Stem cell gel could speed burn healing in new trial
NCT ID NCT07580755
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a gel made from umbilical cord stem cells can help heal severe burns faster and more safely. About 90 adults with burns covering less than 30% of their body will receive either a low-dose, high-dose, or placebo gel on their donor skin site. The main goal is to see how quickly the skin grows back and fully heals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntary participation and signing of the informed consent form; 2. Burn patients, subjects requiring autologous skin grafting; 3. Age 18 to 65 years old, gender not restricted; 4. During this clinical study, single person, single donor skin area (lateral thigh or trunk) treatment; 5. Skin burn area \< 30% of total body surface area (TBSA); 6. The donor skin area is the first time for donation, and the donor skin area is medium-thick skin (thickness approximately 0.4mm); 7. The area of the excised skin flap ≥ 90 cm2; 8. Able to cooperate with this study protocol and accept regular postoperative follow-up visits. Exclusion Criteria: 1. Those allergic to sodium alginate (gel component); 2. Electric shock injuries, chemical burns, radiation injuries or combined with other traumas; 3. Subjects with severe systemic diseases (judged by the researchers); 4. Subjects with uncontrolled hypertension or diabetes (judged by the researchers); 5. Pregnant or lactating women; 6. Subjects whose condition may affect the study assessment or require the concurrent use of medical treatments that may affect the efficacy assessment; 7. Subjects with acute or chronic kidney diseases, renal failure or serum creatinine level = 1.5 times the upper limit of normal value; 8. Subjects with acute or chronic liver diseases, total bilirubin, alanine aminotransferase, aspartate aminotransferase = 2.0 times the upper limit of normal value; 9. Subjects with a history of malignant tumors; 10. Subjects who have participated in other clinical studies for less than 3 months; 11. Subjects with mental disorders and without self-awareness, unable to express clearly; 12. Subjects using immunosuppressants and those who have been using corticosteroids for a long time (more than 1 month) (excluding local application); 13. Subjects with infectious diseases (any one of the four items positive in the test); 14. Subjects with other severe systemic diseases; 15. Other subjects that the researchers consider not eligible for inclusion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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The First Affiliated Hospital of Xinxiang Medical College
RECRUITINGXinxiang, Henan, 453000, China
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