NCT06122532

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

Clinical Study on Umbilical Cord Mesenchymal Stem Cells for Wound Repair in Large Area Burn Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: ShiCang Yu · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2023-12-20
• Primary completion: 2028-10-30
• Completion: 2028-10-30
• First posted: 2023-11-08
• Last updated: 2023-11-08

Locations

1 site across 1 country: China