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Clinical Trials in China / NCT05319106
Recruiting Not applicable

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

NCT05319106 · tracked via the Priya Life Science China tracker
Sponsor
ShiCang Yu
Phase
Not applicable
Started
2022-12-15
Last updated
2023-03-15

Condition(s) studied

Venous Leg Ulcer

Investigational drug(s) / intervention(s)

stem cell preparation combined with silver ion dressingsilver ion dressing

stem cell preparation combined with silver ion dressing: 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: 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 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Southwest Hospital, Army Medical University (Third Military Medical University) Chongqing Chongqing Municipality Recruiting

More ShiCang Yu trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05319106 on ClinicalTrials.gov ↗ ← All trials in China