Periodontal Tissue Regeneration Using Autologous Periodontal Ligament Stem Cells

NCT01357785 | Unknown Phase 1 DMC

• 1 other identifier: 007
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Pocket

Keywords

Periodontal ligament stem cells; Periodontal regeneration; Clinical trial; Deep intraosseous defects

Outcome Measures

Primary Outcomes (1)

• Periodontal bone regeneration

  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).

  1 year

Secondary Outcomes (1)

• Clinical parameters

  3 months -12 months

Interventions

Cell therapy PROCEDURE

The use of periodontal ligament stem cells for periodontal regeneration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Those who have accomplished initial preparation and have been showing good compliance
• 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
• 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
• 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
• 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.
• Those who understand the purposes of the trial and are capable of making an independent decision to comply with trial requirements
• Those who are able to visit our hospital in accordance with the trial schedule

You may not qualify if:

• Those administered a calcium antagonist during the 4 weeks preceding the surgery
• Those in need of administration of adrenal cortical steroid (equivalent to\>20 mg/day of Predonin) within 4 weeks after the surgery
• Those scheduled to undergo a surgical operation in the vicinity of the tooth to investigate within 36 weeks after surgery
• Those with coexisting mental or consciousness disorder
• Those with coexisting malignant tumour or history of the same
• Those with coexisting diabetes (HbA1C \>6.5%)
• Those in an extremely poor nutritional condition (serum albumin concentration \<2 g/dL)
• Those with 200 mL of blood drawn during the 4 weeks preceding the surgery
• Those administered another investigational drug during the 24 h preceding investigational drug administration
• Those with coexisting disorder of the kidney, liver, blood and/or circulatory system (Grade 2 or above)
• Those who are either pregnant, possibly pregnant or breast-feeding, or who hope to become pregnant during the period of the trial
• Those with a previous history of hypersensitivity to any biological active drugs
• Those who smoke more than 10 pieces of cigarettes
• Those who are involved in the research team of this trial
• Others who the investigators or sub-investigators determined as unsuitable for the trial

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

School of Stomatology, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (15)

• Chen FM, Jin Y. Periodontal tissue engineering and regeneration: current approaches and expanding opportunities. Tissue Eng Part B Rev. 2010 Apr;16(2):219-55. doi: 10.1089/ten.TEB.2009.0562.

  PMID: 19860551 BACKGROUND

• Sonoyama W, Liu Y, Fang D, Yamaza T, Seo BM, Zhang C, Liu H, Gronthos S, Wang CY, Wang S, Shi S. Mesenchymal stem cell-mediated functional tooth regeneration in swine. PLoS One. 2006 Dec 20;1(1):e79. doi: 10.1371/journal.pone.0000079.

  PMID: 17183711 BACKGROUND

• Seo BM, Miura M, Gronthos S, Bartold PM, Batouli S, Brahim J, Young M, Robey PG, Wang CY, Shi S. Investigation of multipotent postnatal stem cells from human periodontal ligament. Lancet. 2004 Jul 10-16;364(9429):149-55. doi: 10.1016/S0140-6736(04)16627-0.

  PMID: 15246727 BACKGROUND

• Feng F, Akiyama K, Liu Y, Yamaza T, Wang TM, Chen JH, Wang BB, Huang GT, Wang S, Shi S. Utility of PDL progenitors for in vivo tissue regeneration: a report of 3 cases. Oral Dis. 2010 Jan;16(1):20-8. doi: 10.1111/j.1601-0825.2009.01593.x.

  PMID: 20355278 BACKGROUND

• Liu Y, Zheng Y, Ding G, Fang D, Zhang C, Bartold PM, Gronthos S, Shi S, Wang S. Periodontal ligament stem cell-mediated treatment for periodontitis in miniature swine. Stem Cells. 2008 Apr;26(4):1065-73. doi: 10.1634/stemcells.2007-0734. Epub 2008 Jan 31.

  PMID: 18238856 BACKGROUND

• Fang D, Seo BM, Liu Y, Sonoyama W, Yamaza T, Zhang C, Wang S, Shi S. Transplantation of mesenchymal stem cells is an optimal approach for plastic surgery. Stem Cells. 2007 Apr;25(4):1021-8. doi: 10.1634/stemcells.2006-0576. Epub 2006 Dec 14.

  PMID: 17170063 BACKGROUND

• Park JC, Kim JM, Jung IH, Kim JC, Choi SH, Cho KS, Kim CS. Isolation and characterization of human periodontal ligament (PDL) stem cells (PDLSCs) from the inflamed PDL tissue: in vitro and in vivo evaluations. J Clin Periodontol. 2011 Aug;38(8):721-31. doi: 10.1111/j.1600-051X.2011.01716.x. Epub 2011 Mar 30.

  PMID: 21449989 BACKGROUND

• Krasner P, Verlander P. Stem cells in dentistry and medicine: the dentist's role. Dent Today. 2011 Jan;30(1):128, 130-4; quiz 135.

  PMID: 21306072 BACKGROUND

• Simsek SB, Keles GC, Baris S, Cetinkaya BO. Comparison of mesenchymal stem cells and autogenous cortical bone graft in the treatment of class II furcation defects in dogs. Clin Oral Investig. 2012 Feb;16(1):251-8. doi: 10.1007/s00784-010-0486-7. Epub 2010 Nov 18.

  PMID: 21086003 BACKGROUND

• Yang Y, Rossi FM, Putnins EE. Periodontal regeneration using engineered bone marrow mesenchymal stromal cells. Biomaterials. 2010 Nov;31(33):8574-82. doi: 10.1016/j.biomaterials.2010.06.026. Epub 2010 Sep 15.

  PMID: 20832109 BACKGROUND

• Washio K, Iwata T, Mizutani M, Ando T, Yamato M, Okano T, Ishikawa I. Assessment of cell sheets derived from human periodontal ligament cells: a pre-clinical study. Cell Tissue Res. 2010 Sep;341(3):397-404. doi: 10.1007/s00441-010-1009-1. Epub 2010 Jul 15.

  PMID: 20632035 BACKGROUND

• Iwata T, Yamato M, Zhang Z, Mukobata S, Washio K, Ando T, Feijen J, Okano T, Ishikawa I. Validation of human periodontal ligament-derived cells as a reliable source for cytotherapeutic use. J Clin Periodontol. 2010 Dec;37(12):1088-99. doi: 10.1111/j.1600-051X.2010.01597.x.

  PMID: 20618549 BACKGROUND

• Yang ZH, Jin F, Zhang XJ, Liu X, Zhang YF, Liu JQ, Duan YZ, Jin Y. A novel possible strategy based on self-assembly approach to achieve complete periodontal regeneration. Artif Organs. 2010 Jul;34(7):603-9. doi: 10.1111/j.1525-1594.2009.00991.x. Epub 2010 Jun 10.

  PMID: 20545657 BACKGROUND

• Wei N, Gong P, Liao D, Yang X, Li X, Liu Y, Yuan Q, Tan Z. Auto-transplanted mesenchymal stromal cell fate in periodontal tissue of beagle dogs. Cytotherapy. 2010 Jul;12(4):514-21. doi: 10.3109/14653241003709702.

  PMID: 20370352 BACKGROUND

• Chen FM, Gao LN, Tian BM, Zhang XY, Zhang YJ, Dong GY, Lu H, Chu Q, Xu J, Yu Y, Wu RX, Yin Y, Shi S, Jin Y. Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial. Stem Cell Res Ther. 2016 Feb 19;7:33. doi: 10.1186/s13287-016-0288-1.

  PMID: 26895633 DERIVED

MeSH Terms

Conditions

Periodontal Pocket

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Songtao Shi, Ph.D.

  School of Stomatology, Fourth Military Medical Univeristy; Ostrow School of Dentistry, University of Southern California

  STUDY DIRECTOR

Central Study Contacts

Fa-Ming Chen, Ph.D.

CONTACT

86 29 8477 6096; cfmsunhh@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fourth Military Medical University

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 23, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2014
• Last Updated: September 13, 2011

Record last verified: 2011-09

Locations

CN (1)