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The Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children

NCT06391307 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-05-14

No results posted yet for this study

Summary

Chronic wounds that fail to heal over extended periods pose a significant financial burden on the healthcare system, underscoring the urgent need to enhance clinical treatments. Among the most promising approaches are stem cell-based therapies. Substantial evidence suggests that mesenchymal stem cells (MSCs) can facilitate the healing of chronic wounds in both animal models and preclinical studies, primarily through their paracrine actions. The bioactive factors and cytokines secreted by MSCs can be harvested in the form of conditioned medium. This medium has been processed into a lyophilized powder for clinical use. Patients with chronic wounds will recruited and divided into two groups: the control group will receive the commonly used fibroblast growth factor, while the experimental group was treated with the lyophilized powder. The study aims to assess the efficacy and safety of this Stem cell and exosome in treating chronic wounds (especially pilonidal sinus).

Conditions

  • Pilonidal Sinus
  • Pilonidal Disease

Interventions

OTHER

Crystallized phenol

Crystallized phenol + Exosome + Stem Cell

BIOLOGICAL

Crystallized phenol + Exosome

Crystallized phenol + Exosome will be applied to wound area.

BIOLOGICAL

Crystallized phenol + Stem Cell

Crystallized phenol + Stem cell will be applied to wound area.

BIOLOGICAL

Crystallized phenol + Exosome + Stem Cell

Crystallized phenol + Exosome + Stem Cell will be applied to wound area.

Sponsors & Collaborators

  • Necmi Kadıoğlu Hospital

    collaborator OTHER

  • Mustafa Azizoğlu

    lead OTHER

Principal Investigators

  • Mustafa Azizoğlu, MD · Esenyurt State Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-11
Primary Completion
2024-11-30
Completion
2024-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06391307 on ClinicalTrials.gov