Status:
RECRUITING
Phase Ⅱ Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Venous Leg
Lead Sponsor:
ShiCang Yu
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18-70 years
Phase:
NA
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 an...
Detailed Description
Chronic wounds refer to the pathological changes such as cell senescence, imbalance of synthesis and degradation of extracellular matrix, and decreased activity of growth factors caused by different r...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
December 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT05319106
Start Date
December 15 2022
End Date
March 31 2027
Last Update
March 15 2023
Active Locations (1)
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1
Southwest Hospital, Army Medical University (Third Military Medical University)
Chongqing, Chongqing Municipality, China, 400038