Amyotrophic lateral sclerosis
Conditions
Interventions
Sponsors
Takeda Jun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A Takeda Hospital nervous physician and this therapy doctor in attendance do confirmation of the medical history and a medical examination to a subject of this research. The obstinacy which understands among the patient who fits in with the guideline check standard of table 1.2 and a gist of this research, and is scarce in the validity by the existence remedy which got consent by a document, I make a person with a disease (amyotrophic lateral sclerosis) the subject. I don't ask about the age and the gender. * The target disease patient performing an operation and treating it and for the purpose of checking it, who entered Kouseikai Takeda Hospital * The target disease patient going to foreignness of Kouseikai Takeda Hospital regularly * The patient who acquired agreement of test participation by one's own free will in a document
Exclusion criteria
Exclusion criteria: The patient who comes under the following standard excludes it from a target patient of this research. * The person who can't get the fat amount necessary to this research * Dialyzing patient * The patient who becomes pregnant * This research doctor in attendance is a subject, the patient who judged participation in this research was ethical and scientific and that improper from the angle of the safety * Patient who needs daidaku Next they're qualified from presences of the experience which confirmed the medical history put up as well as received blood transfusion or transplantation, it's done to judge. But, qualified, when judging, when becoming able to check it later about the medical history which couldn't be confirmed it'll be reconfirmed. (A) infection by the bacteria by which treponema pallidum is gonococci and tuberculosis bacilli, etc. (B) sapraemia and the question (C) malignant tumor (D) severe metabolism endocrine disease (E) severe haematological disorder (F) liver disease (G) communication, spongy encephalopathy and the question (H) family medical history which affects specific hereditary disorder and a disease concerned (I) pulmonary embolism shou
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and therapeutic effects of self-administered adipose tissue-derived mesenchymal stem cells cultured by Takara Bio Inc. were compared with before adipose tissue-derived mesenchymal stem cell administration, and evaluated 3 months after the last administration of cells, Changes in symptoms after the first dose are evaluated. In addition, follow-up is performed over time (one month, three months, six months, one year, two years, and three years after final administration). (Even if the study is discontinued during the first to third doses due to withdrawal of consent or for other reasons, the patient should be carefully monitored at the above intervals from the last dose of cultured cells.) Performed by inspection and specimen test. Rather than comparing the treatment group and the non-treatment group as in the clinical trial, the degree of symptom improvement in the same individual is compared with that before stem cell administration, and the change in symptoms over time is evaluated by this research doctor and neurologist . Amyotrophic lateral sclerosis (ALS): Changes in various symptoms (dysphagia, dysarthria, muscle weakness, etc.) are evaluated on the basis of before administration. (Document 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective symptoms | — |
Countries
Japan
Contacts
Public ContactTadayuki Nakayama
Takeda Hospital group head office
Outcome results
None listed