Umbilical Cord Mesenchymal Stem Cells for the Repair of Large Area Burn Wounds

NCT ID: NCT06122532

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2028-10-30

Brief Summary

This study intends to adopt a prospective, open, and randomized controlled research method to explore the effectiveness and safety of using human umbilical cord mesenchymal stem cells to treat large-scale burn wounds, in order to break through the limitations of various current treatment methods, explore new clinical treatment methods, promote the repair and healing of skin lesions, and further improve the cure rate and quality of life of patients.

Detailed Description

Large area deep burn patients, due to extensive skin defects in their limbs that cannot be repaired by the body itself, need to undergo skin grafting surgery to seal the wound. Although skin transplantation can partially meet the needs of wound sealing, the skin scar hyperplasia after transplantation and healing is significant, affecting the appearance and motor function of the limbs. Moreover, the healed skin lacks dermal tissue and sweat glands and other skin accessories, resulting in poor skin quality after wound healing, And accompanied by obvious discomfort such as fear of heat, itching, and pain, which seriously affects the patient's quality of life. Mesenchymal stem cells have high differentiation potential and can differentiate across embryonic boundaries into epithelial tissue cells such as skin. They can also secrete various cytokines to produce chemotactic and anti apoptotic effects, promoting the formation of wound neovascularization and wound healing. Human umbilical cord mesenchymal stem cells, due to their convenient and painless source, have become good seed cells for promoting wound healing.

Conditions

Large Area Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stem cell preparation combined with Reticular skin

Group Type: EXPERIMENTAL

Stem cell preparation combined with Reticular skin

Intervention Type: PROCEDURE

The dose of transplanted stem cells per wound (100cm2) is 1×10\^6, then cover the wound with autologous regular skin.

Stem cell preparation combined with MEEK skin

Group Type: EXPERIMENTAL

Stem cell preparation combined with MEEK skin

Intervention Type: PROCEDURE

The dose of transplanted stem cells per wound (100cm2) is 1 × 10 \^ 6, then cover the wound with autologous MEEK skin.

Stem cell preparation combined with split-thickness skin

Group Type: EXPERIMENTAL

Stem cell preparation combined with split-thickness skin

Intervention Type: PROCEDURE

The dose of transplanted stem cells per wound (100cm2) is 1 × 10 \^ 6, then cover the wound with autologous split-thickness skin.

autologous skin grafting

Group Type: PLACEBO_COMPARATOR

autologous skin grafting

Intervention Type: PROCEDURE

After cleaning the wound, use autologous skin (Reticular skin/MEEK skin/split-thickness skin) grafting and cover the wound surface。

Interventions

Stem cell preparation combined with Reticular skin

The dose of transplanted stem cells per wound (100cm2) is 1×10\^6, then cover the wound with autologous regular skin.

Intervention Type: PROCEDURE

Stem cell preparation combined with MEEK skin

The dose of transplanted stem cells per wound (100cm2) is 1 × 10 \^ 6, then cover the wound with autologous MEEK skin.

Intervention Type: PROCEDURE

Stem cell preparation combined with split-thickness skin

The dose of transplanted stem cells per wound (100cm2) is 1 × 10 \^ 6, then cover the wound with autologous split-thickness skin.

Intervention Type: PROCEDURE

autologous skin grafting

After cleaning the wound, use autologous skin (Reticular skin/MEEK skin/split-thickness skin) grafting and cover the wound surface。

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Selected patients are voluntary and sign an "informed consent form";

2. Burn wound area ≥ 20% TBSA, and III ° wound area ≥ 2% TBSA;

3. Age range from 18 to 65 years old, regardless of gender;

4. Plan to perform two or more limb III degree wounds with scab cutting and autologous skin grafting surgery for treatment;

5. No severe heart, lung, blood system, or nervous system diseases;

6. There are no clear complications such as systemic infections.

Exclusion Criteria

1. Patients who do not agree to participate in this experimental study;

2. Age<18 years old or>65 years old;

3. Patients with definite malignant tumors, AIDS, diabetes, and autoimmune diseases;

4. Pregnant or lactating patients;

5. Individuals with systemic dysfunction;

6. Patients with acute and chronic liver and kidney diseases;

7. Poor compliance makes it difficult to complete the experiment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ShiCang Yu

OTHER

Sponsor Role: lead

Responsible Party

ShiCang Yu

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Chongqing, Chongqing Municipality, China

Countries

China

Facility Contacts

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

Role: primary

yushicang@163.com

023-68766452

Other Identifiers

zsyx3

Identifier Type: -

Identifier Source: org_study_id