NCT04592640

Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis

Effects of Human Amniotic-derived Mesenchymal Stem Cells (hAMSCs) on Calciphylaxis Patients: An Open-Label Single-Arm Study

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells

Detailed description

Calciphylaxis is a rare, devastating disorder causing excruciatingly painful ischemic skin lesions. Sepsis due to the infection of ulcerated wounds is a common cause of death. To date, practical therapies typically include wound care, pain management, anti-infection, anticoagulant and aggressive treatment of predisposing conditions. Drugs such as sodium thiosulfate(STS), bisphosphonate, SNF472 and cinacalcet are also suggested. However, it's still a lethal disease with 1-year mortality up to 80% for dialysis patients. Here the investigators plan to treat calciphylaxis patients with human amniotic-derived mesenchymal stem cells (hAMSCs).

Conditions

• Chronic Kidney Diseases
• Calciphylaxis
• Calcific Uremic Arteriolopathy
• Treatment
• Safety
• Efficacy

Interventions

Type	Name	Description
BIOLOGICAL	Human amniotic-derived mesenchymal stem cells	(1) Intravenous infusion: 1.0×10⁶ cells/kg administered three times consecutively at weeks 1, 2, and 4, followed by once every 4 weeks for a total of 8 doses (6 months). (2) Local injection: 2.0×10⁴ cells/cm² of wound area, administered concurrently. Treatment may be terminated earlier or extended based on clinical condition.

Timeline

• Start date: 2018-09-17
• Primary completion: 2027-09-17
• Completion: 2028-09-17
• First posted: 2020-10-19
• Last updated: 2026-03-04

Locations

1 site across 1 country: China