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Soma
Organization Hyogo college of Medicine
Division name Hematology
Zip code
Address 1-1 mukogawa-cho, Nishinomiya, Hyogo,Japan
TEL +81-798-45-6886
Homepage URL
Email somat@hyo-med.ac.jp

Sponsor
Institute Hematology Division, Internal Medicine, Hyogo college of Medicine
Institute
Department

Funding Source
Organization Japanese Government
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National cereberal and cardiovascukar Center
Faundation for biomedical Research and innovation
Hokkaido Graduate school of medicine
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 兵庫医科大学病院
The Hospital of Hyogo College of Medicine

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Terminated
Date of protocol fixation
2014 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 16 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
2014 Year 09 Month 02 Day
Last modified on
2019 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017416

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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