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

March 7, 2024 updated by: Liaocheng People's Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: 1966-03-07

Study Locations

  • China
    • Shandong
      • Liaocheng, Shandong, China, 252000
        • Recruiting
        • Central laboratory
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Biological: 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
Other: Control group
Standard therapy
Other: Control group
Standard therapy for patients with stage 3 and 4 stress injury

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pressure Ulcer Scale for Healing (PUSH)
Time Frame: Baseline,1,2,4 and 6 weeks
The scale includes three dimensions: wound area, exudate volume, and tissue type. The total score of the three dimensions was indicated the healing of pressure injury and ranged from 0 to 17 points, with 0 points indicating wound healing. The PUSH score decreased, indicating improvement. The total score increased, indicating deterioration. Multiple pressure injuries in the same patient were evaluated separately.
Baseline,1,2,4 and 6 weeks
Change from baseline in Determination of growth factor content
Time Frame: Baseline,1, 2 and 3 weeks
Serum epidermal growth factor (EGF) and vascular endothelial growth factor (VEGF) were detected during treatment.
Baseline,1, 2 and 3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wound healing time
Time Frame: up to 4 months
The wound healing standard is wound closure and epithelial tissue coverage, and the wound healing time refers to the time from the date of direct treatment to wound healing for the patient. The wound healing time was recorded through dressing change in outpatient department or phone call follow-up.
up to 4 months
Positive rate of bacterial culture
Time Frame: Baseline and 2 weeks
The patient's wound secretions were collected for bacterial culture on the day of stem cell treatment and 2 weeks after treatment.
Baseline and 2 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety evaluation
Time Frame: up to 1 week
Any adverse events that occur during the treatment process must be recorded in detail. The record of adverse events should include a description of the adverse event and all related symptoms, the time of occurrence, severity, duration, measures taken, and the final outcome and outcome, as well as an evaluation of the possible correlation between the adverse event and treatment.
up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liaocheng People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • stress injury

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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