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 range

18 Years – 80 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Pressure Ulcer Scale for Healing (PUSH)

Timeframe: Baseline,1,2,4 and 6 weeks

Change from baseline in Determination of growth factor content

Timeframe: Baseline,1, 2 and 3 weeks

Trial details

NCT IDNCT06302582

SponsorLiaocheng People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-25

Contact for this trial

Chunling Yang, bachelor

13346256117 yangchunling01@126.com

View on ClinicalTrials.gov More Pressure Injuries - Stage 3 trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.