UMIN-CTR Clinical Trial

Public title

Clinical research (ALS) using autologous fat tissue from the mesenchymal stem cells

Acronym

Clinical research (ALS) using autologous fat tissue from the mesenchymal stem cells

Scientific Title

Clinical research (ALS) using autologous fat tissue from the mesenchymal stem cells

Scientific Title:Acronym

Clinical research (ALS) using autologous fat tissue from the mesenchymal stem cells

Region

Japan

Condition

Amyotrophic lateral sclerosis

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

I lack in the effectiveness and am intended that I evaluate the improvement degree that compared the curative effect of the amyotrophic lateral sclerosis with the symptom before the mesenchyma system stem cell dosage derived from adipose tissue among the intractable diseases that other treatment means is not established by an existing cure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

I perform the evaluation by an examination for physical views and living body, a laboratory determination. I do not compare the administrated group, the non-administrated group like a clinical trial, and this study medical attendant and neurology medical attendant evaluate a symptom change at a symptom improvement degree in equivalence people over time in comparison with in front of stem cell dosage. I am based on before dosage and evaluate the change of various kinds of symptoms (including dysphagia, an articulation disorder, muscle weakness).

Key secondary outcomes

Study type

Interventional

Basic design

expanded access

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Transvenous in the self that obtained consent with a stem cell pro-mesenchyma derived from the self-adipose tissue which cultured in a Takeda Hospital intravenous feeding room; resemble it, and give 3 - 9 X 10^7 units three times (as a general rule two months distance) in total. But, as a result of culture of the mesenchyma system stem cell derived from 5.4 adipose tissue, I should be that I find a dosage cell for for once or the twice when it is lower than minimum cell count (9 X 10^7 unit) for three times of dosage. I examine the cell for the remaining dosage including the cause of the judgment of this study medical attendant, re-culture. In addition, as a result of culture of the mesenchyma system stem cell derived from adipose tissue, it shall be possible for the cause of the judgment of this study medical attendant, the cell dosage to be lower than minimum cell count (3 X 10^7 unit) for one time of dosage. But this case, this subject do not include it in the number of cases of this study and assume it a reference case. In addition, I shall ask the judgment of this study medical attendant when a confirmation matter occurs about the cell dosage. I observe the distance with enough stirring and an intravenous feeding set for blood transfusions in the cell dosage for 15 minutes in the dosage. I observe it after the dosage for one hour. Thereafter, I do it with the dosage at the interval as treatment for principle six months when the evaluation of the existence effect is provided, and there is hope of the additional treatment from a patient.

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

For the subject of this study, the Takeda Hospital neurologist and this medical treatment medical attendant performs confirmation, the medical examination of the anamnesis. Among patients meeting amyotrophy-related lateral sclerosis medical treatment guidelines diagnostic criteria, the purpose of this study is understood and intends for a patient of the amyotrophic lateral sclerosis to have a poor intractable disease in the effectiveness by the existing cure that obtained consent in a document. Age, the sex do not matter.
1 The target disease patient who was admitted to the Takeda Hospital in an operation and treatment, an inspection purpose
2 The target disease patient who visits a hospital for treatment in the outpatient department of the Takeda Hospital
3 The patient who acquired an agreement of this study entry by the free will of the person in a document

Key exclusion criteria

The patient corresponding to the following standards excludes it from a patient targeted for the final examination.
1 The person that quantity of fat necessary for this study is not provided
2 The patient whom I am dialyzing
3 Pregnant patient
4 This study medical attendant is the patient who ethical, it is scientific, and made a decision from the viewpoint of safety if the participation in this study is inappropriate of the subject
5 The patient who needs Agent approval
I confirm an anamnesis to advocate next and, from having experience or not that underwent a blood transfusion or transplant, do a competent thing judging. But I decide to reconfirm when I become able to confirm it about the anamnesis which I was not able to confirm at the time of a competent judgment later.
1 Infection with bacteria such as Treponema pallidum, a gonococcus, the tubercle bacillus
2 Sepsis and the doubt
3 Malignant tumor
4 Serious metabolism internal secretion disease
5 Serious blood disorder
6 Liver disease
7 Communicable spongy brain fever and the doubt
8 Family career to be concerned with a specific hereditary disease and the disease concerned
9 Pulmonary embolism

Target sample size

6

Name of lead principal investigator

1st name
Middle name
Last name	Jun Takeda

Organization

Medical corporation foundation Kouseikai Takeda Hospital

Division name

the director of a hospital

Zip code

Address

841-5 Nishinotoin-dori Shiokoji-agaru Higashishiokoji-cho, Shimogyo Ward, Kyoto City

TEL

0753611351

Email

J-takeda@takedahp.or.jp

Name of contact person

1st name
Middle name
Last name	Tadayuki Nakayama

Organization

Takeda Hospital group headquarters

Division name

Director of medical management

Zip code

Address

841-5 Nishinotoin-dori Shiokoji-agaru Higashishiokoji-cho, Shimogyo Ward, Kyoto City

TEL

0753611355

Homepage URL

Email

nakayama@takedahp.or.jp

Institute

Medical corporation foundation Kouseikai Takeda Hospital

Institute

Department

Personal name

Organization

Medical corporation foundation Kouseikai Takeda Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

PB5160011

Org. issuing International ID_1

Ministry of Health, Labour and Welfare

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人財団康生会武田病院(京都府)

Date of disclosure of the study information

2016

Year

09

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2016

Year

07

Month

15

Day

Date of IRB

Anticipated trial start date

2016

Year

07

Month

29

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

09

Month

22

Day

Last modified on

2018

Year

09

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027323