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

NCT ID: NCT06391307

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-11
• Study Completion Date: 2024-12-30

Brief 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).

Detailed Description

Pilonidal sinus disease (PSD) is an infectious or inflammatory condition beneath the skin at the peak of the gluteal cleft in the sacrococcygeal area. It is a chronic condition characterized by discharge, infection, and pain. Although it can occur during adolescence, it is most commonly seen in adult males, leading to a focus on adult treatments in research. Surgical treatment was first implemented by Anderson in 1847. Since then, various surgical and medical treatment options have been explored, yet there is no widely accepted standardized treatment. The ideal treatment should be simple, require a short hospital stay, have low recurrence rates, provide good cosmetic results, be cost-effective, cause minimal pain, and allow a quick return to social life, making the surgical approach contentious.

Maurice and Greenwood first reported the application of liquid phenol in 1964, initially under general anesthesia, later shifting to local anesthesia. Due to high recurrence rates with liquid phenol, Dogru and colleagues introduced the crystallized phenol (CP) procedure, a minimally invasive method now commonly used in adults.

Recent years have shown that stem cells and exosomes promote tissue healing and reduce inflammation. Known for their ability to differentiate into various cell types, stem cells, and exosomes play critical roles in intercellular communication, containing a variety of molecules. Their use in surgical fields has become popular as they speed up the post-operative healing process and reduce the risk of complications. Research in the literature supports that stem cells and exosomes accelerate wound healing (e.g., Nourian Dehkordi A, et al. 2019).

This study is based on two main premises: firstly, to identify the potential healing effects of stem cell and exosome applications in treating pilonidal sinus disease; and secondly, to comparatively assess the impact of these applications on surgical outcomes, specifically regarding surgery duration, complications, and the healing process. Comparing these two groups will help determine the value of stem cell and exosome applications in managing pilonidal sinus disease.

Conditions

Pilonidal Sinus; Pilonidal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Crystallized phenol

In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol into the wound.

Group Type: ACTIVE_COMPARATOR

Crystallized phenol

Intervention Type: OTHER

Crystallized phenol + Exosome + Stem Cell

Crystallized phenol + Exosome

In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Exosome into the wound.

Group Type: EXPERIMENTAL

Crystallized phenol + Exosome

Intervention Type: BIOLOGICAL

Crystallized phenol + Exosome will be applied to wound area.

Crystallized phenol + Stem Cell

In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Stem cell into the wound.

Group Type: EXPERIMENTAL

Crystallized phenol + Stem Cell

Intervention Type: BIOLOGICAL

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

Crystallized phenol + Exosome + Stem Cell

In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Stem cell + Exosome into the wound.

Group Type: EXPERIMENTAL

Crystallized phenol + Exosome + Stem Cell

Intervention Type: BIOLOGICAL

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

Interventions

Crystallized phenol

Crystallized phenol + Exosome + Stem Cell

Intervention Type: OTHER

Crystallized phenol + Exosome

Crystallized phenol + Exosome will be applied to wound area.

Intervention Type: BIOLOGICAL

Crystallized phenol + Stem Cell

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

Intervention Type: BIOLOGICAL

Crystallized phenol + Exosome + Stem Cell

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Crystallized phenol will be applied to wound area.

Eligibility 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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Necmi Kadıoğlu Hospital

OTHER

Sponsor Role: collaborator

Mustafa Azizoğlu

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Azizoğlu

Head of Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mustafa Azizoğlu, MD

Role: PRINCIPAL_INVESTIGATOR

Esenyurt State Hospital

Locations

Mustafa Azizoğlu

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Mustafa Azizoğlu, MD, PhD

Role: CONTACT

mdmazizoglu@gmail.com

+905447448244

Facility Contacts

Mustafa Azizoğlu

Role: primary

mdmazizoglu@gmail.com

+905447448244

Other Identifiers

Stem Cell PNS

Identifier Type: -

Identifier Source: org_study_id