Table of Contents
- Trial overview
- Who is being studied
- What is being tested
- Trial goals and main endpoints
- Trial designs and phases
- What the trial results may mean
Trial overview
Two authorised interventional trials are studying AUTOLOGOUS BONE MARROW-DERIVED MONONUCLEAR CELLS in people with severe diabetes-related blood flow problems in the legs and feet.[1][2] Both trials focus on chronic limb-threatening ischemia, a serious condition where poor blood flow can threaten the limb.[1][2]
Who is being studied
One trial includes diabetic patients with chronic limb-threatening ischemia and diabetic foot ulcers who are not eligible for PTA.[1] The other trial includes diabetic patients with chronic limb-threatening ischemia and diabetic foot ulcers who can be treated with PTA.[2]
These studies are aimed at patients with advanced limb disease, where wound healing is poor and the risk of amputation is high.[1][2]
What is being tested
In both trials, the study treatment is a suspension of autologous mononuclear cells separated from bone marrow aspirate, given by intramuscular injection, which means injection into the muscle.[1][2]
One study compares cell therapy with standard treatment, while the other compares cell therapy plus PTA with PTA alone.[1][2] PTA stands for percutaneous transluminal angioplasty, a procedure used to open narrowed blood vessels.[2]
Trial goals and main endpoints
The Phase 4 trial is checking whether cell therapy can improve tissue oxygenation and clinical outcomes compared with standard treatment.[1] Its main measurements include transcutaneous oxygen pressure, wound healing, pain change, major amputation rate, and amputation-free survival.[1]
The Phase 2 trial is comparing the effect of cell therapy plus PTA with PTA alone.[2] Its main endpoints are major amputation rate, wound healing, and TcPO2, which is a skin oxygen test that helps show blood flow.[2]
The Phase 2 trial also aims to assess possible side effects and complications of both treatment approaches.[2]
Trial designs and phases
Both studies are interventional, which means the researchers give a treatment and then measure the results.[1][2] The Phase 2 trial has 110 planned participants, and the Phase 4 trial has 60 planned participants.[1][2]
Phase 2 studies usually help test whether a treatment may work and whether it is worth studying further, while Phase 4 studies are later-stage studies done after earlier testing.[1][2]
What the trial results may mean
These trials are trying to find out whether AUTOLOGOUS BONE MARROW-DERIVED MONONUCLEAR CELLS can help improve blood flow-related measures, support wound healing, and lower the chance of major amputation in severe diabetic limb disease.[1][2] The studies are especially important for patients with few treatment options, including those who cannot undergo PTA.[1]
Because the trials compare the treatment with standard care or with PTA alone, they may help show whether the added cell therapy gives extra benefit in this patient group.[1][2]
