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Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis

Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis

Recruiting
18-75 years
All
Phase 0

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Overview

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

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).

Eligibility

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.

Study details
    Chronic Kidney Diseases
    Calciphylaxis
    Calcific Uremic Arteriolopathy
    Treatment
    Safety
    Efficacy

NCT04592640

The First Affiliated Hospital with Nanjing Medical University

13 May 2026

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