RecruitingNot Applicable

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

China76 participantsStarted 2022-12-15

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

Healing time

Timeframe: Epithelialization of the wound completely or 24 weeks after treatment

Trial details

NCT IDNCT05319106

SponsorShiCang Yu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Venous Leg Ulcer trials