Stem Cells for Uremic Calciphylaxis Patients

Ningning Wang

Status: Active, not recruiting

Conditions: Chronic Kidney Diseases; Calcific Uremic Arteriolopathy; Treatment; Calciphylaxis

Treatments: Other: Human amniotic mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04592640

Stem cell

Details and patient eligibility

About

Treatment for Uremic Calciphylaxis Patients with Human Amniotic Mesenchymal Stem Cells

Full 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 and aggressive treatment of predisposing conditions. Drugs such as sodium thiosulfate, bisphosphonate, 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 uremic calciphylaxis patients with human amniotic mesenchymal stem cells (hAMSCs).

Enrollment: 7 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-60 years old.
2. Patients with chronic kidney disease who did not or had regular dialysis (hemodialysis or peritoneal dialysis).
3. Clinical diagnosis of calciphylaxis.
4. All subjects signed informed consent.

Exclusion criteria

1. Patients who refuse to sign informed consent.
2. Patients with malignant tumor or serious mental disease, cardiovascular disease, shock, abnormal liver function and secondary kidney disease.
3. Pregnant or lactating women of childbearing age.
4. Participation in another clinical trial with an experimental drug within 90 days prior the inclusion.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Uremic Calciphylaxis Patients

Experimental group

Description:

Human amniotic mesenchymal stem cells (hAMSCs)

Treatment:

Other: Human amniotic mesenchymal stem cells