A prospective, randomized study to assess the effect of autologous bone marrow-derived mononuclear cell therapy and its combination with percutaneous transluminal angioplasty (PTA) in comparison with repeated PTA in diabetic patients with peripheral arterial disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: In our study, the effect of autologous cell therapy (ACT) will be compared with repeated percutaneous transluminal angioplasty (re-PTA) in patients with diabetic foot and then will be compared the effect of combination treatment of ACT and re-PTA against re-PTA itself. We suppose an enhanced effect of this combination on on macro- and microcirculation. Expected results of the project include improved tissue oxygenation, enhanced DF healing and a reduced risk of major amputation.
Sponsor: Institut klinické a experimentální medicíny
Enrollment: 60
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

April 14, 2016

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•To include int the study the following criteria must be fullfilled:
•1\.diabetic foot disease (DFD; ulcer distal from ankle) or status after minor amputation, in accordance with international classification TEXAS 2C\-3D, Wagner 2\-4 or ischemic rest pain
•2\.presence of chronic critical limb ischemia attributable to objectively proven arterial occlusive disease (TcPO2\) under 40 mm Hg, indication for re\-PTA
•3\.age 18\-90 years
•4\.diabetes mellitus type 1 or 2
•5\.signed informed consent
•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 40

•Patients who fullfilled one of these criteria will be excluded:
•1\.severe active deep infection of DFD
•2\.deep vein thrombosis less than 6 months
•3\.severe limb oedema that rule out intramuscular injection of cell suspension
•4\.severe non\-treated diabetic retinopathy requiring acutely a laser therapy
•5\.severe haematological disease
•6\.diagnosed neoplastic process of any organ
•7\.expected life prognosis shorter than 6 months
•8\.contracindication of general anestesia
•9\.females of childbearing potential must be willing to use a highly effective method of contraception (hormonal or barrier method of birth control; abstinence). Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods.