Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University
About this trial
Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Human amniotic-derived mesenchymal stem cells
Biological/Vaccine(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.
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: hAMSC Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Wound Healing
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).
Time frame
Up to 1 year.Secondary outcomes
1
Wound Pain
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).
Time frame
Up to 1 year.2
Measured Quality of Life
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.
Time frame
Up to 1 year.3
Systemic Infection
Assessed by serum hypersensitive C-reactive protein level(hCRP, mg/L). Increased serum hCRP levels above normal ranges indicate infection.
Time frame
Up to 1 year.4
Survival State
Survival time from the hAMSCs treatment started(momths)
Time frame
From date of treatment until the date of die, assessed up to 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Westlake University
Collaborator
Source ClinicalTrials.gov