Implantation of autologous peripheral mononuclear cells for leg ulcer in patients with collagen diseases (phase I study)
Phase 1
- Conditions
- leg ulcer with collagen diseases
- Registration Number
- JPRN-UMIN000002612
- Lead Sponsor
- ational Hospital Organization Awara Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients not standing the risk of extracorporeal circulation 2.Women on (possible) pregnancy or lactation 3.Adolescents judged inadequate by doctor in charge of the patient or the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of leg ulcer at 4 weeks following the implantation of autologous peripheral mononuclear cells
- Secondary Outcome Measures
Name Time Method 1.Safety 2.Size of leg ulcer 3.Presence of symptoms regarding to leg ulcer 4.Blood flow