Comparison of the effect of autologous cell therapy with repeated angioplasty and assessment of the effect of combination of both methods on peripheral arterial disease in diabetic patients

Phase 1

• 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.; MedDRA version: 19.0Level: PTClassification code 10062585Term: Peripheral arterial occlusive diseaseSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-001398-34-CZ
• Lead Sponsor: Institut klinické a experimentální medicíny

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-14
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): 1.Comparison of both methods in several parameters:<br>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<br>b)Clinical effect – wound healing, pain, major amputation<br>;Timepoint(s) of evaluation of this end point: Transcutaneous oxygen pressure and other parameters will be assessed<br>after 1, 3 and 6 months after the ACT.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Safety: adverse events – expected and unexpected<br>2.Assesment of study treatment by patients (psychological questionaries)<br>;Timepoint(s) of evaluation of this end point: Safety: during and up to 6 months after the procedure<br>Questionaries: after 1, 3 and 6 months after the procedure