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RECRUITING
NCT06391307
NA

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

Sponsor: Mustafa Azizoğlu

View on ClinicalTrials.gov

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).

Official title: The Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children: A Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

1 Day - 18 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-05-11

Completion Date

2024-12-30

Last Updated

2024-05-14

Healthy Volunteers

No

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.

Locations (1)

Mustafa Azizoğlu

Istanbul, Turkey (Türkiye)