Autologous cell therapy (ACT) is new technique for patients with critical limb ischemia and diabetic foot (DF). In our study, the effect of ACT and also the repetitive treatment will be compared with standard treatment in DF patients ineligible for angioplasty. We suppose an enhanced effect of ACT on on macro- and microcirculation and improved limb outflow. Expected results of the project include improved tissue oxygenation, enhanced DF healing and a reduced risk of major amputation. MedDRA ver
Conditions
Sponsors
Institut klinické a experimentální medicíny
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 2-3 (C-D), Wagner 2-4 2. presence of chronic critical limb ischemia – ulcers or gangrene attributable to objectively proven arterial occlusive disease (transcutaneous oxygen pressure TcPO2 under 35 mm Hg), non-eligibility for standard revascularization (PTA or by-pass) 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Safety: adverse events - expected and unexpected 2. Assesment of study treatment by patients (psychological questionaries) 3. To assess the relation between the quality of cell suspension and tissue oxygenation ;Timepoint(s) of evaluation of this end point: Safety: during and up to 6 months after the procedure Questionaries: after 1, 3 and 6 months after the procedure Quality: directly after the procedure | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the project is to compare the effect on tissue oxygenation and clinical outcome of autologous cell therapy with standard treatment in patients with diabetic foot disease (DFD) not eligible for PTA and to verify the effect of repetitive cell therapy. ;Secondary Objective: Other objectives of the project are quality of life assessment and side effects of study treatment. ;Primary end point(s): Comparison of cell therapy with standard treatment in several parameters: a)Assessment of tissue oxygenation – improvement of parameters of ischemia (measured by transcutaneous oxygen pressure andoptionally by other angiological methods) b)Clinical effect – wound healing, change in pain, rate of major amputation, amputation-free survival ;Timepoint(s) of evaluation of this end point: Transcutaneous oxygen pressure and other parameters will be assessed after 1, 3 and 6 months after the ACT. | — |
Countries
Czech Republic
Contacts
Public ContactDr. Michal Dubský
Institute for Clinical and Experimental Medicine
Outcome results
None listed