Phase Ⅱ Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Venous Leg

Sponsor
ShiCang Yu
Study ID
NCT05319106
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • stem cell preparation combined with silver ion dressing — OTHER
    The dosage range of each cm2 ulcer wound is (1～5)×10\^6. The dosage of human umbilical cord mesenchymal stem cells for the second treatment is determined according to the severity of the ulcer. Each patient is treated for 2 consecutive times, and the interval between each treatment is 3 days.
  • silver ion dressing — PROCEDURE
    fter wound debridement, a silver ion dressing suitable for the size of the wound was cut and covered on the wound bed. Sterile gauze was covered on the silver ion dressing and fixed with adhesive tape.

Study Details

This project adopts a prospective clinical trial study to compare and evaluate the efficacy of local transplantation of human umbilical cord mesenchymal stem cells combined with silver ion dressing and simple silver ion dressing in the treatment of venous lower extremity ulcer wounds. To improve the healing rate and quality of life of patients.

Key Dates

First listed
Apr 8, 2022
Start date
Dec 15, 2022
Status verified
Mar 2023
Primary completion
Jun 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stem cell preparation combined with silver ion dressing
  • Placebo Comparator: silver ion dressing

Primary Outcome Measure

Healing time [ Time Frame: Epithelialization of the wound completely or 24 weeks after treatment ]

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