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New treatment option for Burn Injury
Official title Mesenchymal Stem Cells in the Treatment of Burn Wounds
ClinicalTrials.gov ID: NCT07580755
What this study is testing
What is low-dose stem cell gel group?
low-dose stem cell gel group is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for burn injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Burn patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), and received the same treatment under the same conditions simultaneously.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Voluntary participation and signing of the informed consent form;
- Burn patients, people requiring autologous skin grafting;
- Age 18 to 65 years old, gender not restricted;
- During this clinical study, single person, single donor skin area (lateral thigh or trunk) treatment;
- Skin burn area \< 30% of total body surface area (TBSA);
You likely can't join if
- Those allergic to sodium alginate (gel component);
- Electric shock injuries, chemical burns, radiation injuries or combined with other traumas;
- people with severe systemic diseases (judged by the researchers);
- people with uncontrolled hypertension or diabetes (judged by the researchers);
- Pregnant or lactating women;
- people whose condition may affect the study assessment or require the concurrent use of medical treatments that may affect the how well it works...
See the full eligibility criteria
- Voluntary participation and signing of the informed consent form;
- Burn patients, people requiring autologous skin grafting;
- Age 18 to 65 years old, gender not restricted;
- During this clinical study, single person, single donor skin area (lateral thigh or trunk) treatment;
- Skin burn area \< 30% of total body surface area (TBSA);
- The donor skin area is the first time for donation, and the donor skin area is medium-thick skin (thickness approximately 0.4mm);
- The area of the excised skin flap ≥ 90 cm2;
- Able to cooperate with this study protocol and accept regular postoperative follow-up visits.
- Those allergic to sodium alginate (gel component);
- Electric shock injuries, chemical burns, radiation injuries or combined with other traumas;
- people with severe systemic diseases (judged by the researchers);
- people with uncontrolled hypertension or diabetes (judged by the researchers);
- Pregnant or lactating women;
- people whose condition may affect the study assessment or require the concurrent use of medical treatments that may affect the how well it works assessment;
- people with acute or chronic kidney diseases, renal failure or serum creatinine level = 1.5 times the upper limit of normal value;
- people with acute or chronic liver diseases, total bilirubin, alanine aminotransferase, aspartate aminotransferase = 2.0 times the upper limit of normal value;
- people with a history of malignant tumors;
- people who have participated in other clinical studies for less than 3 months;
- people with mental disorders and without self-awareness, unable to express clearly;
- people using immunosuppressants and those who have been using corticosteroids for a long time (more than 1 month) (excluding local application);
- people with infectious diseases (any one of the four items positive in the test);
- people with other severe systemic diseases;
- Other people that the researchers consider not eligible for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Xinxiang, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xinxiang, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.