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

Venous Leg Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05319106
• Other study ID #: zsyx1
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2023
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: March 31, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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.

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.

Locations

Country	Name	City	State
China	Southwest Hospital, Army Medical University (Third Military Medical University)	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
ShiCang Yu

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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):200-2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing time	The time required for the wound healing rate to reach 100%	Epithelialization of the wound completely or 24 weeks after treatment
Secondary	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%	Epithelialization of the wound completely or 24 weeks after treatment