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Study on the Safety and Effectiveness of Allogenic Stem Cells for Treating Diabetic Foot Ulcers in Patients with Diabetes

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of diabetic foot ulcers, a common complication in people with diabetes where wounds on the feet do not heal properly. The study will use a treatment involving allogenic adipose-tissue-derived mesenchymal stem cells, also known as alloADSC-DFU-RL or CellReady. These are special cells taken from fat tissue that have the potential to help heal wounds. The purpose of the study is to evaluate the safety and effectiveness of this advanced therapy in treating chronic wounds associated with diabetic foot syndrome.

Participants in the study will be randomly assigned to receive either the stem cell treatment or a placebo. The treatment will be applied directly to the wound as a cell suspension, which is a liquid containing the stem cells. The study will last for a period of six weeks, during which the healing progress of the wounds will be closely monitored. Researchers will assess changes in the size of the wound, any side effects experienced, and overall health improvements. The study aims to determine if the stem cell treatment can lead to significant wound healing compared to the placebo.

Throughout the study, participants will undergo regular check-ups to monitor their health and the healing of their wounds. The study will also evaluate the need for additional treatments, such as antibiotics, and any changes in the participants' quality of life. The ultimate goal is to find a safe and effective treatment option for those suffering from diabetic foot ulcers, potentially improving their healing process and overall well-being.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
The study begins with an initial assessment to confirm eligibility. This includes checking the presence of a diabetic foot ulcer, ensuring the wound is between 1-25 cm², and confirming satisfactory blood supply to the wound area.
A glycated hemoglobin (HbA1c) test is conducted to ensure it is no more than 11%. The general health status is evaluated to ensure participation in all study procedures.
Step 2
Consent and preparation
Informed consent is obtained after explaining the study details. The patient must agree to use effective contraception if applicable.
A negative pregnancy test is required for women capable of having offspring before the first dose of the study product.
Step 3
Treatment phase
The treatment involves the application of a cell suspension containing allogenic adipose-tissue-derived mesenchymal stem cells (ADSC/ASC) for topical use.
The treatment is administered over a period of 6 weeks. The frequency and specific dosage are determined by the study protocol.
Step 4
Monitoring and evaluation
Throughout the treatment phase, the wound surface area is monitored for changes. The type, frequency, and severity of any adverse events are recorded.
Laboratory tests and vital parameters are assessed at the end of the active treatment phase, 6 weeks after the first administration of ADSC/ASC.
Step 5
Follow-up assessments
The study evaluates the percentage of patients achieving significant clinical success, defined as complete or partial wound epithelialization.
Pain perception is assessed using the Visual Analogue Scale (VAS), and quality of life parameters are evaluated using the EQ-5D-5L questionnaire at the end of the active treatment phase and at the end of the study.

Who can join the trial?

11 criteria

Must be over 18 years old at the time of agreeing to participate.
Must use a type of wound care recommended by the study doctor.
Must use effective birth control to prevent pregnancy. Women who cannot have children (due to surgery or menopause) do not need pregnancy tests. Women who can have children must have a negative pregnancy test before starting the study and agree to regular tests and use birth control until one month after the study ends or two months after the last study treatment.
Must be able to understand and agree to participate in the study.
Must sign a document agreeing to participate in the study.
Must have a foot ulcer related to diabetes, classified as neuropathic (nerve-related) or neuropathic/ischemic (nerve and blood flow-related) according to a specific classification system.
The ulcer must have been present for at least 6 weeks.
The wound size must be between 1 and 25 square centimeters after cleaning.
Must have good blood flow to the wound area, measured by oxygen levels or blood pressure in the foot, to ensure no need for blood flow improvement treatments.
Must have a glycated hemoglobin (HbA1c) level of no more than 11%. This is a measure of blood sugar control over time.
Must be in good general health, as determined by the study doctor, to participate in all study activities.

Who cannot join the trial?

3 criteria

Patients who do not have a diabetic foot ulcer cannot participate. A diabetic foot ulcer is a sore or wound on the foot that occurs in people with diabetes.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation.

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Verified sites

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Verified
Szpital Bielanski Im.Ks.Jerzego Popieluszki samodzielny publiczny zakład opieki zdrowotnej
Warsaw, Poland
Responsive
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland

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Investigated drugs

Allogeneic Stem Cells (ADSC/ASC) are being tested in this clinical trial to see if they can help heal chronic wounds in people with diabetic foot syndrome. These stem cells are taken from donors and are used to promote healing and tissue repair. The study aims to determine if these cells can effectively treat the wounds and how well patients tolerate them.

What is already known about the treatment

Allogeneic Stem Cells (ADSC/ASC) – This medication is administered through direct application to the wound site, typically in a clinical setting. It is currently being evaluated in clinical trials for its safety and effectiveness in treating diabetic foot ulcers. The main therapeutic indication is the treatment of chronic wounds associated with diabetic foot syndrome. At the molecular level, these stem cells work by promoting tissue regeneration and reducing inflammation, aiding in the healing process. They are classified under advanced therapy medicinal products, specifically focusing on regenerative medicine.

Investigated diseases

Diabetic Foot Ulcer – Diabetic foot ulcer is a common complication of diabetes, characterized by open sores or wounds that typically occur on the bottom of the foot. It develops due to a combination of factors, including poor blood circulation and nerve damage caused by high blood sugar levels. The progression of the ulcer can be slow, and it may become larger and deeper over time if not properly managed. These ulcers can be prone to infection, which can further complicate the healing process. Regular monitoring and care are essential to prevent the ulcer from worsening.