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Not yet recruitingNCT06122532Updated Nov 8, 2023

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

An interventional study of Stem cell preparation combined with Reticular skin and Stem cell preparation combined with MEEK skin in Large Area Burns, sponsored by ShiCang Yu. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-08.

Sponsored by ShiCang Yu · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Large Area Burns

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Keywords

  • Large area burns
  • human umbilical cord mesenchymal stem cells
  • wound healing
03

In context

Burns

720 studies on the registry are indexed under Burns; 146 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 525 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

ShiCang Yu is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Stem cell preparation combined with Reticular skin

    Procedure: Stem cell preparation combined with Reticular skin

  • Experimental
    Stem cell preparation combined with MEEK skin

    Procedure: Stem cell preparation combined with MEEK skin

  • Experimental
    Stem cell preparation combined with split-thickness skin

    Procedure: Stem cell preparation combined with split-thickness skin

  • Placebo comparator
    autologous skin grafting

    Procedure: autologous skin grafting

Interventions

  • ProcedureStem 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.

  • ProcedureStem 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.

  • ProcedureStem 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.

  • Procedureautologous skin grafting

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

06

What researchers measure

Primary outcomes

  1. Wound healing rate

    (Total area of wound in the operating area - area of unhealed wound)/Total area of wound in the operating area × 100%

    Time frame: On the 21st and 28th days after surgery

07

Study locations

1 site
  • Southwest Hospital, Army Medical University (Third Military Medical University)
    Chongqing, Chongqing 400038, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06122532
Lead sponsor
ShiCang Yu
Responsible party
ShiCang Yu (Director, Southwest Hospital, China) — Sponsor-investigator
First posted
Nov 8, 2023
Start date
Dec 20, 2023 (estimated)
Primary completion
Oct 30, 2028 (estimated)
Completion
Oct 30, 2028 (estimated)
Last update
Nov 8, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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