Evaluation of the safety and efficacy of an advanced therapy medicinal product containing live ASCs in the treatment of diabetic foot syndrome.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Warsaw

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

5 Mar 2025 → ongoing

Decision date (initial)

2024-12-16

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Medical Research Agency

External identifiers

EU CT number

2024-518533-29-00

EudraCT number

2022-001083-94

ClinicalTrials.gov

NCT06843122

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Dose response, Therapy

*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.

Secondary objectives 6

1. Clinical evaluation of the effectiveness of the treatment method for chronic wounds in diabetic foot syndrome using allogeneic stem cells (ADSC/ASC) compared to a control group.
2. Long-term clinical evaluation of the effectiveness of the treatment method for chronic wounds in diabetic foot syndrome using allogeneic stem cells (ADSC/ASC) compared to a control group.
3. Assessment of the dynamics of chronic wound healing parameters in diabetic foot syndrome using ADSC/ASC compared to a control group.
4. Evaluation of changes in subjective pain perception associated with the wound in patients treated with the ADSC/ASC method compared to a control group.
5. Assessment of selected safety and efficacy parameters of the therapy in patients treated with the ADSC/ASC method compared to a control group.
6. Evaluation of changes in quality of life in patients treated with the ADSC/ASC method compared to a control group.

Conditions and MedDRA coding

DIABETIC FOOT ULCER

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Age ≥ 18 years at the time of consent
2. Use of a form of wound relief recommended by the Investigator
3. 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.
4. Psychophysical and legal capacity of the patient to give informed consent to participate in the study,
5. Signature of the informed consent document to participate in the study
6. 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)
7. A period of not less than 6 weeks since the onset of the ulceration
8. Presence of a wound of 1-25 cm2 (after wound debridement)
9. 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
10. A glycated haemoglobin value (HbA1c) of no more than 11%
11. General health status of the patient that, in the opinion of the investigator, allows participation in all study procedures
12. A confirmed diagnosis of type 1 diabetes, type 2 diabetes, LADA, MODY, or other types of diabetes, documented in accordance with current diagnostic criteria.

Exclusion criteria 23

1. Aetiology of ulceration other than diabetic foot syndrome
2. Pregnancy and lactation
3. Allergy to thrombin
4. Active venous thrombosis
5. Systemic disease in exacerbation (acute or uncompensated), including heart, kidney and liver disease
6. Active alcoholic disease or psychoactive drug addiction
7. Allergies to dressing materials used in the study
8. Oral/ intravenous antibiotic therapy at the time of study inclusion
9. 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.
10. Active cancerous process or cancer in the last 5 years, excluding locally malignant tumors that do not involve the tissues of the foo
11. Presence of a clinically known active, uncontrolled infection, e.g., Hepatitis B, Hepatitis C, HIV, and venereal disease (syphilis)
12. Presence of active infection in the wound at the time of inclusion in the study
13. Significant features of malnutrition further impairing the healing process, regardless of the cause (albumin < 2.5 g/dL and total protein < 5g/dL)
14. Hemoglobin concentration < 9g/dL
15. Serum transaminase activity (alanine and aspartate) exceeding 3x the upper limit of normal (local)
16. Wound area <1cm2 or >25cm2
17. Patient was eligible to participate in another clinical trial in the 4 weeks preceding study eligibility
18. 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)
19. Presence of active phase of Charcot joint
20. Osteitis and/or osteomyelitis, including cases assessed using a positive probe-to-bone test.
21. Revascularisation procedure in the affected lower limb within less than 3 months prior to study inclusion or planned revascularisation procedure
22. Chronic kidney disease with GFR < 20ml/min
23. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Change in wound surface area
2. Type, frequency, and severity of adverse events
3. 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)

Secondary endpoints 6

1. 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)
2. 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)
3. 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)
4. Absolute change in pain perception over time assessed using the Visual Analogue Scale (VAS).
5. 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
6. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Warsaw

Sponsor organisation

Medical University Of Warsaw

Address

Ul. Zwirki I Wigury 61

City

Warsaw

Postcode

02-091

Country

Poland

Scientific contact point

Organisation

Medical University Of Warsaw

Contact name

Study Coordinator

Public contact point

Organisation

Medical University Of Warsaw

Contact name

Study Coordinator

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications