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

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ClinicalTrials.gov Identifier: NCT05319106
Recruitment Status : Recruiting
First Posted : April 8, 2022
Last Update Posted : April 8, 2022
Sponsor:
Information provided by (Responsible Party):
ShiCang Yu, Southwest Hospital, China

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 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.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Other: stem cell preparation combined with silver ion dressing Procedure: silver ion dressing Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transplantation of Human Umbilical Cord Derived Mesenchymal Stem Cell for Refractory Skin Ulcer Therapy
Estimated Study Start Date : April 1, 2022
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : March 31, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental group
Local transplantation stem cell preparation combined with 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.

Placebo Comparator: control group
Local trantment 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.




Primary Outcome Measures :
  1. Healing time [ Time Frame: Epithelialization of the wound completely or 24 weeks after treatment ]
    the time required for complete epithelialization of the wound by visual observation, and the of days when the wound healing rate reaches 100%


Secondary Outcome Measures :
  1. 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%




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05319106


Locations
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China, Chongqing
Southwest Hospital, Army Medical University (Third Military Medical University) Recruiting
Chongqing, Chongqing, China, 400038
Contact: shicang yu, M.D. and Ph.D.    13228685391    yushicang@163.com   
Sponsors and Collaborators
ShiCang Yu
Publications of Results:
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Responsible Party: ShiCang Yu, chief physician, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT05319106    
Other Study ID Numbers: zsyx1
First Posted: April 8, 2022    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ShiCang Yu, Southwest Hospital, China:
Venous leg ulcer
human umbilical cord mesenchymal stem cells
wound healing
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases