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
The First Affiliated Hospital with Nanjing Medical University
9 participants
Sep 17, 2018
INTERVENTIONAL
Conditions
Summary
Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells
Eligibility
Inclusion Criteria3
- years old.
- Clinical diagnosis of calciphylaxis, including patients with chronic kidney disease who did not or had regular dialysis (hemodialysis or peritoneal dialysis).
- All subjects signed informed consent.
Exclusion Criteria4
- Patients who refuse to sign informed consent.
- Patients with malignant tumors or severe psychiatric disorders, or an expected survival time of less than 6 months.
- Pregnant or lactating women of childbearing age.
- Participation in another clinical trial with an experimental drug within 90 days prior the inclusion.
Interventions
(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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04592640