UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000845
Receipt number R000001006
Scientific Title Intra-arterial injection of donor mesenchymal stromal cells for treating refractory acute Graft-vs-Host disease after hemopoietic stem cell transplantation
Date of disclosure of the study information 2007/10/07
Last modified on 2008/12/09 10:03:28

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Basic information

Public title

Intra-arterial injection of donor mesenchymal stromal cells for treating refractory acute Graft-vs-Host disease after hemopoietic stem cell transplantation

Acronym

Intra-arterial injection of donor mesenchymal stromal cells for treating refractory acute GVHD

Scientific Title

Intra-arterial injection of donor mesenchymal stromal cells for treating refractory acute Graft-vs-Host disease after hemopoietic stem cell transplantation

Scientific Title:Acronym

Intra-arterial injection of donor mesenchymal stromal cells for treating refractory acute GVHD

Region

Japan


Condition

Condition

refractory acute GVHD

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate safety and efficacy of intra-arterial injection therapy of donor-derived mesenchymal stromal cells for refractory acute GVHD

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Clinical response at 2 weeks after MSC therapy

Key secondary outcomes

Clinical response at 4 weeks after MSC therapy
Overall survival at 4 weeks after MSC therapy


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Intra-arterial administration of donor-derived mesenchymal stromal 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



Eligibility

Age-lower limit

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Diagnosed as steroid-refractory acute GVHD in gut or liver
2. No steroid-pulse therapy or ATG therapy within 2 weeks
3. No biological response modifier such as IL-2, IFN, ubenimex within 2 weeks
4. Getting into remission of malignancy
5. no severe or uncontollable infection
6. Meet the following criteria for organ functions
(1)Serum AST/GOT or ALT/GPT less than 30 folds of upper normal limit
(2)Serum creatinin clearance more than 20ml/min
(3)Ejection fraction of cardiac left ventricle more than 50% by ultrasonography
(4)Arterial oxygen pressure more than 60 mmHg
(5)Arterial bicarbonate pressure less than 60 mmHg"

Key exclusion criteria

1.Positive for HIV Ab
2.Uncontrollable infection such as mucor, EBV-LPD, Gancyclovir-refractory CMV, measles.
3.severe psychiatric disorder

Target sample size

8


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuyoshi Arima

Organization

The Tazuke Kofukai Medical Research Institute Kitano Hospital

Division name

Department of Hematology

Zip code


Address

2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Nobuyoshi Arima

Organization

The Tazuke Kofukai Medical Research Institute Kitano Hospital

Division name

Department of Hematology

Zip code


Address

2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN

TEL


Homepage URL


Email

n-arima@kitano-ho.or.jp


Sponsor or person

Institute

Department of Hematology, The Tazuke Kofukai Medical Research Institute Kitano Hospital

Institute

Department

Personal name



Funding Source

Organization

CHUGAI PHARMACEUTICAL

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Institute of Advanced Industrial Science and Technology, Research Institute for Cell Engineering

Name of secondary funder(s)

Kirin Pharma Company, Limited


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

2007 Year 10 Month 07 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Enrolled case:3
Bone marrow collection & MSC culture:3
Culture using with FCS:0
MSC administration:3(intra-arterial)
Early side effects:0

CR:0
PR:1
NC:1
PD:1

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

2006 Year 01 Month 27 Day

Date of IRB


Anticipated trial start date

2006 Year 04 Month 01 Day

Last follow-up date

2008 Year 08 Month 01 Day

Date of closure to data entry

2008 Year 08 Month 01 Day

Date trial data considered complete

2008 Year 08 Month 01 Day

Date analysis concluded

2008 Year 11 Month 01 Day


Other

Other related information

Idiopathic pneumonia syndrome developed in two of three cases(Day19,Day160)


Management information

Registered date

2007 Year 10 Month 07 Day

Last modified on

2008 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001006


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name