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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-11-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pressure Injuries - Stage 3 Pressure Injuries - Stage 4

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

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

Control group

Standard therapy

Group Type OTHER

Control group

Intervention Type OTHER

Standard therapy for patients with stage 3 and 4 stress injury

Interventions

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

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

Intervention Type BIOLOGICAL

Control group

Standard therapy for patients with stage 3 and 4 stress injury

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No