The Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children
1 other identifier
interventional
120
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2024
CompletedFirst Posted
Study publicly available on registry
April 30, 2024
CompletedStudy Start
First participant enrolled
May 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedMay 14, 2024
May 1, 2024
7 months
April 22, 2024
May 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Wound healing time
In the control group, the healing process generally takes about 2-3 weeks. In the experimental group, a shorter duration is expected. In this study, the wound healing times of both groups will be evaluated and compared.
3 weeks
Cosmetic results
In this study, the worst healing wounds will receive a score of 1, and the best-healed wounds, which are closest to normal skin, will receive a score of 10. In short, a low score indicates poor wound healing and poor cosmetic, while a high score indicates that the wound has achieved a good cosmetic appearance.
2 month
Skin burn rate
In patients treated with crystallized phenol, skin burns can occur during application. To prevent this, Furacin ointment is applied around the wound. However, we still encounter skin burns. In this study, it is expected that the experimental groups will have a lower burn rate compared to the control group. The burn rate will be evaluated in this study.
2 weeks
Average time to full daily activities
It refers to the time when patients return to their routine lives after the procedure.
1 week
VAS score
Patient visual analog scale (VAS) scores will be assessed both prior to the procedure and again 10 days, 20 days following the procedure and after recovery.
7 weeks
Success rate
The succes rate will be calculated after interventions
7 weeks
Recurrence rate
The recurrence rate will be calculated after interventions
7 weeks
Secondary Outcomes (3)
Bleeding rate
1 week
Infection rate
7 week
Total complication rate
7 weeks
Study Arms (4)
Crystallized phenol
ACTIVE COMPARATORIn 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.
Crystallized phenol + Exosome
EXPERIMENTALIn 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.
Crystallized phenol + Stem Cell
EXPERIMENTALIn 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.
Crystallized phenol + Exosome + Stem Cell
EXPERIMENTALIn 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.
Interventions
Crystallized phenol + Exosome + Stem Cell
Crystallized phenol + Exosome will be applied to wound area.
Crystallized phenol + Stem cell will be applied to wound area.
Crystallized phenol + Exosome + Stem Cell will be applied to wound area.
Eligibility Criteria
You may qualify if:
- years children.
- Patients with chronic non-healing wound and pilonidal sinus diseases.
You may not qualify if:
- Patients with epilepsia
- Patients with diabetes
- Patients with hypertension
- Patients with chronic other diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mustafa Azizoğlulead
- Necmi Kadıoğlu Hospitalcollaborator
Study Sites (1)
Mustafa Azizoğlu
Istanbul, 34430, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mustafa Azizoğlu, MD
Esenyurt State Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of Department
Study Record Dates
First Submitted
April 22, 2024
First Posted
April 30, 2024
Study Start
May 11, 2024
Primary Completion
November 30, 2024
Study Completion
December 30, 2024
Last Updated
May 14, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share