Large Area BurnsNCT06122532
Umbilical Cord Mesenchymal Stem Cells for the Repair of Large Area Burn Wounds
A study testing Stem cell preparation combined with Reticular skin, Stem cell preparation combined with MEEK skin and Stem cell preparation combined with split-thickness skin in people with Large Area Burns, run by ShiCang Yu at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Large Area Burns
- What is being tested?
- Stem cell preparation combined with Reticular skin, Stem cell preparation combined with MEEK skin and Stem cell preparation combined with split-thickness skin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2023to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Selected patients are voluntary and sign an "informed consent form";
- Burn wound area ≥ 20% TBSA, and III ° wound area ≥ 2% TBSA;
- Age range from 18 to 65 years old, regardless of gender;
- Plan to perform two or more limb III degree wounds with scab cutting and autologous skin grafting surgery for treatment;
- No severe heart, lung, blood system, or nervous system diseases;
- There are no clear complications such as systemic infections.
Who cannot join
- Patients who do not agree to participate in this experimental study;
- Age<18 years old or>65 years old;
- Patients with definite malignant tumors, AIDS, diabetes, and autoimmune diseases;
- Pregnant or lactating patients;
- Individuals with systemic dysfunction;
- Patients with acute and chronic liver and kidney diseases;
- Poor compliance makes it difficult to complete the experiment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Southwest Hospital, Army Medical University (Third Military Medical University)
Chongqing, Chongqing Municipality, 400038
shicang yu, M.D. and Ph.D., 023-68766452, yushicang@163.com
About this study
Official title: 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.
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.
- Conditions
- Large Area Burns
- Being tested
- Stem cell preparation combined with Reticular skin, Stem cell preparation combined with MEEK skin, Stem cell preparation combined with split-thickness skin, autologous skin grafting
- Keywords
- Large area burns, human umbilical cord mesenchymal stem cells, wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cell preparation combined with Reticular skinProcedure or surgery
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 skinProcedure or surgery
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 skinProcedure or surgery
The dose of transplanted stem cells per wound (100cm2) is 1 × 10 ^ 6, then cover the wound with autologous split-thickness skin.
autologous skin graftingProcedure or surgery
After cleaning the wound, use autologous skin (Reticular skin/MEEK skin/split-thickness skin) grafting and cover the wound surface。
| Study group | Role | What they receive |
|---|---|---|
| Stem cell preparation combined with Reticular skin | Experimental | Not described Receives: Procedure: Stem cell preparation combined with Reticular skin |
| Stem cell preparation combined with MEEK skin | Experimental | Not described Receives: Procedure: Stem cell preparation combined with MEEK skin |
| Stem cell preparation combined with split-thickness skin | Experimental | Not described Receives: Procedure: Stem cell preparation combined with split-thickness skin |
| autologous skin grafting | Placebo comparator | Not described Receives: Procedure: autologous skin grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing rate
(Total area of wound in the operating area - area of unhealed wound)/Total area of wound in the operating area × 100%
Measured: On the 21st and 28th days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start20 Dec 2023 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Area BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShiCang Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ShiCang Yu, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122532
- Sponsor's protocol ID
- zsyx3
- Status last verified
- Oct 2023
- First submitted
- 2 Nov 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Umbilical Cord Mesenchymal Stem Cells for Wound Repair in Large Area Burn Patients
- ClinicalTrials.gov ID
- NCT06122532
- Acronym / sponsor ID
- zsyx3
- Conditions
- Large Area Burns
- Keywords
- Large area burns, human umbilical cord mesenchymal stem cells, wound healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ShiCang YuUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stem cell preparation combined with Reticular skin | Experimental | Procedure: Stem cell preparation combined with Reticular skin |
| Stem cell preparation combined with MEEK skin | Experimental | Procedure: Stem cell preparation combined with MEEK skin |
| Stem cell preparation combined with split-thickness skin | Experimental | Procedure: Stem cell preparation combined with split-thickness skin |
| autologous skin grafting | Placebo comparator | Procedure: autologous skin grafting |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Selected patients are voluntary and sign an "informed consent form";
- Burn wound area ≥ 20% TBSA, and III ° wound area ≥ 2% TBSA;
- Age range from 18 to 65 years old, regardless of gender;
- Plan to perform two or more limb III degree wounds with scab cutting and autologous skin grafting surgery for treatment;
- No severe heart, lung, blood system, or nervous system diseases;
Key exclusion criteria (7 listed)
- Patients who do not agree to participate in this experimental study;
- Age<18 years old or>65 years old;
- Patients with definite malignant tumors, AIDS, diabetes, and autoimmune diseases;
- Pregnant or lactating patients;
- Individuals with systemic dysfunction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem cell preparation combined with Reticular skinThe dose of transplanted stem cells per wound (100cm2) is 1×10^6, then cover the wound with autologous regular skin. | Procedure or surgery | Stem cell preparation combined with Reticular skin |
| Stem cell preparation combined with MEEK skinThe dose of transplanted stem cells per wound (100cm2) is 1 × 10 ^ 6, then cover the wound with autologous MEEK skin. | Procedure or surgery | Stem cell preparation combined with MEEK skin |
| Stem cell preparation combined with split-thickness skinThe dose of transplanted stem cells per wound (100cm2) is 1 × 10 ^ 6, then cover the wound with autologous split-thickness skin. | Procedure or surgery | Stem cell preparation combined with split-thickness skin |
| autologous skin graftingAfter cleaning the wound, use autologous skin (Reticular skin/MEEK skin/split-thickness skin) grafting and cover the wound surface。 | Procedure or surgery | autologous skin grafting |
Primary outcome
Wound healing rate
Time frame: On the 21st and 28th days after surgery
(Total area of wound in the operating area - area of unhealed wound)/Total area of wound in the operating area × 100%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Large Area Burns
Recruiting
Field Shield Wound Dressing Study
Burn Wounds - Partial Thickness (2nd Degree)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Southwest Hospital, Army Medical University (Third Military Medical University)
Chongqing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stem cell preparation combined with Reticular skin, Stem cell preparation combined with MEEK skin and Stem cell preparation combined with split-thickness skin in people with Large Area Burns, run by ShiCang Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing rate (time frame: On the 21st and 28th days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.