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Recruiting NCT05319106

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

Trial Parameters

Condition Venous Leg Ulcer
Sponsor ShiCang Yu
Study Type INTERVENTIONAL
Phase N/A
Enrollment 76
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2022-12-15
Completion 2026-06-30
Interventions
stem cell preparation combined with silver ion dressingsilver ion dressing

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Age from 18 to 70, no gender limitation; 2. It met the diagnostic criteria of venous ulcer of lower limbs in Clinical Vascular Surgery (5th edition), and the following conditions were met: the ulcer lasted for more than 1 month; The wound area was between 10cm2 and 40cm2. Wound depth: All wounds were deep tissue ulcers below the epidermis. 3. Participate in the clinical study voluntarily, observe the study procedure, and observe the curative effect cooperatively. Exclusion Criteria: 1. Pregnant or lactation women; Women who have planned to have children recently (within 6 months); 2. Patients with peripheral artery disease with ankle-brachial index (ABI) \< 0.8; 3. Patients with active clinical systemic infection; 4. Serious skin wound infection is not under control; 5. low immune function and systemic failure; Severe heart, liver, lung, kidney and other important organ lesions (ALT, AST, Cr \& GT; Normal 1.5 times, congestive heart failure ejection fraction \&lt

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