Using stem cells to treat venous leg ulcers

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

This study is testing if using stem cells from umbilical cords along with a special dressing can help heal stubborn leg ulcers better than just using the dressing alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Southwest Hospital, China (other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT05319106 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of local transplantation of human umbilical cord mesenchymal stem cells combined with silver ion dressing compared to silver ion dressing alone in treating venous leg ulcers. The study aims to improve the healing rate and quality of life for patients suffering from chronic wounds that have not healed after conventional treatments. Participants will be monitored for their wound healing progress over the course of the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with venous leg ulcers that have persisted for more than one month and meet specific wound size and depth criteria.

Not a fit: Patients with peripheral artery disease, active infections, or severe organ dysfunction may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this approach could significantly enhance wound healing and improve the quality of life for patients with venous leg ulcers.

How similar studies have performed: While the use of stem cells in wound healing is a growing area of interest, this specific combination approach is relatively novel and has not been extensively tested in prior studies.

Eligibility 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).

Where this trial is running

Chongqing, Chongqing Municipality

• Southwest Hospital, Army Medical University (Third Military Medical University) — Chongqing, Chongqing Municipality, China (RECRUITING)

Conditions: Venous Leg Ulcer, Venous leg ulcer, human umbilical cord mesenchymal stem cells, wound healing