Revasculization therapy with autologous peripheral blood mononuclear cells for the refractory skin ulcer in connective tissue disease and vasculitis.
- Conditions
- Skin ulcer in connective tissue disease and vasculitis.
- Registration Number
- JPRN-jRCTb070190060
- Lead Sponsor
- Hukushima Satoshi
- Brief Summary
Follow-up was completed for six patients who underwent mononuclear cell transplantation. However, this study was discontinued because the planned number of patients was not collected. Thus, sufficient data were not available for analysis of the primary and secondary endpoints. There was no adverse event due to this medical treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 6
1) Patients have the refractory skin ulcer resisntaice to normal therapy of connective tissue disease and vasculitis.
2) Duration time (more than 3 months) or significant quality of life disorders (amputation expected in future)
3) Age of consent acquisition date is 20 years or older
4) Patients who can give written voluntary informed consent (Proxies cannot give informed consent)
1) Patient with past severe allergy or adverse events of apheresis
2) Patient with current (or within the past 5 year) malignant tumor
3) Patient with acute myocardial infarction, unstable angina, myocarditis and cerebral infarction within 3 months
4) Patien with remarkable unstable circulation based on severe heart failure and arrhythmia.
5) Patient with active infection
6) Pregnant women or patients who may be pregnant
7) Patient with proliferative diabetic retinopathy (untreated or medium- and late-stage proliferative retinopathy); excludes patients who have completed treatment
8) Albumin less than 2g / dL
9) Patient judged to be inappropriate by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method