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

NCT05319106 | Recruiting DMC

• 1 other identifier: zsyx1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Leg Ulcer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Healing time

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

  Epithelialization of the wound completely or 24 weeks after treatment

Secondary Outcomes (1)

• Wound shrinkage rate

  Epithelialization of the wound completely or 24 weeks after treatment

Study Arms (2)

Stem cell preparation combined with silver ion dressing

EXPERIMENTAL

Other: stem cell preparation combined with silver ion dressing

silver ion dressing

PLACEBO COMPARATOR

Procedure: silver ion dressing

Interventions

stem cell preparation combined with silver ion dressing OTHER

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.

Stem cell preparation combined with silver ion dressing

silver ion dressing PROCEDURE

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.

silver ion dressing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \&lt; 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).

Sponsors & Collaborators

• ShiCang Yu: lead

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 32636985 RESULT

• 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.

  PMID: 31970660 RESULT

• 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.

  PMID: 34829797 RESULT

• 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.

  PMID: 30775606 RESULT

• 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.

  PMID: 30583949 RESULT

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 8, 2022
• Study Start: December 15, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)