In short
Clinical trials are studying AUTOLOGOUS BONE MARROW-DERIVED MONONUCLEAR CELLS in people with diabetic foot syndrome and chronic limb-threatening ischemia. These studies look at whether the treatment can improve tissue oxygen, wound healing, pain, and amputation outcomes, and they compare it with standard care or angioplasty.
Key points
- Clinical trials of AUTOLOGOUS BONE MARROW-DERIVED MONONUCLEAR CELLS are being done in patients with diabetes-related leg and foot blood flow problems. One Phase 4 study compares the treatment with standard care in people with chronic limb-threatening ischemia and diabetic foot ulcers who are not eligible for PTA. Another Phase 2 study compares cell therapy plus PTA with PTA alone. The main outcomes include tissue oxygen levels, wound healing, pain, major amputation, and amputation-free survival. The studies also aim to understand possible side effects and complications. Overall, the trials focus on whether this treatment can help save limbs and improve healing in severe diabetic vascular disease.
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. Both trials focus on chronic limb-threatening ischemia, a serious condition where poor blood flow can threaten the limb.
Who is being studied
One trial includes diabetic patients with chronic limb-threatening ischemia and diabetic foot ulcers who are not eligible for PTA. The other trial includes diabetic patients with chronic limb-threatening ischemia and diabetic foot ulcers who can be treated with PTA.
These studies are aimed at patients with advanced limb disease, where wound healing is poor and the risk of amputation is high.
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.
One study compares cell therapy with standard treatment, while the other compares cell therapy plus PTA with PTA alone. PTA stands for percutaneous transluminal angioplasty, a procedure used to open narrowed blood vessels.
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. Its main measurements include transcutaneous oxygen pressure, wound healing, pain change, major amputation rate, and amputation-free survival.
The Phase 2 trial is comparing the effect of cell therapy plus PTA with PTA alone. Its main endpoints are major amputation rate, wound healing, and TcPO2, which is a skin oxygen test that helps show blood flow.
The Phase 2 trial also aims to assess possible side effects and complications of both treatment approaches.
Trial designs and phases
Both studies are interventional, which means the researchers give a treatment and then measure the results. The Phase 2 trial has 110 planned participants, and the Phase 4 trial has 60 planned participants.
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.
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. The studies are especially important for patients with few treatment options, including those who cannot undergo PTA.
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.