Using stem cells and platelet-rich plasma to treat severe pressure injuries
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 testing if using stem cells from umbilical cords along with platelet-rich plasma can help heal severe pressure injuries in patients.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Liaocheng People's Hospital Academic / other |
| Locations | 1 site (Liaocheng, Shandong) |
| Trial ID | NCT06302582 on ClinicalTrials.gov |
What this trial studies
This open-label, single-center trial evaluates the efficacy and safety of combining human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) with platelet-rich plasma (PRP) for treating stage 3 and 4 pressure injuries. The study addresses the increasing incidence of pressure injuries, which significantly impact patients' quality of life and healthcare costs. By leveraging the immunomodulatory and anti-inflammatory properties of hUC-MSCs alongside the wound healing benefits of PRP, the researchers aim to find a more effective treatment method. The trial will assess both the effectiveness and safety of this combined approach in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with stage 3 or 4 pressure injuries who have no complications affecting wound healing.
Not a fit: Patients with coagulation disorders, diabetes, skin diseases, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing outcomes for patients with severe pressure injuries.
How similar studies have performed: While there are few reports on the combination of PRP and hUC-MSCs for pressure injury treatment, similar approaches in other contexts have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Liaocheng, Shandong
- Central laboratory — Liaocheng, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Chunling Yang, bachelor
- Email: yangchunling01@126.com
- Phone: 13346256117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.