Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells for Stage 3 and 4 … (NCT06302582) | Clinical Trial Compass
UnknownPhase 1/2
Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells for Stage 3 and 4 Stress Injury
China40 participantsStarted 2024-02-29
Plain-language summary
This study is an open-label, single-center trial which aim to evaluate of efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) combined with platelet-rich plasma (PRP) in stage 3 and 4 stress injury.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-80 years old, regardless of gender;
* Patients with stage 3 and stage 4 pressure injuries (According to National Pressure Ulcer Advisory Panel (NPUAP)/European Pressure Ulcer Advisory Panel (EPUAP) classification system for pressure ulcers);
* There were no complications affecting the wound healing;
* After through debridement for the first time, the wound volume meets the requirement of "10-100cm3"; Platelet count before treatment 100\~300×109/L;
* The patient voluntarily participates and signs an informed consent form.
Exclusion Criteria:
* Individuals with coagulation dysfunction or hemorrhagic diseases;
* People with skin diseases, diabetes and immune diseases;
* Individuals with mental or psychological disorders;
* Individuals with allergies to multiple drugs;
* Pregnant or lactating women;
* Those who need to take medication that affects platelet and coagulation function for a long time or in the near future, but have not stopped taking medication within the past week.
What they're measuring
1
Change From Baseline in Pressure Ulcer Scale for Healing (PUSH)
Timeframe: Baseline,1,2,4 and 6 weeks
2
Change from baseline in Determination of growth factor content