Placental Stem Cell Therapy Heals Chronic Diabetic Foot Wounds in Trial

For millions of people living with diabetes worldwide, an untreated foot blister or minor scrape can silently escalate into a life-altering medical emergency. Now, a pioneering first-in-human clinical trial led by researchers at the Wake Forest Institute for Regenerative Medicine (WFIRM) in North Carolina offers a promising new therapeutic avenue. Published in the peer-reviewed journal Stem Cells Translational Medicine, the pilot study demonstrates that investigational stem cells derived from healthy human placental tissue

—typically discarded after childbirth—safely closed stubborn, non-healing diabetic foot ulcers (DFUs) in all 10 trial participants within six months, while also restoring protective nerve sensation in nine out of 10 patients. For patients, endocrinologists, and diabetic foot specialists across Lucknow, New Delhi, Mumbai, Bengaluru, Chennai, Hyderabad, Kolkata, Ahmedabad, and Jaipur—where India carries one of the world’s largest diabetes burdens—these findings point toward a potential future alternative to amputation for chronic wounds that fail standard wound care.

Why Diabetic Foot Ulcers Are So Dangerous and Hard to Heal

Prolonged high blood sugar gradually damages both peripheral nerves (diabetic peripheral neuropathy) and delicate blood vessels in the lower extremities. Because nerve damage numbs pain perception, patients frequently remain unaware of small cuts, friction sores, or pressure injuries on their feet until deep tissue breakdown occurs. Simultaneously, impaired microcirculation deprives damaged skin of oxygen and immune cells, preventing normal tissue repair. According to the American Diabetes Association, roughly one in five patients who develop severe diabetic foot ulcers eventually faces lower-limb amputation—making refractory foot ulcers one of the leading causes of diabetes-related disability worldwide.

Inside the 10-Patient Clinical Trial Using Placenta-Derived Stem Cells

To evaluate whether regenerative cell therapy could jump-start healing in stubborn wounds, researchers led by Dr. Michael H. Carstens

and Dr. Anthony Atala enrolled 10 diabetic patients suffering from large, chronic foot ulcers (measuring 10 to 100 square centimeters) that had failed to heal despite at least three months of standard medical care. Rather than harvesting cells invasively from the patients themselves, scientists isolated specialized placenta-derived stem cells (PSCs)from healthy, donated gestational tissue following routine deliveries—an abundant biological source rich in anti-inflammatory and tissue-repair properties.

Clinicians administered targeted local injections of the placental stem cells directly into the ulcer bed, around the wound perimeter, and along key ankle arteries supplying the foot across three ascending dose levels (30 million, 40 million, and 60 million cells).

Key Clinical Trial Parameter	Verified Study Findings (Stem Cells Translational Medicine)
Lead Research Institution	Wake Forest Institute for Regenerative Medicine (WFIRM), North Carolina, USA
Study Cohort & Criteria	10 diabetic patients with non-healing foot ulcers (10–100 cm²) unresponsive for 3+ months
Cell Source & Dosing	Donated human placenta-derived stem cells (PSCs) injected locally at 30M, 40M, or 60M cells
Wound Closure Outcome	Wound closure began as early as 2 months; 10 out of 10 patients achieved complete healing within 6 months
Nerve Sensation Improvement	Neuropathy improved across all participants; 9 out of 10 regained normal protective sensation by 12 months
12-Month Safety Profile	Cells were well tolerated with zero treatment-related serious adverse events

Complete Wound Closure in Six Months—and Restored Nerve Sensation

Over a 12-month follow-up period

, the clinical outcomes proved remarkably consistent. Visible tissue regeneration and wound closure appeared in two participants within just two months of injection, and by the six-month mark, all 10 patients achieved complete closure of their chronic foot wounds. Equally noteworthy, sensory testing revealed improvements in diabetic peripheral neuropathy across the cohort: by 12 months, nine of the 10 participants regained normal protective sensation—meaning they could once again feel light touch, pressure, and vibration needed to detect foot injuries early.

Early-Stage Safety Focus and the Road Ahead for Larger Trials

Study author Dr. Michael Carstens emphasized that because this was a first-in-human pilot trial, its primary objective was to confirm safety and tolerability—which it achieved with no serious treatment-related adverse events

observed over the entire year. While researchers note that larger, randomized controlled trials are still required before placental stem cell therapy becomes a routine clinical treatment, the study provides compelling early evidence that repurposing discarded placental tissue could transform care for chronic diabetic wounds and peripheral nerve damage.