Clinical trial NCT06302582: Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells for Stage 3 and 4 Stress Injury
Official title: The Efficacy and Safety of Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Patients With Stage 3 and 4 Stress Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Pressure Injuries - Stage 3
Pressure Injuries - Stage 4
Keywords: Mesenchymal stem cells
Platelet rich plasma
Pressure Injuries
Lead sponsor: Liaocheng People's Hospital
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The 2019 edition of the International Guidelines for Clinical Prevention and Treatment of Stress Injury states that stress injury, as a globally prevalent health issue, significantly reduces the quality of life for patients and their families, increases economic burden, and leads to significant expenditure on medical resources. In recent years, the incidence and mortality rate of pressure injuries in hospitalized patients have been increasing year by year. Therefore, there is an urgent need to find a more effective treatment method for pressure injuries in clinical practice. Human umbilical cord mesenchymal stem cells (huMSCs) have immunomodulatory and anti-inflammatory effects. Platelet rich plasma (PRP) can also secrete various nutritional factors, which can effectively promote wound healing. Therefore, the combination of the two may be a more effective treatment method for pressure injuries. At present, there are few reports on the combination of PRP and huMSCs for the treatment of pressure injury. In this study, the investigators aim to evaluate the effectiveness and safety of PRP combined with huMSCs for stage 3 and 4 pressure injuries, In order to promote their clinical application.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Pressure Ulcer Scale for Healing (PUSH)
timeFrame: Baseline,1,2,4 and 6 weeks
measure: Change from baseline in Determination of growth factor content
timeFrame: Baseline,1, 2 and 3 weeks
Secondary outcomes:
measure: Wound healing time
timeFrame: up to 4 months
measure: Positive rate of bacterial culture
timeFrame: Baseline and 2 weeks
Other outcomes:
measure: Safety evaluation
timeFrame: up to 1 week
Locations:
city: Liaocheng
country: China
facility: Central laboratory
state: Shandong
Study officials:
References:
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citation: Wang Y, Luan S, Yuan Z, Wang S, Fan S, Ma C, Wu S. The Combined Use of Platelet-Rich Plasma Clot Releasate and Allogeneic Human Umbilical Cord Mesenchymal Stem Cells Rescue Glucocorticoid-Induced Osteonecrosis of the Femoral Head. Stem Cells Int. 2022 May 2;2022:7432665. doi: 10.1155/2022/7432665. eCollection 2022.