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NCT Number: NCT04592640

Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis

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

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Key information

Conditions

Chronic Kidney Diseases Calcific Uremic Arteriolopathy Calcinosis Calciphylaxis Calcium Metabolism Disorders Chronic Disease Disease Attributes Efficacy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Renal Insufficiency Renal Insufficiency, Chronic Safety Treatment Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

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, anticoagulant and aggressive treatment of predisposing conditions. Drugs such as sodium thiosulfate(STS), bisphosphonate, SNF472 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 calciphylaxis patients with human amniotic-derived mesenchymal stem cells (hAMSCs).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Human amniotic-derived mesenchymal stem cells

Biological

(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.

Primary outcomes

  1. Wound Healing

    Time frame: 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).

Secondary outcomes

  1. Wound Pain

    Time frame: Up to 1 year.

    Assessed by pain visual analog scale (VAS). VAS Score is a horizontal line, 100 mm in length, anchored by word descriptors at each end. The subject marked the point on the line that represented his/her perception of his/her current pain status. VAS Score was determined by measuring in millimeters from the left hand end of the line (no pain) to the point that the subject marked. VAS Score range 0 (best) to 100 (Worst).

  2. Measured Quality of Life

    Time frame: Up to 1 year.

    The wound-quality of life(QoL) questionnaire measures the disease-specific, health related QoL of patients with chronic wounds. It consists of 17 items on impairments that are assessed in retrospect to the preceding 7 days and rated on a 0 (best) to 4 (worse) scale with possible responses from "not at all" to "very much". The total score is the average of the 17 responses.

  3. Systemic Infection

    Time frame: Up to 1 year.

    Assessed by serum hypersensitive C-reactive protein level(hCRP, mg/L). Increased serum hCRP levels above normal ranges indicate infection.

  4. Survival State

    Time frame: From date of treatment until the date of die, assessed up to 1 year.

    Survival time from the hAMSCs treatment started(momths)

Study contacts

Contact information is provided by the study sponsor or research team.

Lianju Qin, Professor

CONTACT

[email protected]

86-018012923584

Ningning Wang, Professor

CONTACT

[email protected]

86-013813821064 ext. +8613813821064

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Westlake University

Registry information

Official study title

Effects of Human Amniotic-derived Mesenchymal Stem Cells (hAMSCs) on Calciphylaxis Patients: An Open-Label Single-Arm Study

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Oct 19, 2020
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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