UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical research (ALS) using autologous fat tissue from the mesenchymal stem cells
Title of the study (Brief title)	Clinical research (ALS) using autologous fat tissue from the mesenchymal stem cells
Region	Japan

Condition
Condition	Amyotrophic lateral sclerosis
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	expanded access
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	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

Eligibility
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

Research contact person
Name of lead principal investigator	Jun Takeda
Organization	Medical corporation foundation Kouseikai Takeda Hospital
Division name	the director of a hospital
Address	841-5 Nishinotoin-dori Shiokoji-agaru Higashishiokoji-cho, Shimogyo Ward, Kyoto City
TEL	0753611351
Email	J-takeda@takedahp.or.jp

Public contact
Name of contact person	Tadayuki Nakayama
Organization	Takeda Hospital group headquarters
Division name	Director of medical management
Address	841-5 Nishinotoin-dori Shiokoji-agaru Higashishiokoji-cho, Shimogyo Ward, Kyoto City
TEL	0753611355
Homepage URL
Email	nakayama@takedahp.or.jp

Sponsor
Institute	Medical corporation foundation Kouseikai Takeda Hospital
Institute
Department

Funding Source
Organization	Medical corporation foundation Kouseikai Takeda Hospital
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	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
Institutions	医療法人財団康生会武田病院(京都府)

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 23 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 07 Month 15 Day
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

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Publication of results	Unpublished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

Management information
Registered date	2016 Year 09 Month 22 Day
Last modified on	2018 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027323