In a small first step, a team of researchers has tested whether cells drawn from placental tissue, normally discarded after childbirth, might help a stubborn kind of wound heal. Ten adults in Nicaragua, whose diabetic foot ulcers had resisted months of ordinary care, received a single round of injections, and every wound had closed within half a year. The work speaks to a long human struggle, one in which a lost sensation in the foot can quietly lead to amputation, and it offers encouragement without yet offering proof. Whether this hope will hold depends on the larger, controlled studies its
Placental Stem Cell Therapy Closes Diabetic Foot Ulcers in Small First-in-Human Trial
Ten adults aged 40 to 74 with chronic diabetic foot ulcers open for at least three months were treated in the study, with wounds ranging from 10 to 100 cm².
All 10 wounds had closed by the six-month mark.
Mark
Ten people, all wounds closed. Why is this getting attention?
Mimi
These were chronic ulcers, open at least three months despite standard care, and some were as large as 100 square centimeters. Closing every one within six months is notable for that group.
Mark
And the sensation result?
Mimi
That may be the more unusual part. Most treatments manage symptoms. Here, all but one person had normal protective sensation by 12 months.
Luke
Before we get carried away: there was no control group. We can't say the cells did this. Some wounds might have closed with continued care.
Mimi
The researchers say as much. They recommend a placebo-controlled trial for that reason.
Mark
What was the study actually built to answer?
Mimi
Safety. Michael Carstens said it was designed foremost for that, and no treatment-related serious adverse events appeared over 12 months.
Luke
Ten people is a very small base for a safety claim, though. A rare problem could easily be missed.
Mimi
Fair. Also, blood flow didn't clearly improve. Seven vessels gained measurable flow, but others went up and down.
Luke
And we don't know the best dose. Three dose groups of three or four people can't separate them.
Mark
So what's next?
Mimi
A larger controlled trial, dosing by wound size, testing both legs, and longer follow-up to see if the gains last.
Der Puls
- Ten adults with wounds open for months faced the real threat of amputation, and their injuries were among the largest the researchers had seen.
- A single injection of experimental placental cells was given to each participant, and the treatment was measured against a backdrop of standard local care alone.
- Every wound closed within six months, and most participants regained the protective sensation that diabetic nerve damage had taken away.
- Blood flow results remained inconclusive, and without a comparison group the researchers cannot yet say how much healing came from the cells themselves.
In a small first step, a team of researchers has tested whether cells drawn from placental tissue, normally discarded after childbirth, might help a stubborn kind of wound heal. Ten adults in Nicaragua, whose diabetic foot ulcers had resisted months of ordinary care, received a single round of injections, and every wound had closed within half a year. The work speaks to a long human struggle, one in which a lost sensation in the foot can quietly lead to amputation, and it offers encouragement without yet offering proof. Whether this hope will hold depends on the larger, controlled studies its authors now call for.
Ten adults in Nicaragua lived with diabetic foot ulcers that had stayed open for at least three months, despite the best care available locally. Their wounds were large, between 10 and 100 square centimeters, and their ages ranged from 40 to 74. In a first-in-human study led by researchers at the Wake Forest Institute for Regenerative Medicine, each received one round of injections containing cells derived from healthy placental tissue, the kind of material usually thrown away after birth.
The primary purpose of the study was safety, and the team reported that the cells were well tolerated across a year of follow-up, with no treatment-related serious adverse events. The participants were watched closely in the hospital and checked on weekly for three weeks, then evaluated at intervals up to twelve months.
The results went beyond the wounds themselves. Diabetic foot ulcers often arise when nerve damage numbs a person's feet, and by twelve months nearly all participants had regained normal protective sensation, enough to feel the pressure or discomfort that warns of injury. Blood flow results, however, were mixed, and the study had no comparison group, so the researchers caution that they cannot yet separate the cells' effect from the body's own healing.
The team now calls for larger, placebo-controlled trials to confirm the benefit, refine the dose, and determine whether the gains last.
Ten adults in Nicaragua, each with a diabetic foot ulcer that had stayed open for at least three months despite standard local care, received a single round of injections of experimental stem cells. Within six months, every one of their wounds had closed. That result comes from a first-in-human study led by researchers at the Wake Forest Institute for Regenerative Medicine, published last week in Stem Cells Translational Medicine.
The participants ranged in age from 40 to 74. Their ulcers were large, between 10 and 100 square centimeters. The study was conducted in Nicaragua, where, according to the researchers, such ulcers are more common and more severe than in the United States, and amputation rates are higher. The trial was registered at ClinicalTrials.gov as NCT06373809 and approved by the country's Ministry of Health.
The cells were derived from healthy placental tissue donated after childbirth, tissue that is normally discarded. The researchers say it contains cells with properties that may help control inflammation and support tissue repair. Each participant received one treatment of 30 million, 40 million or 60 million cells, injected into and around the wound and into nearby soft tissue in the foot and ankle. Four people received the lowest dose, three the middle dose and three the highest.
After treatment, participants were monitored in the hospital and contacted weekly for the first three weeks. They were then evaluated at one, three, six and 12 months for safety, wound healing, sensation and blood flow in the foot and ankle.
Safety was the main question. Michael Carstens, M.D., an author of the study, said the early work was designed foremost to answer it. Within the doses tested, he said, the cells were well tolerated, and the team saw no treatment-related serious adverse events across the 12 months of follow-up.
Sensation is where the findings reach beyond wound care. Diabetic foot ulcers tend to develop when nerve damage dulls a person's ability to feel injuries, and they are the leading cause of lower-limb amputation in the United States. Neuropathy is generally managed by controlling diabetes and treating symptoms; options for restoring lost sensation are limited. In this study, tests showed improved ability to feel light touch and vibration in the treated foot. By 12 months, all but one participant had regained what the researchers classified as normal protective sensation, meaning enough ability to feel discomfort or pressure to recognize a possible injury. Anthony Atala, M.D., corresponding author and director of the institute, called the improvements in wound healing and in two measures of sensation encouraging, while noting that further studies are needed.
Blood flow told a less clear story. The researchers found no definite overall improvement. Seven blood vessels went from no measurable flow at the start to measurable flow at 12 months, but results across participants included both increases and decreases.
The study has no comparison group, so it cannot say how much of the healing came from the cells themselves. The researchers recommend a larger controlled trial with a placebo or other appropriate comparison, which could also help settle the right dose. They suggest future work might adjust dose by wound size, treat diabetic peripheral neuropathy as a formal outcome, test sensation in both legs, study biological markers of inflammation and healing, and follow participants longer to see whether the gains last and the therapy stays safe.
Bemerkenswerte Zitate
The early study was designed foremost to answer a safety question; the cells were well tolerated and no treatment-related serious adverse events were seen in 12 months.— Michael Carstens, M.D., study author
The improvements in wound healing and two measures of sensation are encouraging, but further studies are needed.— Anthony Atala, M.D., corresponding author and WFIRM director
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