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.
Study summary
Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Wound Healing — Up to 1 year. The Bates-Jensen Wound Assessment (BWAT) is a standardized tool for quantitative assessment of wound healing that includes the 13 items listed below: (1)Size; (2)Depth; (3)Edges; (4)Undermining or pockets; (5)Necrotic tissue type; (6)Necrotic tissue amount; (7)Exudate type; (8)Exudate amount; (9)Surrounding skin color; (10)Peripheral tissue edema; (11)Peripheral tissue induration; (12)Granulation tissue; (13)Epithelialization.
Each item was rated on a scale of 1 (best) to 5 (worst). The BWAT total score is the sum of the individual items with a possible range of 13 (best) to 65 (worst).
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital
Nanjing
Jiangsu
Recruiting
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.