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

Launched by SHICANG YU · Mar 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for venous leg ulcers, which are painful wounds that can occur on the lower legs due to poor blood circulation. Researchers want to see if using special cells from human umbilical cords, combined with silver dressings, can help these wounds heal better than just using silver dressings alone. The goal is to improve healing rates and enhance the quality of life for patients suffering from these ulcers.

To participate in the trial, individuals must be between the ages of 18 and 70 and have a venous leg ulcer that has lasted for more than a month, with a wound size between 10 and 40 square centimeters. Participants will receive treatment and will be closely monitored throughout the study. It’s important to note that some individuals, such as those with certain health conditions or those who are pregnant, may not be eligible to join. If you or someone you know is interested in this trial, it’s a great opportunity to contribute to new treatments that could benefit many patients in the future.

Gender

ALL

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; Normal 30%) and severely impaired hematopoietic function;
• • 6. Abnormal coagulation function or current anticoagulant treatment;
• • 7. Systemic autoimmune diseases in the active stage;
• • 8. With systemic organ or hematological malignancy;
• • 9. PERSONS infected with HIV or addicted to drugs, tobacco and alcohol;
• • 10. Have a clear history of mental illness;
• • 11. Participation in clinical studies of any drug within 1 month prior to treatment (or the 5 half-life of the investigational drug, whichever is longer).