Mesenchymal Stem Cells in the Treatment of Burn Wounds
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Xinxiang Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary participation and signing of the informed consent form;
Burn patients, subjects 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;
Disqualifiers
Those allergic to sodium alginate (gel component);
Electric shock injuries, chemical burns, radiation injuries or combined with other traumas;
Subjects with severe systemic diseases (judged by the researchers);
Subjects with uncontrolled hypertension or diabetes (judged by the researchers);
Trial design
Design model
Parallel
Treatments tested in this trial
low-dose stem cell gel group
Combination productUsing hydrogels containing low-doses of placenta-derived mesenchymal stem cells as wound dressings to promote wound healing in burn patients after thick skin grafting
high-dose stem cell gel group
Combination productUsing hydrogels containing or without differenthigh-doses of placenta-derived mesenchymal stem cells as wound dressings to promote wound healing in burn patients after thick skin grafting
with only the gel
Other interventionUsing only hydrogels as wound dressings to promote wound healing in burn patients after thick skin grafting
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: low-dose stem cell gel groupExperimental treatment 1 intervention
Group B: high-dose stem cell gel groupExperimental treatment 1 intervention
Group C: with only the gelPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Re-epithelialization areas
Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs
Time frame
Up to 6 month2
Complete burn wound healing
Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs
Time frame
Up to 12 monthSponsors and contacts
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Source ClinicalTrials.gov