| 基本情報/Basic information |
| 一般向け試験名/Public title |
ヒト自己脂肪組織由来間葉系幹細胞を用いた臨床研究(慢性閉塞性肺疾患) |
Clinical research (COPD) using autologous fat tissue from the mesenchymal stem cells
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| 一般向け試験名略称/Acronym |
ヒト自己脂肪組織由来間葉系幹細胞を用いた臨床研究(慢性閉塞性肺疾患) |
Clinical research (COPD) using autologous fat tissue from the mesenchymal stem cells |
| 科学的試験名/Scientific Title |
ヒト自己脂肪組織由来間葉系幹細胞を用いた臨床研究(慢性閉塞性肺疾患) |
Clinical research (COPD) using autologous fat tissue from the mesenchymal stem cells
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| 科学的試験名略称/Scientific Title:Acronym |
ヒト自己脂肪組織由来間葉系幹細胞を用いた臨床研究(慢性閉塞性肺疾患) |
Clinical research (COPD) using autologous fat tissue from the mesenchymal stem cells |
| 試験実施地域/Region |
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| 介入/Intervention |
| 群数/No. of arms |
1 |
| 介入の目的/Purpose of intervention |
診断/Diagnosis |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
培養した自己脂肪組織由来間葉系幹細胞を武田病院点滴室において、同意を得た自己に経静脈にて3～9×10^7 個を合計3回（原則として２ヶ月間隔）投与する。但し5.4 脂肪組織由来間葉系幹細胞の培養の結果、投与3回分の最低細胞数(9×10^7個)以下であった場合、1回分若しくは2回分の投与細胞を確保することを原則とする。残りの投与分の細胞については、本研究担当医の判断のもと、再培養を含め検討する。また、脂肪組織由来間葉系幹細胞の培養の結果、投与1回分の最低細胞数(3×10^7個)以下であった場合には、本研究担当医の判断のもと、細胞投与が出来るものとする。但しこの場合、本被験者は本研究の症例数には含めず、参考症例とする。その他、細胞投与について確認事項が発生した場合には、本研究担当医の判断を仰ぐものとする。細胞投与時には十分な攪拌と輸血用点滴セットを使用し、投与中15分間隔の観察をする。投与後は1時間観察を行う。それ以降、有効の評価が得られ、患者から追加治療の希望があった場合は、治療として原則６ヶ月間隔の投与とする。 |
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. |
| 介入2/Interventions/Control_2 |
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| 介入3/Interventions/Control_3 |
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| 介入6/Interventions/Control_6 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
本研究の被験者に対しては、武田病院呼吸器内科医及び本研究担当医が既往歴の確認・診察を行う。COPD(慢性閉塞性肺疾)診断と治療のためのガイドライン第4版(編集 日本呼吸器学会ＣＯＰＤガイドライン第4版作成委員会より)のガイドライン診断基準に適合する患者のうち、本研究の趣旨を理解され、文書で同意を得た既存治療法で有効性に乏しい難治性疾患を持つ人(慢性閉塞性肺疾患(COPD))を対象とする。年齢、性別は問わない。
1.武田病院に手術および治療、検査目的で入院した対象疾患患者
2.武田病院の外来に通院している対象疾患患者
3.本人の自由意思による本研究参加の同意を文書にて取得した患者 |
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
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| 除外基準/Key exclusion criteria |
以下の基準に該当する患者は本試験の対象患者から除外する。
1.本研究に必要な脂肪量が得られない者
2.透析中の患者
3.妊娠中の患者
4.本研究担当医師が，被験者の倫理的，科学的，安全性の観点から本研究への参加が不適切と判断した患者
5.代諾を必要とする患者
次に掲げる既往歴を確認するとともに、輸血又は移植を受けた経験の有無等から、適格性の判断を行うことする。ただし、適格性の判断時に確認できなかった既往歴について後日確認可能となった場合は、再確認することとする。
1.梅毒トレポネーマ、淋菌、結核菌等の細菌による感染症
2.敗血症及びその疑い
3.悪性腫瘍
4.重篤な代謝内分泌疾患
5.重篤な血液疾患
6.肝疾患
7.伝達性海綿状脳症及びその疑い
8.特定の遺伝性疾患及び当該疾患に係る家族歴
9.肺塞栓症
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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 |
| 目標参加者数/Target sample size |
6 |
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