Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis
Summary
Cell sheet technique possess the properties of conserving the ECM, rich molecules and retaining cell vitality, and will promote the capacity of cell adhesion and proliferation. The stem cell based cell sheet therapy has been utilized in many fields and scored the satisfactory results. Periodontitis is a chronic disease which causes the destruction of the periodontal tissue and leads to the teeth loss in the end. The routine cell-based therapy to the periodontitis was confronted with many difficulties. In the investigators previous preclinical research, +the investigators fabricated periodontal ligament stem cell (PDLSC) pellets and cell sheet fragment and applied them in the periodontal defect area for tissue regeneration and periodontitis treatment. And the investigators carried out a comprehensive study of the PDLSC allograft. The host responses and implanted cell fates were recorded. After the scientific investigation of the preclinical study, the investigators designed the preliminary clinical trial of PDLSC cell sheet for the chronic periodontitis therapy in the aims to test the PDLSC fates and explore one ideal transplantation mode.
Description
our protocol mainly includes following steps:
1. select periodontitis patients :all patients were given the comprehensive examination on the oral condition including clinical examination, radiological evaluation and the immune system tests
2. select healthy donor teeth for PDLSC isolation and expansion.
3. fabricate the cell sheet and prepare the PDLSC cell sheet pellets and cell sheet fragment.
4. patients given the routine mechanical and chemical treatment for 4 weeks were randomized divided into 4 groups according to the visit time: i) the cell sheet fragment plus bio-ss transplantation; ii) the cell sheet pellets plus bioss transplantation; iii) the bio-ss transplantation and iv) the control.
5. all the operations were carried out as the routine GBR procedures.
6. the clinical, radiological examination and the changes of the immune system at the point of 1 day before and 4weeks, 12weeks, 24weeks and one year after the intervention were recorded and compared.
Study Design
Allocation: Non-Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Chronic Periodontitis
Intervention
cell sheet pellets and cell sheet fragment
Location
Research and Develop Center for Tissue Engineering, Fourth Military Medical University
Xi'an
Shaanxi
China
710032
Status
Active, not recruiting
Source
Fourth Military Medical University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01082822
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tight Junctions
Cell-cell junctions that seal adjacent epithelial cells together, preventing the passage of most dissolved molecules from one side of the epithelial sheet to the other. (Alberts et al., Molecular Biology of the Cell, 2nd ed, p22)
Chronic Periodontitis
Chronic inflammation and loss of PERIODONTIUM that is associated with the amount of DENTAL PLAQUE or DENTAL CALCULUS present. Chronic periodontitis occurs mostly in adults and was called adult periodontitis, but this disease can appear in young people.
Periodontitis
Inflammation and loss of connective tissues supporting or surrounding the teeth. This may involve any part of the PERIODONTIUM. Periodontitis is currently classified by disease progression (CHRONIC PERIODONTITIS; AGGRESSIVE PERIODONTITIS) instead of age of onset. (From 1999 International Workshop for a Classification of Periodontal Diseases and Conditions, American Academy of Periodontology)
Posters As Topic
Single or multi-sheet notices made to attract attention to events, activities, causes, goods, or services. They are for display, usually in a public place and are chiefly pictorial.
Antifreeze Proteins, Type Iii
A subclass of ANTIFREEZE PROTEINS that are globular, 6.5 kDa in size and contain compact beta-sheet structures.
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