Human amniotic-derived mesenchymal stem cell treatment for calciphylaxis
Official title: Effects of Human Amniotic-derived Mesenchymal Stem Cells (hAMSCs) on Calciphylaxis Patients: An Open-Label Single-Arm Study
Run by The First Affiliated Hospital with Nanjing Medical University · NCT04592640 · Data updated 2026-11-12
This will try human amniotic-derived mesenchymal stem cells as a treatment for adults 18–75 who have calciphylaxis, including people with chronic kidney disease whether they are on dialysis or not.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 9 (estimated) |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | September 17, 2018 |
| Main results expected | September 17, 2027 |
| Study ends | September 17, 2028 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT04592640 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with a clinical diagnosis of calciphylaxis, including those with chronic kidney disease on dialysis or not, who can give informed consent are ideal candidates.
✕Probably not a fit
Patients with active cancer, severe psychiatric disorders, expected survival under six months, pregnant or breastfeeding women, or those recently enrolled in another experimental drug trial may not be eligible or likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an early phase 1 interventional trial delivering human amniotic-derived mesenchymal stem cells (hAMSCs) to adults with clinically diagnosed calciphylaxis. The primary focus is safety, with participants monitored for adverse events, wound healing, pain, and infection outcomes. Eligible participants are 18–75 years old and must provide informed consent, while people who are pregnant, have active malignancy, severe psychiatric disorder, or very limited life expectancy are excluded. The trial is conducted at hospitals in Nanjing, China, with scheduled treatment and follow-up visits to evaluate short-term tolerability and preliminary signals of benefit.
Why it matters
Potential benefit: If successful, the treatment could reduce pain, promote healing of ischemic skin lesions, lower infection and sepsis risk, and improve survival for patients with calciphylaxis.
How similar studies have gone: Use of amniotic-derived MSCs for calciphylaxis is largely novel, though small studies of mesenchymal stem cells for difficult-to-heal wounds and related conditions have shown promising but preliminary results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-75 years old. 2. Clinical diagnosis of calciphylaxis, including patients with chronic kidney disease who did not or had regular dialysis (hemodialysis or peritoneal dialysis). 3. All subjects signed informed consent. Exclusion criteria: 1. Patients who refuse to sign informed consent. 2. Patients with malignant tumors or severe psychiatric disorders, or an expected survival time of less than 6 months. 3. Pregnant or lactating women of childbearing age. 4. Participation in another clinical trial with an experimental drug within 90 days prior the inclusion.
Where it's running
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The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China Recruiting
Study contacts
- Principal investigator: Ningning Wang, Professor — The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital
- Study coordinator: Ningning Wang, Professor
- Email: wangnn@njmu.edu.cn
- Phone: 86-013813821064
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.