Therapeutic angiogenesis using bone marrow-derived mononuclear cells implantation for critical limb ischemiawith Buerger's disease - Therapeutic angiogenesis for critical limb ischemiawith Buerger's disease

Matoba Satoaki0 sites25 target enrollmentDecember 12, 2019

Overview

No summary available.

Registry

who.int

Start Date

December 12, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Matoba Satoaki

•Incorporate patients who satisfy 1\) to 6\).
•1\) Patients who are at least 20 years old and less than 80 years old at the time of obtaining written consent.
•2\) Sex does not matter.
•3\) Patients with obstructive thromboangiitis (Burger's disease) of Fontaine III\-IV.
•4\) Patients whose affected skin tissue perfusion pressure (SPP) at enrollment is less than 30 mmHg.
•5\) Patients who were confirmed to have no recovery after receiving the standard medical treatment listed. (Including patients who may have amputation of the affected limbs.) (\*) (\*) Standard treatment included in insurance means drug therapy such as blood flow improving drug and anti\-inflammatory analgesic, exercise therapy, sympathetic nerve It is a node block and revascularization such as percutaneous angioplasty and bypass surgery.
•6\) With regard to the benefits and disadvantages caused by receiving cell transplants, and the benefits and disadvantages resulting from not receiving cell transplants, the informed consent documents fully explain the patient's will Patients who have obtained written consent for study participation based on the need for understanding and consent of the family).

•1\) Diseases, even if the procedure is suitable, informed consent can not be obtained from the patient, or if it is difficult to adapt to the patient's family requiring emotional consideration.
•2\) Life expectancy is considered to be less than one year due to other complications.
•3\) When diagnosed as a malignant tumor.
•4\) If you have ischemic heart disease and revascularization has not been performed.
•5\) Untreated with severe diabetic retinopathy.
•6\) If you have a serious infection.
•7\) If there is severe liver dysfunction or renal dysfunction (except for maintenance dialysis patients).
•8\) If there is a serious blood disease such as leukopenia, thrombocytopenia and severe anemia requiring blood transfusion.
•9\) If pregnant and pregnant, or lactating women.
•10\) Those who participated in clinical trials or clinical trials such as medicines or medical devices at the same time as this study or within 30 days before being included in this study.