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

March 13, 2023 updated by: ShiCang Yu

Transplantation of Human Umbilical Cord Derived Mesenchymal Stem Cell for Refractory Skin Ulcer Therapy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 reasons when the wound is prolonged and does not heal after conventional treatment for more than 1 month without healing tendency. Chronic wound can be caused by a variety of diseases, including arterial disease, diabetes, vasculitis, venous disease and skin malignant tumor, chronic venous insufficiency (CVI) is a disease leading to chronic wound, Venous ulcer (VLU) of lower limbs is the advanced manifestation of CVI, and the incidence of this disease ranges from 0.4% to 1.3% in China. 60% of VLU patients' ulcer wounds heal in 3-6 months, 33% in 12 months, and 7% May be permanently unhealed. The probability of recurrence is as high as 70% in patients 3-5 months after wound healing, which not only seriously affects the health and quality of life of patients, but also causes a very heavy social medical burden. At present, the conventional treatment for VLU mainly includes drug therapy, stress therapy, wound treatment and surgical treatment, but the therapeutic effect is not ideal.

Study Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Southwest Hospital, Army Medical University (Third Military Medical University)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 < 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stem cell preparation combined with silver ion dressing
Other: 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.
Placebo Comparator: silver ion dressing
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing time
Time Frame: Epithelialization of the wound completely or 24 weeks after treatment
The time required for the wound healing rate to reach 100%
Epithelialization of the wound completely or 24 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound shrinkage rate
Time Frame: Epithelialization of the wound completely or 24 weeks after treatment

Grid method was used to calculate the wound area, with 1 decimal place behind the length unit and 2 decimal places behind the area unit. The wound edges before, during and after treatment were depicted on the transparent mesh film respectively, and the original wound area and the unhealed wound area were calculated.

Wound shrinkage rate = (initial area of wound - area measured on the day)/original area of wound × 100%
Epithelialization of the wound completely or 24 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ShiCang Yu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Anticipated)

June 30, 2026

Study Completion (Anticipated)

March 31, 2027

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 31, 2022

First Posted (Actual)

April 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zsyx1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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