Randomised clinical study of critical limb ischemia patients with foot ulcer and type II diabetes mellitus that will be treated with autologous bone marrow stemm cells derrived from iliac crest bone marrow aspirate and separated with SmartPReP2 separator with either intramuscular or intravenous aplication with monitoring major limb amputation prevention, metabolic and imunological parameters.
Phase 1
- Conditions
- o-option critical limb ischemia patients with T2DM and foot ulcersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-001825-28-CZ
- Lead Sponsor
- Fakultní nemocnice Ostrava,Czech Republic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s): ;Timepoint(s) of evaluation of this end point: 2years follow-up
- Secondary Outcome Measures
Name Time Method