Stem cell treatment shows promise for stubborn leg wounds

NCT ID NCT06489028

Ongoing Disease control Sponsor: RHEACELL GmbH & Co. KG Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests a donor stem cell treatment called Allo-APZ2-CVU for people with chronic venous leg ulcers that haven't healed with standard therapy. About 250 adults with ulcers between 1 and 25 cm² will receive either the cell therapy or a placebo applied directly to the wound. The main goal is to see if the treatment leads to complete wound closure lasting at least two weeks.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Allo-APZ2-CVU (a type of donor stem cells applied to the wound)
What this could lead to: If it works, this could offer a new treatment option for people with chronic leg ulcers that haven't healed with standard care.
What could go wrong: This is still being tested in a late-stage trial, so results are not yet confirmed. The treatment may not work better than placebo, and there could be side effects from the cell therapy.

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Conditions

The condition(s) this trial relates to.

chronic ulcer of skin Skin Ulcer ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

VENOUS LEG ULCER

Contacts and locations

Locations

RHEACELL Clinical Trial Site

Hialeah, Florida, 33012, United States
RHEACELL Clinical Trial Site

Miami, Florida, 33136, United States
RHEACELL Clinical Trial Site

Boston, Massachusetts, 02114, United States
RHEACELL Clinical Trial Site

Minneapolis, Minnesota, 55455, United States
RHEACELL Clinical Trial Site

Multiple Locations, Austria
RHEACELL Clinical Trial Site

Multiple Locations, Czechia
RHEACELL Clinical Trial Site

Multiple Locations, France
RHEACELL Clinical Trial Site

Several Locations, Germany
RHEACELL Clinical Trial Site

Multiple Locations, Hungary
RHEACELL Clinical Trial Site

Multiple Locations, Italy
RHEACELL Clinical Trial Site

Multiple Locations, Netherlands
RHEACELL Clinical Trial Site

Multiple Locations, Poland
RHEACELL Clinical Trial Site

Multiple Locations, Slovakia
RHEACELL Clinical Trial Site

Multiple Locations, Sweden
RHEACELL Clinical Trial Site

Multiple Locations, United Kingdom

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