Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01082822
• Other study ID #: TEFMMU
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: March 8, 2010
• Last updated: March 8, 2010
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: October 2009
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 50 Years

Eligibility

Inclusion Criteria:

1. adult chronic periodontitis

2. pathological lesion is stable after the routine mechanical and chemical treatment.

3. the local pathological lesion has the subbony defect

4. the oral heath was kept approved.

5. there are more 2 teeth with the continued lesion

Exclusion Criteria:

1. the age>50 year or < 40year

2. the patient has the genetic background of the periodontitis.

3. the bone destruction was larger than 2/3 of the root length.

4. the preclinical treatment was stable.

5. the severe systematic diseases.

6. the patients who can not cooperate with the whole the observation.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Biological:
• cell sheet pellets and cell sheet fragment
the denuded root surface area was calculated to determine the size of the transplanted cell sheet in the of proportion of the 2cm X 2cm cell sheet to the 1cm X 1cm denuded area

Locations

Country	Name	City	State
China	Research and Develop Center for Tissue Engineering, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Yang Z, Jin F, Zhang X, Ma D, Han C, Huo N, Wang Y, Zhang Y, Lin Z, Jin Y. Tissue engineering of cementum/periodontal-ligament complex using a novel three-dimensional pellet cultivation system for human periodontal ligament stem cells. Tissue Eng Part C Methods. 2009 Dec;15(4):571-81. doi: 10.1089/ten.tec.2008.0561. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Plaque Index was mean score of each surface. Probing depth and Attachment loss are distance from the base of the sulcus and the cemento-enamel junction to the free gingival margin. bone loss		Sept. 2009	Yes