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

Primary Purpose

Venous Leg Ulcer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

stem cell preparation combined with silver ion dressing

silver ion dressing

About this trial

This is an interventional treatment trial for Venous Leg Ulcer focused on measuring Venous leg ulcer, human umbilical cord mesenchymal stem cells, wound healing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;
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).

Sites / Locations

Southwest Hospital, Army Medical University (Third Military Medical University)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Stem cell preparation combined with silver ion dressing

silver ion dressing

Arm Description

Outcomes

Primary Outcome Measures

Healing time

The time required for the wound healing rate to reach 100%

Secondary Outcome Measures

Wound shrinkage rate

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%

Full Information

NCT ID

NCT05319106

First Posted

March 18, 2022

Last Updated

March 13, 2023

Sponsor

ShiCang Yu

1. Study Identification

Unique Protocol Identification Number

NCT05319106

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 15, 2022 (Actual)

Primary Completion Date

June 30, 2026 (Anticipated)

Study Completion Date

March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

ShiCang Yu

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Leg Ulcer

Keywords

Venous leg ulcer, human umbilical cord mesenchymal stem cells, wound healing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stem cell preparation combined with silver ion dressing

Arm Type

Experimental

Arm Title

silver ion dressing

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

stem cell preparation combined with silver ion dressing

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

silver ion dressing

Intervention Description

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.

Primary Outcome Measure Information:

Title

Healing time

Description

The time required for the wound healing rate to reach 100%

Time Frame

Epithelialization of the wound completely or 24 weeks after treatment

Secondary Outcome Measure Information:

Title

Wound shrinkage rate

Description

Time Frame

Epithelialization of the wound completely or 24 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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; 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).

Facility Information:

Facility Name

Southwest Hospital, Army Medical University (Third Military Medical University)

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400038

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

shicang yu, M.D. and Ph.D.

Phone

023-68766452

yushicang@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32636985

Citation

Alvarez OM, Markowitz L, Parker R, Wendelken ME. Faster Healing and a Lower Rate of Recurrence of Venous Ulcers Treated With Intermittent Pneumatic Compression: Results of a Randomized Controlled Trial. Eplasty. 2020 Jun 5;20:e6. eCollection 2020.

Results Reference

result

PubMed Identifier

31970660

Citation

Nicolaides AN. The Most Severe Stage of Chronic Venous Disease: An Update on the Management of Patients with Venous Leg Ulcers. Adv Ther. 2020 Feb;37(Suppl 1):19-24. doi: 10.1007/s12325-020-01219-y. Epub 2020 Jan 22.

Results Reference

result

PubMed Identifier

34829797

Citation

Aleksandrowicz H, Owczarczyk-Saczonek A, Placek W. Venous Leg Ulcers: Advanced Therapies and New Technologies. Biomedicines. 2021 Oct 29;9(11):1569. doi: 10.3390/biomedicines9111569.

Results Reference

result

PubMed Identifier

30775606

Citation

Kavala AA, Turkyilmaz S. Autogenously derived regenerative cell therapy for venous leg ulcers. Arch Med Sci Atheroscler Dis. 2018 Dec 15;3:e156-e163. doi: 10.5114/amsad.2018.81000. eCollection 2018.

Results Reference

result

PubMed Identifier

30583949

Citation

Zollino I, Campioni D, Sibilla MG, Tessari M, Malagoni AM, Zamboni P. A phase II randomized clinical trial for the treatment of recalcitrant chronic leg ulcers using centrifuged adipose tissue containing progenitor cells. Cytotherapy. 2019 Feb;21(2):200-211. doi: 10.1016/j.jcyt.2018.10.012. Epub 2018 Dec 22.

Results Reference

result

Learn more about this trial

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

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