Wake Forest pilot: placental cell therapy closed diabetic foot ulcers in all 10 patients at 6 months

Researchers at the Wake Forest Institute for Regenerative Medicine (WFIRM) report that an experimental cell therapy closed hard-to-heal diabetic foot ulcers in all ten participants of a pilot study within six months, according to consalud.es consalud.esconsalud.esconsalud.esOpen source ↗. The results were published in Stem Cells Translational Medicine and come from the first trial of this therapy in humans. The authors stress that the results are preliminary.

Diabetic foot ulcers are open wounds that appear when diabetes damages nerves and reduces the ability to feel touch and other sensations. Loss of sensation makes it harder to notice small injuries before they become serious wounds, and these complications are one of the main causes of lower-limb amputation. Options for restoring sensation lost to diabetic peripheral neuropathy are currently limited.

Trial design

The therapy is based on stem cells from healthy placental tissue donated after childbirth, a material that is usually discarded. These cells can modulate inflammation and support tissue repair. The trial enrolled ten adults aged 40 to 74 whose ulcers had stayed open for at least three months despite standard treatment; wound areas ranged from 10 to 100 square centimeters.

Each participant received a single administration of 30, 40 or 60 million cells, injected within and around the lesion and into soft tissue near the foot and ankle. Patients were followed for 12 months, with checks of safety, wound progress, sensation and blood flow consalud.esconsalud.esconsalud.esOpen source ↗. According to co-author Michael Carstens, the main goal was to assess safety.

Results and limitations

All ten ulcers had closed completely by six months. Tests showed improved perception of light touch and vibration in the treated feet. At 12 months, nine of ten patients had regained what the researchers consider normal protective sensation, meaning the ability to detect enough pressure or discomfort to warn of injury. Carstens said the cells were well tolerated within the doses tested, with no serious treatment-related adverse events over the 12 months.

Blood flow did not show a conclusive overall improvement. Seven vessels went from no measurable flow at baseline to measurable circulation after a year, but overall measurements showed both increases and decreases among participants. The authors therefore consider the evidence insufficient to attribute a consistent effect on this parameter to the therapy.

The authors say a larger trial with a comparison group, placebo or another suitable intervention, is needed to determine how much of the effect is due to the treatment. They also propose studying the relationship between dose and ulcer size, analyzing biomarkers of inflammation and tissue repair, and extending follow-up to check whether the benefits persist consalud.esconsalud.esconsalud.esOpen source ↗.