Human amniotic-derived mesenchymal stem cell treatment for calciphylaxis
Effects of Human Amniotic-derived Mesenchymal Stem Cells (hAMSCs) on Calciphylaxis Patients: An Open-Label Single-Arm Study
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 |
| Enrollment | 9 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT04592640 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nanjing, Jiangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.