Therapeutic angiogenesis using bone marro w-derived mononuclear cells implantation for critical limb ischemia (Therapeutic angiogenesis for critical limb ischemia)
- Conditions
- critical limb ischemia (arteriosclerosis obliterans, Buerger's disease, collagen disease vasculitis)critical limb ischemia, Buerger'a disease
- Registration Number
- JPRN-jRCTb050190123
- Lead Sponsor
- Matoba Satoaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
We enroll patients included all of the inclusion criteria.
1) Patients who are over 20 years old and under 80 years old when obtaining written consent.
2) Any gender is acceptable.
3) Fontaine III-severe severe ischemic limb (occlusive arteriosclerosis, Buerger's disease, vasculitis due to collagen disease).
4) Patients who have been confirmed that there is no recovery after applying the standard treatment listed in the insurance, or who are judged to have no indication for revascularization by vascular surgeons and cardiologists, and who will be forced to have amputation in the future. (Includes patients with the possibility of small amputation.) (*)
5) Regarding the benefits / disadvantages arising from receiving a cell transplant and the benefits / disadvantages arising from not receiving a cell transplant, the patient's will and / or family's understanding and consent will be fully explained in the consent explanation document. Patients who have obtained written consent to participate in the study.
(*) Standard treatment listed in insurance '' refers to drug therapy such as blood flow improving drugs and anti-inflammatory analgesics, exercise therapy, sympathetic ganglion block, and revascularization such as percutaneous angioplasty and bypass.
1) Even if the disease and the surgical procedure are appropriate, informed consent cannot be obtained from the patient, or emotional consideration is required for the patient's family and it is difficult to adapt.
2) Life expectancy is less than one year due to other complications.
3) When a malignant tumor is diagnosed.
4) If you have ischemic heart disease and have not been revascularized.
5) If you have severe diabetic retinopathy and have not been treated.
6) If you have a serious infection.
7) When severe liver dysfunction or renal dysfunction (excluding maintenance dialysis patients) exists.
8) When there are severe blood disorders such as leucopenia and thrombocytopenia and severe anemia requiring blood transfusion.
9) Pregnant and possibly pregnant or breastfeeding.
10) Those who participated in clinical trials or clinical trials for pharmaceuticals or medical devices at the same time as this trial or within 30 days before enrollment in this trial.
11) Other serious acute / chronic medical / mental conditions or laboratory abnormalities that may increase the risk of study participation or may affect the interpretation of study results .
12) In addition, when the person in charge of the implementation or the investigator determines that it is inappropriate to participate in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from 6 months after transplantation to registration of affected numerical rating scale
- Secondary Outcome Measures
Name Time Method 1. Changes from the time of registration of ABI <br>2. Six minutes walking distance<br>3. Evaluation of ischemic ulcer by visual inspection