Using stem cells and exosomes to treat pilonidal sinus disease in children
The Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children: A Prospective Randomized Controlled Trial
NA · Necmi Kadıoğlu Hospital · NCT06391307
This study is testing if using stem cells and exosomes can help heal chronic wounds from pilonidal sinus disease in children better than standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | Necmi Kadıoğlu Hospital (other) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06391307 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of mesenchymal stem cells and exosomes in treating chronic wounds associated with pilonidal sinus disease in children. Participants will be divided into groups receiving different treatments, including a control group receiving fibroblast growth factor and an experimental group receiving a lyophilized powder derived from stem cells. The study aims to evaluate the safety and efficacy of these innovative therapies in promoting wound healing and reducing inflammation. By leveraging the regenerative properties of stem cells and exosomes, the trial seeks to provide a new approach to managing this challenging condition.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-18 years with chronic non-healing wounds and pilonidal sinus disease.
Not a fit: Patients with conditions such as epilepsy, diabetes, hypertension, or other chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing outcomes for children suffering from chronic pilonidal sinus disease.
How similar studies have performed: While the use of stem cells and exosomes in wound healing is gaining traction, this specific application in pilonidal sinus disease is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 0-18 years children. * Patients with chronic non-healing wound and pilonidal sinus diseases. Exclusion Criteria: * Patients with epilepsia * Patients with diabetes * Patients with hypertension * Patients with chronic other diseases.
Where this trial is running
Istanbul
- Mustafa Azizoğlu — Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Mustafa Azizoğlu, MD — Esenyurt State Hospital
- Study coordinator: Mustafa Azizoğlu, MD, PhD
- Email: mdmazizoglu@gmail.com
- Phone: +905447448244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pilonidal Sinus, Pilonidal Disease, pilonidal sinus disease, Children, wound healing, stem cell, exosome