Clinical trial · Interventional
The Role of Mesenchymal Stem Cell and Exosome in Treating 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Disease | — | UNRESOLVED | — |
| Pilonidal Sinus | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Crystallized phenol | Other | — | UNRESOLVED |
| Crystallized phenol + Exosome | Biological | — | UNRESOLVED |
| Crystallized phenol + Exosome + Stem Cell | Biological | — | UNRESOLVED |
| Crystallized phenol + Stem Cell | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Crystallized phenol
- description
- 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.
- interventionNames
- Other: Crystallized phenol
- type
- EXPERIMENTAL
- label
- Crystallized phenol + Exosome
- description
- 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.
- interventionNames
- Biological: Crystallized phenol + Exosome
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available