Effects of Human Amniotic-derived Mesenchymal Stem Cells (hAMSCs) on Calciphylaxis Patients: An Open-Label Single-Arm Study
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 18-75 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.
Locations
Other Locations
China
The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital
RECRUITING
Nanjing
Contact Information
Primary
Ningning Wang, Professor
wangnn@njmu.edu.cn
86-013813821064
Backup
Lianju Qin, Professor
ljqin@njmu.edu.cn
86-018012923584
Time Frame
Start Date: 2018-09-17
Estimated Completion Date: 2028-09-17
Participants
Target number of participants: 9
Treatments
Experimental: hAMSC Treatment Group
hAMSC treatment regimen: (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.
Related Therapeutic Areas
Sponsors
Collaborators: Westlake University
Leads: The First Affiliated Hospital with Nanjing Medical University