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Evaluation of the safety and efficacy of an advanced therapy medicinal product containing live ASCs in the treatment of diabetic foot syndrome.
EU CTIS ID: 2024-518533-29-00
What this study is testing
Clinical evaluation of the effectiveness of treating chronic wounds in diabetic foot syndrome using allogeneic stem cells (ADSC/ASC) compared to a control group. Assessment of early tolerance and safety of using ADSC/ASC in the treatment of chronic wounds in diabetic foot syndrome.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years at the time of consent
- A glycated haemoglobin value (HbA1c) of no more than 11%
- General health status of the patient that, in the opinion of the investigator, allows participation in all study procedures
- A confirmed diagnosis of type 1 diabetes, type 2 diabetes, LADA, MODY, or other types of diabetes, documented in accordance with current diagnostic criteria.
- Use of a form of wound relief recommended by the Investigator
- 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.
You likely can't join if
- Aetiology of ulceration other than diabetic foot syndrome
- Active cancerous process or cancer in the last 5 years, excluding locally malignant tumors that do not involve the tissues of the foo
- Presence of a clinically known active, uncontrolled infection, e.g., Hepatitis B, Hepatitis C, HIV, and venereal disease (syphilis)
- Presence of active infection in the wound at the time of inclusion in the study
- Significant features of malnutrition further impairing the healing process, regardless of the cause (albumin < 2.5 g/dL and total protein < 5g/dL)
- Hemoglobin concentration < 9g/dL
See the full eligibility criteria
Who can join
- Age ≥ 18 years at the time of consent
- A glycated haemoglobin value (HbA1c) of no more than 11%
- General health status of the patient that, in the opinion of the investigator, allows participation in all study procedures
- A confirmed diagnosis of type 1 diabetes, type 2 diabetes, LADA, MODY, or other types of diabetes, documented in accordance with current diagnostic criteria.
- Use of a form of wound relief recommended by the Investigator
- 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.
- Psychophysical and legal capacity of the patient to give informed consent to participate in the study,
- Signature of the informed consent document to participate in the study
- 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)
- A period of not less than 6 weeks since the onset of the ulceration
- Presence of a wound of 1-25 cm2 (after wound debridement)
- 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
What rules you out
- Aetiology of ulceration other than diabetic foot syndrome
- Active cancerous process or cancer in the last 5 years, excluding locally malignant tumors that do not involve the tissues of the foo
- Presence of a clinically known active, uncontrolled infection, e.g., Hepatitis B, Hepatitis C, HIV, and venereal disease (syphilis)
- Presence of active infection in the wound at the time of inclusion in the study
- Significant features of malnutrition further impairing the healing process, regardless of the cause (albumin < 2.5 g/dL and total protein < 5g/dL)
- Hemoglobin concentration < 9g/dL
- Serum transaminase activity (alanine and aspartate) exceeding 3x the upper limit of normal (local)
- Wound area <1cm2 or >25cm2
- Patient was eligible to participate in another clinical trial in the 4 weeks preceding study eligibility
- 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)
- Presence of active phase of Charcot joint
- Pregnancy and lactation
- Osteitis and/or osteomyelitis, including cases assessed using a positive probe-to-bone test.
- Revascularisation procedure in the affected lower limb within less than 3 months prior to study inclusion or planned revascularisation procedure
- Chronic kidney disease with GFR < 20ml/min
- 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.
- Allergy to thrombin
- Active venous thrombosis
- Systemic disease in exacerbation (acute or uncompensated), including heart, kidney and liver disease
- Active alcoholic disease or psychoactive drug addiction
- Allergies to dressing materials used in the study
- Oral/ intravenous antibiotic therapy at the time of study inclusion
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.