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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Large Area Burns
• Intervention / Treatment: Procedure: Stem cell preparation combined with Reticular skin; Procedure: Stem cell preparation combined with MEEK skin; Procedure: Stem cell preparation combined with split-thickness skin; Procedure: autologous skin grafting

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Southwest Hospital, Army Medical University (Third Military Medical University)
      • Contact: shicang yu, M.D. and Ph.D.; Phone Number: 023-68766452; Email: yushicang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stem cell preparation combined with Reticular skin	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.
Experimental: Stem cell preparation combined with MEEK 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.
Experimental: Stem cell preparation combined with split-thickness 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.
Placebo Comparator: autologous skin grafting	Procedure: autologous skin grafting; After cleaning the wound, use autologous skin (Reticular skin/MEEK skin/split-thickness skin) grafting and cover the wound surface。

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing rate	(Total area of wound in the operating area - area of unhealed wound)/Total area of wound in the operating area × 100%	On the 21st and 28th days after surgery

Collaborators and Investigators

• Sponsor: ShiCang Yu

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2023
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Estimated): November 8, 2023

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: wound healing; human umbilical cord mesenchymal stem cells; Large area burns
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: zsyx3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No