Plain-English translation of NCT04592640 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This trial is testing (hAMSCs) as a treatment for calciphylaxis, a rare and life-threatening condition that causes severely painful skin wounds, especially in people with kidney disease. The stem cells are delivered both through infusions into the bloodstream and injections directly into the affected wounds. Researchers hope this approach will reduce pain, help wounds heal, and improve survival rates.
Calciphylaxis is a devastating condition with very high death rates—up to 80% of dialysis patients die within a year despite current treatments. Currently available therapies focus mainly on wound care and pain management, but they are often not effective enough. This trial explores whether the medication might harness the healing properties of stem cells to treat this life-threatening disease.
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Over 6 months, you would receive a series of stem cell treatments: three infusions given through an IV at weeks 1, 2, and 4, then once every 4 weeks for a total of 8 doses. At the same time, the stem cells would also be injected directly into your wound areas. Your doctor may adjust the treatment schedule based on how you respond. The study includes just 9 participants total, and your treatment plan may be shortened or extended depending on your individual progress.
AI-generated summary from trial data · Jun 18, 2026 · Not medical advice
China
Phase
Safety & dosing
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Westlake University
Enrollment target
~9 participants
Started
September 2018
Primary completion
September 2027
Age range
18 Years – 75 Years
Last updated on clinicaltrials.gov in March 2026.
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Central contact
Ningning Wang, Professor
The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital
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