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AzTrials

Pressure Injuries - Stage 3Phase 1/2NCT06302582

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

A Phase 1/2 study testing Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs) in people with Pressure Injuries - Stage 3 and Pressure Injuries - Stage 4, run by Liaocheng People's Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
29 Feb 2024to 25 Nov 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Chunling Yang, bachelor contact

13346256117 ext. 0635-8276115

yangchunling01@126.com

1966-03-07 contact

China1 site, 1 recruiting

  • Central laboratory

    Liaocheng, Shandong, 252000

    changhui Zhou, postgraduate, 13562078772, zhouchanghui008@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs), Control group
Keywords
Mesenchymal stem cells, Platelet rich plasma, Pressure Injuries
Medical subject headings
Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • Control groupOther

    Standard therapy for patients with stage 3 and 4 stress injury

Study groups in NCT06302582
Study groupRoleWhat they receive
Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs)ExperimentalInject 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.
Receives: Biological: Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs)
Control groupOtherStandard therapy
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Change from baseline in Determination of growth factor content

    Serum epidermal growth factor (EGF) and vascular endothelial growth factor (VEGF) were detected during treatment.

    Measured: Baseline,1, 2 and 3 weeks

Secondary outcomes (2)

  1. 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.

    Measured: up to 4 months

  2. 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.

    Measured: Baseline and 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start29 Feb 2024 (estimated)
  3. Primary completion25 Nov 2024 (estimated)
  4. Study completion25 Nov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06302582
Sponsor's protocol ID
stress injury
Status last verified
Feb 2024
First submitted
7 Feb 2024
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37924749

  • 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.

    PubMed 33607926

  • 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.

    PubMed 37711926

  • 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.

    PubMed 31600109

  • 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.

    PubMed 35547633

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs) in people with Pressure Injuries - Stage 3 and Pressure Injuries - Stage 4, run by Liaocheng People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chunling Yang, bachelor (13346256117 ext. 0635-8276115, yangchunling01@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Pressure Ulcer Scale for Healing (PUSH) (time frame: Baseline,1,2,4 and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06302582, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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