Periodontal Tissue Regeneration Using Autologous Periodontal Ligament Stem Cells (PDLSC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by Fourth Military Medical University
Sponsor:
Information provided by (Responsible Party):
Fa-Ming Chen, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01357785
First received: May 18, 2011
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

The purpose of this clinical trial is to both clarify the efficiency of autologous periodontal ligament (PDL) stem cells to regenerate periodontal tissue in periodontitis patients with deep intraosseous defects (>5 mm) and to confirm the safety of using autologous stem cells in clinical periodontal regenerative medicine. This is a single-centre, randomized, placebo-controlled study. This study has been approved by the ethical committees of School of Stomatology, Fourth Military Medical University. The study will be conducted according to the Declaration of Helsinki.


Condition Intervention Phase
Periodontal Pocket
Procedure: Cell therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Periodontal Tissue Regeneration Using Autologous Periodontal Ligament Stem Cells: Randomized Controlled Clinical Trial

Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • Periodontal bone regeneration [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The main outcome measures in the study protocol were: rate of increase in alveolar bone height and millimeter of clinical attachement level (CAL) regained. In addition, we examined whether and to what extent adverse events, for which causal relationships with the use of PDL cell were not ruled out, emerged. We set rate of increase in alveolar bone height as the most statistically important outcome (primary outcome).


Secondary Outcome Measures:
  • Clinical parameters [ Time Frame: 3 months -12 months ] [ Designated as safety issue: No ]
    pocket depth (PD), attachment level (AL), and tooth mobility (TM)


Estimated Enrollment: 35
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Cell therapy
    The use of periodontal ligament stem cells for periodontal regeneration
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Those diagnosed as having, from radiography and other results, 2- or 3-walled vertical intrabony defect 3 mm deep from the top of the remaining alveolar bone
  2. Those who have accomplished initial preparation and have been showing good compliance
  3. Those with mobility of the tooth to investigate of Degree 2 or less and with width of attached gingiva for which the existing Guided Tissue Regeneration (GTR) and bone graft implantation treatment are considered appropriate
  4. Those for whom supportive periodontal treatment is applicable (the tooth has the potential to be maintain for at least 3 years), in accordance with usual post-operative procedures following flap operation and GTR treatment
  5. Those whose oral hygiene is well established and who are able to perform appropriate tooth brushing and cleaning following instructions of the investigators and/or sub-investigators after investigational drug administration
  6. Those 18-years-old and <65-years-old Those who has at least one tooth (e.g. wisdom tooth) that is need to be extracted and the patient agrees the tooth extraction.
  7. Those who understand the purposes of the trial and are capable of making an independent decision to comply with trial requirements
  8. Those who are able to visit our hospital in accordance with the trial schedule

Exclusion Criteria:

  1. Those administered a calcium antagonist during the 4 weeks preceding the surgery
  2. Those in need of administration of adrenal cortical steroid (equivalent to>20 mg/day of Predonin) within 4 weeks after the surgery
  3. Those scheduled to undergo a surgical operation in the vicinity of the tooth to investigate within 36 weeks after surgery
  4. Those with coexisting mental or consciousness disorder
  5. Those with coexisting malignant tumour or history of the same
  6. Those with coexisting diabetes (HbA1C >6.5%)
  7. Those in an extremely poor nutritional condition (serum albumin concentration <2 g/dL)
  8. Those with 200 mL of blood drawn during the 4 weeks preceding the surgery
  9. Those administered another investigational drug during the 24 h preceding investigational drug administration
  10. Those with coexisting disorder of the kidney, liver, blood and/or circulatory system (Grade 2 or above)
  11. Those who are either pregnant, possibly pregnant or breast-feeding, or who hope to become pregnant during the period of the trial
  12. Those with a previous history of hypersensitivity to any biological active drugs
  13. Those who smoke more than 10 pieces of cigarettes
  14. Those who are involved in the research team of this trial
  15. Others who the investigators or sub-investigators determined as unsuitable for the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357785

Contacts
Contact: Fa-Ming Chen, Ph.D. 86 29 8477 6096 cfmsunhh@fmmu.edu.cn

Locations
China, Shaanxi
School of Stomatology, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yan Jin, Ph.D.    86 29 8477 6141    yanjin@fmmu.edu.cn   
Contact: Fa-Ming Chen, Ph.D.    86 29 8477 6096    cfmsunhh@fmmu.edu.cn   
Principal Investigator: Yan Jin, Ph.D.         
Principal Investigator: Fa-Ming Chen, Ph.D.         
Sub-Investigator: Yong-Jie Zhang, Ph.D.         
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Study Director: Songtao Shi, Ph.D. School of Stomatology, Fourth Military Medical Univeristy; Ostrow School of Dentistry, University of Southern California
  More Information

Publications:

Responsible Party: Fa-Ming Chen, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01357785     History of Changes
Other Study ID Numbers: 007
Study First Received: May 18, 2011
Last Updated: September 12, 2011
Health Authority: China: Ministry of Health

Keywords provided by Fourth Military Medical University:
Periodontal ligament stem cells
Periodontal regeneration
Clinical trial
Deep intraosseous defects

Additional relevant MeSH terms:
Periodontal Pocket
Mouth Diseases
Periodontal Diseases
Periodontitis
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 21, 2014