Actively Recruiting

Phase Not Applicable
Age: 1Day - 18Years
All Genders
NCT06391307

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

Led by Mustafa Azizoğlu · Updated on 2024-05-14

120

Participants Needed

1

Research Sites

33 weeks

Total Duration

On this page

Sponsors

M

Mustafa Azizoğlu

Lead Sponsor

N

Necmi Kadıoğlu Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 1Day - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 0 to 18 years
  • Patients with chronic non-healing wounds and pilonidal sinus disease
Not Eligible

You will not qualify if you...

  • Patients with epilepsy
  • Patients with diabetes
  • Patients with hypertension
  • Patients with other chronic diseases

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Mustafa Azizoğlu

Istanbul, Turkey (Türkiye), 34430

Actively Recruiting

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Research Team

M

Mustafa Azizoğlu, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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