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

Recruiting now · Not applicable

Conditions studied: Venous Leg Ulcer

In brief

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 facts

Study ID: NCT05319106
Run by: ShiCang Yu
People needed: 76
Starts: 2022-12-15
Expected to finish: 2027-03-31
Last updated by the study team: 2023-03-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age from 18 to 70, no gender limitation;
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.
Participate in the clinical study voluntarily, observe the study procedure, and observe the curative effect cooperatively.

You may not qualify if…

Pregnant or lactation women; Women who have planned to have children recently (within 6 months);
Patients with peripheral artery disease with ankle-brachial index (ABI) < 0.8;
Patients with active clinical systemic infection;
Serious skin wound infection is not under control;
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 \< Normal 30%) and severely impaired hematopoietic function;
Abnormal coagulation function or current anticoagulant treatment;
Systemic autoimmune diseases in the active stage;
With systemic organ or hematological malignancy;
PERSONS infected with HIV or addicted to drugs, tobacco and alcohol;
Have a clear history of mental illness;
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).

Where it is running

Southwest Hospital, Army Medical University (Third Military Medical University) — Chongqing, Chongqing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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