Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells for Stage 3 and 4 Stress Injury

Liaocheng People's Hospital

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Pressure Injuries - Stage 3; Pressure Injuries - Stage 4

Treatments: Biological: Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs); Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06302582

stress injury

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs)

Experimental group

Description:

Inject 3ml PRP+huMSCs (5 × 106) into the edge and bottom of the wound, with 0.5 ml at each point and a distance of approximately 1-3 cm between each point. Then, apply autologous PRP gel (PRP+thrombin mixture, 2ml) evenly on the wound, with a thickness of about 2mm.

Treatment:

Biological: Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs)

Control group

Other group

Description:

Standard therapy

Treatment:

Other: Control group