Autologous bone marrow-derived mononuclear cells for Diabetic foot ulcer | Chronic limb-threatening ischemia | Diabetes mellitus (type 1 or 2)

Inclusion criteria

• {"criterion_text":"- diabetic foot ulcers (DFU; ulcer distal from ankle) or status after minor amputation, in accordance with international classification TEXAS 2C-3D, Wagner 2-4 or ischemic rest pain\n- presence of chronic limb-threatening ischemia attributable to objectively proven arterial occlusive disease; (TcPO2) under 40 mm Hg, indication for PTA\n- age 18-90 years\n- diabetes mellitus type 1 or 2\n- signed informed consent"}

Exclusion criteria

• {"criterion_text":"- severe active deep infection of DFU\n- pregnant women – the test of pregnancy is the part of the examination before inclusion into the study\n- deep vein thrombosis less than 6 months\n- severe limb oedema that rule out intramuscular injection of cell suspension\n- severe non-treated diabetic retinopathy requiring acutely a laser therapy\n- severe haematological disease\n- diagnosed neoplastic process of any organ less than 5 years\n- expected life prognosis shorter than 6 months\n- contracindication of general anestesia\n- 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."}

Primary endpoints

• {"endpoint_text":"- Comparison of cell therapy with standard treatment in several parameters: Assessment of tissue oxygenation – improvement of parameters of ischemia (measured by transcutaneous oxygen pressure andoptionally by other angiological methods)\n- Comparison of cell therapy with standard treatment in several parameters: Clinical effect – wound healing, change in pain, rate of major amputation, amputation-free survival","definition_or_measurement_approach":"- Assessment of tissue oxygenation: measured by transcutaneous oxygen pressure (TcPO2) and optionally by other angiological methods; improvement compared to pre-treatment state (noted in protocol as assessment after 3 months)\n- Clinical effect: wound healing, change in pain, rate of major amputation, and amputation-free survival (specific measurement tools/timepoints not further specified in provided data)"}

Secondary endpoints

• {"endpoint_text":"- Safety: adverse events - expected and unexpected\n- Assesment of study treatment by patients (psychological questionaries)\n- To assess the relation between the quality of cell suspension and tissue oxygenation","definition_or_measurement_approach":"- Safety: collection and reporting of adverse events (expected and unexpected) as safety endpoint (detailed AE collection methods not provided)\n- Patient assessment: psychological questionnaires completed by patients to assess study treatment (specific questionnaires not specified)\n- Relation between quality of cell suspension and tissue oxygenation: assessment of correlation between measures of cell suspension quality and tissue oxygenation (e.g., TcPO2); specific assays/methods not detailed"}

Czechia

Earliest CTIS Part Ii Submission Date

11-12-2024

Latest Decision Or Authorization Date

13-01-2025

Processing Time Days

33

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Institute For Clinical And Experimental Medicine

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia