ALLOGENIC ADIPOSE-TISSUE-DERIVED MESENCHYMAL STEM CELLS for Diabetic foot ulcer

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years at the time of consent\n- A glycated haemoglobin value (HbA1c) of no more than 11%\n- General health status of the patient that, in the opinion of the investigator, allows participation in all study procedures\n- A confirmed diagnosis of type 1 diabetes, type 2 diabetes, LADA, MODY, or other types of diabetes, documented in accordance with current diagnostic criteria.\n- Use of a form of wound relief recommended by the Investigator\n- In the case of women of childbearing potential, agreement to use of methods of effective contraception to avoid pregnancy and/or based on the following criteria: - a woman who is incapable of having offspring (after hysterectomy or bilateral ovarian resection or after menopause, defined as a period of at least 12 months since the last menstrual period) is exempt from pregnancy testing - a woman capable of having offspring with a negative pregnancy test result prior to the first day dose of the study product and who agrees to cycle pregnancy tests according to the study protocol and to use appropriate contraception until one month after the end of the active phase of the study (up to V6), or 2 months after the last administration of the study drug. For men – fertile men who are sexually active with a partner who may become pregnant are required to use a barrier method throughout the entire duration of the study, and the partners of study participants (who are capable of bearing children) are required to use the same contraceptive methods as female study participants until Visit V6.\n- Psychophysical and legal capacity of the patient to give informed consent to participate in the study,\n- Signature of the informed consent document to participate in the study\n- Ulceration classified as diabetic foot syndrome (ZSC) with neuropathic and/or neuropathic/ischemic aetiology corresponding to grade IA/IIA and IC/IIC according to the University of Texas classification (Appendix E)\n- A period of not less than 6 weeks since the onset of the ulceration\n- Presence of a wound of 1-25 cm2 (after wound debridement)\n- Satisfactory blood supply to the wound area (assessed by transcutaneous measurement of oxygen partial pressure, if not less than 30 mmHg, or measurement of systolic arterial pressure on the posterior tibial and/or dorsal artery of the foot, which will not be less than 50 mmHg) to exclude patients who require revascularisation therapy"}

Exclusion criteria

• {"criterion_text":"- Aetiology of ulceration other than diabetic foot syndrome\n- Pregnancy and lactation\n- Allergy to thrombin\n- Active venous thrombosis\n- Systemic disease in exacerbation (acute or uncompensated), including heart, kidney and liver disease\n- Active alcoholic disease or psychoactive drug addiction\n- Allergies to dressing materials used in the study\n- Oral/ intravenous antibiotic therapy at the time of study inclusion\n- A patient undergoing immunosuppressive therapy, including systemic corticosteroid therapy (within 30 days prior to study inclusion). Topical corticosteroid therapy does not constitute an exclusion criterion.\n- Active cancerous process or cancer in the last 5 years, excluding locally malignant tumors that do not involve the tissues of the foo\n- Presence of a clinically known active, uncontrolled infection, e.g., Hepatitis B, Hepatitis C, HIV, and venereal disease (syphilis)\n- Presence of active infection in the wound at the time of inclusion in the study\n- Significant features of malnutrition further impairing the healing process, regardless of the cause (albumin < 2.5 g/dL and total protein < 5g/dL)\n- Hemoglobin concentration < 9g/dL\n- Serum transaminase activity (alanine and aspartate) exceeding 3x the upper limit of normal (local)\n- Wound area <1cm2 or >25cm2\n- Patient was eligible to participate in another clinical trial in the 4 weeks preceding study eligibility\n- Clinically significant limb ischaemia (assessed by transcutaneous measurement of oxygen partial pressure if less than 30 mmHg or measurement of systolic arterial pressure on the posterior tibial and dorsal artery of the foot which is less than 50 mmHg)\n- Presence of active phase of Charcot joint\n- Osteitis and/or osteomyelitis, including cases assessed using a positive probe-to-bone test.\n- Revascularisation procedure in the affected lower limb within less than 3 months prior to study inclusion or planned revascularisation procedure\n- Chronic kidney disease with GFR < 20ml/min\n- Patients undergoing immunotherapy for allergic diseases (within 30 days prior to the screening visit — calculated from the last dose of such therapy) or those planning to initiate or resume such therapy during the clinical trial."}

Primary endpoints

• {"endpoint_text":"- Change in wound surface area","definition_or_measurement_approach":""}
• {"endpoint_text":"- Type, frequency, and severity of adverse events","definition_or_measurement_approach":""}
• {"endpoint_text":"- Changes in laboratory tests and vital parameters Assessment time point: at the end of the active treatment phase (6 weeks after the first administration of ADSC/ASC)","definition_or_measurement_approach":"Assessment time point: at the end of the active treatment phase (6 weeks after the first administration of ADSC/ASC)"}

Secondary endpoints

• {"endpoint_text":"- Total percentage of patients with significant clinical success defined as achieving a specified degree of wound epithelialization: *Complete wound closure (100% epithelialization), or *Partial wound epithelialization (>50% epithelialization)","definition_or_measurement_approach":"Percentage of patients achieving 100% epithelialization or >50% epithelialization"}
• {"endpoint_text":"- Parameters for assessing clinical efficacy: *Change in wound surface area over time measured from the first administration of the treatment under investigation *Percentage of patients with significant clinical success over time assessed as complete wound closure (100% epithelialization), or partial wound epithelialization (>50% epithelialization)","definition_or_measurement_approach":"Change in wound surface area measured from first administration; percentage with complete or partial epithelialization over time"}
• {"endpoint_text":"- Dynamics of wound healing assessed as: *Time to achieve a 50% reduction in wound surface area *Time to achieve the greatest reduction in wound surface area *Time to achieve complete wound closure (100% epithelialization)","definition_or_measurement_approach":"Time-to-event measures: time to 50% reduction, time to greatest reduction, time to complete closure"}
• {"endpoint_text":"- Absolute change in pain perception over time assessed using the Visual Analogue Scale (VAS).","definition_or_measurement_approach":"Pain measured by Visual Analogue Scale (VAS) over time"}
• {"endpoint_text":"- The need for antibiotic therapy due to wound infection *Number of patients *Number of antibiotic therapies *Assessment time points: at the end of the active treatment phase (6 weeks after the first administration of ADSC/ASC) and at the end of the study","definition_or_measurement_approach":"Counts of patients requiring antibiotics and number of antibiotic therapies; assessment at end of active treatment (6 weeks) and at end of study"}
• {"endpoint_text":"- Change in quality of life parameters according to the EQ-5D-5L questionnaire Assessment time points: at the end of the active treatment phase (6 weeks after the first administration of ADSC/ASC) and at the end of the study","definition_or_measurement_approach":"EQ-5D-5L questionnaire administered at end of active treatment (6 weeks) and at end of study"}

Poland

Earliest CTIS Part Ii Submission Date

08-11-2024

Latest Decision Or Authorization Date

13-04-2026

Processing Time Days

521

Number Of Sites

2

Number Of Participants

105

Primary sponsor

Full Name

Medical University Of Warsaw

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Scientia Research Institute Sp. z o.o.","duties_or_roles":"1,12,6,7,8,9","organisation_type":"Pharmaceutical company"}