A comparison of the effect of autologous bone marrow-derived mononuclear cell therapy with standard treatment on ischemia parameters in diabetic patients with chronic limb-threatening ischemia

Phase 2/3

Not yet recruiting

• Conditions: diabetic foot syndrome; lower limb ischemia

• Registration Number: 2024-519687-40-00
• Lead Sponsor: Institute For Clinical And Experimental Medicine

Brief Summary

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 chronic limb-threatening ischemia (CLTI) and diabetic foot ulcers (DFU) not eligible for PTA and to verify the effect of repetitive cell therapy.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

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

presence of chronic limb-threatening ischemia attributable to objectively proven arterial occlusive disease; (TcPO2) under 40 mm Hg, indication for PTA

age 18-90 years

diabetes mellitus type 1 or 2

signed informed consent

Exclusion Criteria

severe active deep infection of DFU

pregnant women – the test of pregnancy is the part of the examination before inclusion into the study

deep vein thrombosis less than 6 months

severe limb oedema that rule out intramuscular injection of cell suspension

severe non-treated diabetic retinopathy requiring acutely a laser therapy

severe haematological disease

diagnosed neoplastic process of any organ less than 5 years

expected life prognosis shorter than 6 months

contracindication of general anestesia

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: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)		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)
Comparison of cell therapy with standard treatment in several parameters: Clinical effect – wound healing, change in pain, rate of major amputation, amputation-free survival		Comparison of cell therapy with standard treatment in several parameters: Clinical effect – wound healing, change in pain, rate of major amputation, amputation-free survival

Secondary Outcome Measures

Name	Time	Method
Safety: adverse events - expected and unexpected		Safety: adverse events - expected and unexpected
Assesment of study treatment by patients (psychological questionaries)		Assesment of study treatment by patients (psychological questionaries)
To assess the relation between the quality of cell suspension and tissue oxygenation		To assess the relation between the quality of cell suspension and tissue oxygenation

Trial Locations

Locations (1)

Institute For Clinical And Experimental Medicine; 🇨🇿 Prague, Czechia

Institute For Clinical And Experimental Medicine

🇨🇿Prague, Czechia

Michal Dubský

Site contact

420236052150

michal.dubsky@ikem.cz