In the Salamander study, a novel therapy for a treatment called REX-001 will be tested. REX-001 is a cell therapy prepared using the patient’s own bone marrow. REX-001 is expected to resolve the pain at rest that many patients experience, and to also support the healing of wounds on the leg. It is believed that REX-001 works by forming new blood vessels and strengthening existing blood vessels, which should improve the blood flow in the patient’s leg and reduce the symptoms of critical limb ischemia (CLI).
Approximately 60 patients with CLI and rest pain and 78 patients with CLI and non-healing wounds will take part in this research study, at approximately 30 hospitals in Europe. The study is limited to patients with diabetes.
Two-thirds of all patients in the study will receive REX-001 and one third of the patients will receive a placebo treatment. Each patient will be randomly assigned by chance (like drawing straws) to receive either the cell product (REX-001) or a placebo. The placebo product is harmless and consists of a saline solution and several of the patient’s own red blood cells to make it look identical to REX-001.
You, the study doctor and the study staff will not know which therapy you will receive.
Bone marrow will be collected from each patient in the study and REX-001 will be prepared. If a patient is treated with the placebo in the study, REX-001 containing the patient’s cells will be frozen and stored for the duration of the study. Following an initial 12-month follow-up period, each patient treated with the placebo may choose to be treated with the REX-001 treatment that was stored.
Each patient in the study will participate for approximately 2 years. After the treatment with REX-001 or the placebo, the patient will be asked to go back to the hospital 8 times in the 2 years to make sure he or she is doing well and to monitor his or her condition.
There is a distinct reason why this study is called 'Salamander'.
When a salamander loses its tail or limb, it has the ability to grow it back. This regeneration process is being extensively studied, resulting in the development of novel types of treatment.
Treatments containing bone marrow cells mimic the way salamanders grow a new tail or limb and offer the prospect to regenerate blood vessels.