Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs) | Experimental | 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 | Other | Standard therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pressure Ulcer Scale for Healing (PUSH) | 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 | Serum epidermal growth factor (EGF) and vascular endothelial growth factor (VEGF) were detected during treatment. | Baseline,1, 2 and 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing time | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunling Yang, bachelor | Contact | 13346256117 | 0635-8276115 | yangchunling01@126.com |
| 1966-03-07 | Contact |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central laboratory | Recruiting | Liaocheng | Shandong | 252000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37924749 | Result | Daneste H, Mohammadzadeh Boukani L, Ramezani N, Asadi F, Zaidan HK, Sadeghzade A, Ehsannia M, Azarashk A, Gholizadeh N. Combination therapy along with mesenchymal stem cells in wound healing; the state of the art. Adv Med Sci. 2023 Sep;68(2):441-449. doi: 10.1016/j.advms.2023.10.006. Epub 2023 Nov 2. | |
| 33607926 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Control group | Other | Standard therapy for patients with stage 3 and 4 stress injury |
|
| Positive rate of bacterial culture |
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 |
| Qu S, Hu Z, Zhang Y, Wang P, Li S, Huang S, Dong Y, Xu H, Rong Y, Zhu W, Tang B, Zhu J. Clinical Studies on Platelet-Rich Plasma Therapy for Chronic Cutaneous Ulcers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Adv Wound Care (New Rochelle). 2022 Feb;11(2):56-69. doi: 10.1089/wound.2020.1186. Epub 2021 Jun 8. |
| 37711926 | Result | Kunder V, Sharma KC, Rizvi Z, Soubelet R, Ducharme M. The Use of Platelet-Rich Plasma in the Treatment of Diabetic Foot Ulcers: A Scoping Review. Cureus. 2023 Aug 14;15(8):e43452. doi: 10.7759/cureus.43452. eCollection 2023 Aug. |
| 31600109 | Result | Rainys D, Cepas A, Dambrauskaite K, Nedzelskiene I, Rimdeika R. Effectiveness of autologous platelet-rich plasma gel in the treatment of hard-to-heal leg ulcers: a randomised control trial. J Wound Care. 2019 Oct 2;28(10):658-667. doi: 10.12968/jowc.2019.28.10.658. |
| 35547633 | Result | Wang Y, Luan S, Yuan Z, Wang S, Fan S, Ma C, Wu S. The Combined Use of Platelet-Rich Plasma Clot Releasate and Allogeneic Human Umbilical Cord Mesenchymal Stem Cells Rescue Glucocorticoid-Induced Osteonecrosis of the Femoral Head. Stem Cells Int. 2022 May 2;2022:7432665. doi: 10.1155/2022/7432665. eCollection 2022. |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
Not provided
Not provided