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

NCT06302582 | Recruiting Phase 1

• 1 other identifier: stress injury
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Injuries - Stage 3; Pressure Injuries - Stage 4

Keywords

Mesenchymal stem cells; Platelet rich plasma; Pressure Injuries

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Wound healing time

  up to 4 months

• Positive rate of bacterial culture

  Baseline and 2 weeks

Other Outcomes (1)

• Safety evaluation

  up to 1 week

Study Arms (2)

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.

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

Control group

OTHER

Standard therapy

Other: Control group

Interventions

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

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

Control group OTHER

Standard therapy for patients with stage 3 and 4 stress injury

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaocheng People's Hospital: lead

Study Sites (1)

Central laboratory

Liaocheng, Shandong, 252000, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 37924749 RESULT

• 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.

  PMID: 33607926 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.

  PMID: 37711926 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.

  PMID: 31600109 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.

  PMID: 35547633 RESULT

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Chunling Yang, bachelor

CONTACT

13346256117; yangchunling01@126.com

1966-03-07

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: March 12, 2024
• Study Start: February 29, 2024
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)