Unique ID issued by UMIN | UMIN000024133 |
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Receipt number | R000027322 |
Scientific Title | Clinical research (COPD) using autologous fat tissue from the mesenchymal stem cells |
Date of disclosure of the study information | 2016/09/22 |
Last modified on | 2018/09/23 16:50:02 |
Clinical research (COPD) using autologous fat tissue from the mesenchymal stem cells
Clinical research (COPD) using autologous fat tissue from the mesenchymal stem cells
Clinical research (COPD) using autologous fat tissue from the mesenchymal stem cells
Clinical research (COPD) using autologous fat tissue from the mesenchymal stem cells
Japan |
chronic obstructive pulmonary disease
Pneumology |
Others
NO
I lack in the effectiveness and am intended that I evaluate the improvement degree that compared the curative effect of the chronic obstructive pulmonary disease (COPD) 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
Safety,Efficacy
I evaluate the change of a symptom and the pulmonary function.Pulmonary function (the lung capacity, one second quantity), dyspnea (modified MRC), QOL, the hatred number of times, theweight, chest CT scanner, LAA %, nourishment evaluation
Interventional
expanded access
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Other |
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.
Not applicable |
Not applicable |
Male and Female
For the subject of this study, Takeda Hospital respiratory organs physician and this study medical attendant perform confirmation, the medical examination of the anamnesis. Among patients meeting COPD diagnosis and guidelines diagnostic criteria of the guidelines fourth edition from the fourth edition editing Japan respiratory organs society COPD guidelines making Committeefor treatment, the purpose of this study is understood and intends for the patient of the chronic obstructive pulmonary disease to have a poor intractable disease in the effectiveness by the existing cure that obtained its 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
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
6
1st name | |
Middle name | |
Last name | Jun Takeda |
Medical corporation foundation Kouseikai Takeda Hospital
the director of a hospital
841-5 Nishinotoin-dori Shiokoji-agaru Higashishiokoji-cho, Shimogyo Ward, Kyoto City
0753611351
J-takeda@takedahp.or.jp
1st name | |
Middle name | |
Last name | Tadayuki Nakayama |
Takeda Hospital group headquarters
Director of medical management
841-5 Nishinotoin-dori Shiokoji-agaru Higashishiokoji-cho, Shimogyo Ward, Kyoto City
0753611335
nakayama@takedahp.or.jp
Medical corporation foundation Kouseikai Takeda Hospital
Medical corporation foundation Kouseikai Takeda Hospital
Self funding
YES
PB5160010
Ministry of Health, Labour and Welfare
2016 | Year | 09 | Month | 22 | Day |
Unpublished
No longer recruiting
2016 | Year | 07 | Month | 15 | Day |
2016 | Year | 07 | Month | 29 | Day |
2016 | Year | 09 | Month | 22 | Day |
2018 | Year | 09 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027322
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