In a nutshell
This study looked at the use of autologous cell therapy (ACT) to treat no-option chronic limb-threatening ischemia (NO-CLTI) in patients with diabetic patients. The study showed that compared to standard treatment, ACT resulted in a significant improvement in ischemia and food healing in these patients.
Diabetes affects blood vessels. Over time, blood vessel damage affects the delivery of oxygen to different parts of the body. When this happens in the feet or legs it is called limb ischemia. Sometimes this can be treated with surgery to improve the blood supply to the limb. However, when it is very severe surgery is not possible. This is called no-option chronic limb-threatening ischemia (NO-CLTI).
Standard treatment for NO-CLTI involves medications to reduce blood clotting. However, this treatment is not very effective and this condition often results in amputation of the leg or foot.
Autologous cell therapy (ACT) is a treatment in which cells are taken from a patient’s bone marrow or peripheral blood and injected into another part of the body to promote healing. It is not clear whether ACT is an effective treatment for NO-CLTI.
Methods & findings
40 patients with NO-CLTI were involved in this study. Patients were divided into 2 groups. Group 1 received standard treatment for 12 weeks, followed by ACT. Group 2 received ACT straight away for 24 weeks. Transcutaneous oxygen pressure (TcPO2) was measured to monitor the amount of oxygen getting to the limb. Patients were also reviewed to determine how many patients’ wounds healed during the study.
After 12 weeks of standard therapy, 0 patients had their wounds healed in group 1. In group 2, 31.3% of patients had healed wounds after 12 weeks of ACT treatment.
The oxygen delivery in group 2 also improved by 21.1 mmHg after ACT treatment (from 20.8 mmHg to 41.9 mmHg) after the first 12 weeks, which was maintained up to week 24. There was no significant change in oxygen delivery in group 1 after 12 weeks of standard treatment. However, after patients in group 1 were switched to ACT, there was a significant increase in oxygen delivery from 20.1mmHg to 41.9mmHg from week 12 to week 24.
After the first 12 weeks, there was a significant reduction in pain in group 2, while group 1 reported an increase in pain. There was also a significant increase in quality of life after 12 weeks of ACT in group 2. Group 1 did not report any changes in quality of life.
Side effects reported after ACT included bleeding during the extraction of bone marrow (1 patient) and short-term swelling of the limb after the injection of the cell therapy (1 patient).
The bottom line
This study showed that ACT is an effective treatment for diabetic patients with NO-CLTI.
The fine print
This was a very small trial in one center. Larger studies are needed to confirm these results.
Published By :
Frontiers in Endocrinology
Original Title :
Comparison of the impact of autologous cell therapy and conservative standard treatment on tissue oxygen supply and course of the diabetic foot in patients with chronic limb-threatening ischemia: A randomized controlled trial.