E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
Autologous cell therapy of critical limb ischemia and diabetic foot will be compared with repeated angioplasty by means of - tissue oxygenation, major amputation and wound healing. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062585 |
E.1.2 | Term | Peripheral arterial occlusive disease |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim of the project is to compare the effect on tissue oxygenation and clinical outcome of autologous cell therapy with repeated PTA (re-PTA) in patients with diabetic foot disease (DFD) indicated for re-PTA. |
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E.2.2 | Secondary objectives of the trial |
Other objective is to compare the effect of combination treatment of cell therapy and re-PTA with re-PTA itself and to assess potential side effects of both methods. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Comparison of both methods in several parameters:
a) Assessment of tissue oxygenation – improvement of parameters of ischemia (measured by transcutaneous oxygen pressure) after injection of tested suspension in both BMMNC isolation methods in comparsion with baseline and after 3 months
b) Clinical effect – wound healing, pain, major amputation
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E.5.1.1 | 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. |
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E.5.2 | Secondary end point(s) |
1. Safety: adverse events – expected and unexpected
2. Assesment of study treatment by patients (psychological questionaries)
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
repeated percutaneous transluminal angioplasty |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Poslední návštěva posledního pacienta |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |