Ongoing Clinical Trials for Peripheral Ischaemia
Currently, there is 1 ongoing clinical trial investigating new treatment approaches for peripheral ischaemia, specifically focusing on patients with diabetic foot syndrome and poor blood flow to the lower limbs. This trial is being conducted in Czechia and is testing an innovative cell therapy approach using the patient’s own bone marrow cells.
Clinical trial locations
Study on the Effects of Autologous Bone Marrow-Derived Mononuclear Cells for Patients with Diabetic Foot Syndrome and Lower Limb Ischemia
This trial is investigating a new approach for treating patients who have serious complications from diabetes, specifically those with poor blood flow to their legs and diabetic foot ulcers. These conditions can cause severe pain, slow-healing wounds, and in serious cases, may require amputation.
Who can participate:
- Adults between 18 and 90 years old
- People with type 1 or type 2 diabetes
- Patients with diabetic foot ulcers below the ankle or those who have had a minor amputation
- Patients with chronic limb-threatening ischemia, confirmed by medical tests showing blood flow measurement under 40 mm Hg
- Those who can provide signed informed consent to participate
Who cannot participate:
- Patients with conditions other than diabetic foot syndrome or lower limb ischemia
- Patients who are eligible for PTA, a procedure that opens blocked blood vessels
- Patients outside the specified age range
- Patients who belong to a vulnerable population
What the trial is testing:
The trial is comparing two treatment approaches. The first is a new cell therapy called autologous bone marrow-derived mononuclear cells, also known as REX-001. This treatment involves taking special cells from the patient’s own bone marrow and injecting them back into the body through the muscles. These cells are intended to help improve blood flow and promote healing of ulcers. The second approach is the standard treatment currently available for these conditions.
The main goal of this study is to see if the cell therapy can improve tissue oxygenation, which means increasing the amount of oxygen reaching the tissues in the affected leg. Researchers will also monitor whether this leads to better wound healing, reduced pain, and a lower risk of needing major amputations.
Throughout the study, researchers will carefully monitor the safety of the cell therapy by tracking any side effects. Patients will also be asked to complete questionnaires about their experience with the treatment. The study will examine how the quality of the cell preparation relates to improvements in blood flow and healing. The trial is expected to continue until the end of 2027, providing important information about whether this innovative treatment can help patients with these challenging conditions.
Summary
The current clinical trial landscape for peripheral ischaemia shows focused research on regenerative medicine approaches for diabetic complications. With only one ongoing trial, it is being conducted in Czechia and specifically targets patients with diabetic foot syndrome and chronic limb-threatening ischemia. The trial is testing autologous bone marrow-derived mononuclear cell therapy, representing an innovative approach in regenerative medicine that uses the patient’s own cells to promote healing and improve blood flow. This study is particularly important for patients who are not eligible for standard procedures like angioplasty, offering a potential alternative treatment option for those with limited therapeutic choices.