UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015017
Receipt number 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 10:40:42

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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 or person

Institute

Hematology Division, Internal Medicine, Hyogo college of Medicine

Institute

Department

Personal name



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

Value
https://center6.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