RecruitingEarly Phase 1NCT04592640

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


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

9 participants

Start Date

Sep 17, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether stem cells derived from human amniotic tissue (material from the placenta) can treat calciphylaxis — a rare and extremely painful condition where calcium deposits form inside small blood vessels, causing severe skin wounds and ulcers that are very difficult to heal. It mainly affects people with chronic kidney disease or those on dialysis, and current treatments are limited. **You may be eligible if...** - You are between 18 and 75 years old - You have been clinically diagnosed with calciphylaxis - You have chronic kidney disease, whether or not you are on dialysis (hemodialysis or peritoneal dialysis) - You have signed informed consent **You may NOT be eligible if...** - You have an active cancer or severe psychiatric disorder - Your expected survival is less than 6 months - You are pregnant or breastfeeding - You participated in another experimental drug trial within the last 90 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHuman 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.


Locations(1)

The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital

Nanjing, Jiangsu, China

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NCT04592640


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