An exploratory open trial to examine the safety of transplantation of autologous adipose tissue-derived stem cells for periodontal regeneration.

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000007698
• Date of registration: 09/04/2012
• Prospective Registration: Yes
• Primary sponsor: Osaka University
• Public title: An exploratory open trial to examine the safety of transplantation of autologous adipose tissue-derived stem cells for periodontal regeneration.
• Scientific title: An exploratory open trial to examine the safety of transplantation of autologous adipose tissue-derived stem cells for periodontal regeneration. - An exploratory open trial of transplantation of adipose tissue-derived stem cells for periodontal regeneration.
• Date of first enrolment: 2012/11/01
• Target sample size: 12
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008984
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Masahiro KITAMURA
• Affiliation: Osaka University Graduate School of Dentistry Department of Periodontology, Division of Oral Biology and Disease Control

• Name: Shinya MURAKAMI
• Affiliation: Osaka University Graduate School of Dentistry Department of Periodontology, Division of Oral Biology and Disease Control

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: (1) Persons whose clinical attachment level of experimental teeth cannot be measured. (2) Persons who have or have had malignant tumor. (3) Persons who are suspected to have malignant tumor or precancerous lesions at the oral cavity inspection before the registration. (4) Persons who have administered bisphosphonates, or are to administer the drug after the registration. (5) Persons who need to undergo the treatments, such as surgical treatment, restorative treatment or root canal treatment, which affect the experimental sites within 36 weeks after the transplantation of adipose tissue-derived stem cells. (6) Persons who are either pregnant, breast-feeding or possibly pregnant by the pregnancy test before the registration, or who hope to become pregnant within 36 weeks after the transplantation of adipose tissue-derived stem cells. (7) Persons who suffer from disorders of kidney, liver or blood. (8) Persons whose hemoglobinA1c is more than 6.5% in the blood test before the entry (9) Persons who suffer from active infectious diseases. (10) Persons who have the history of dependence on alcohol or drugs within 6 months before the registrarion. (11) Persons who suffer from mental or consciousness disorders. (12) Persons who have the positive reaction to the tests for hepatitis C virus antibody, hepatitis B virus antigen, human T-lymphotropic virus-1 antibody or human immunodeficiency virus antibody. (13) Persons who are judged not eligible for the subjects of this study by the principal investigator.

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

periodontitis

Intervention(s)

Aspiration of abdominal adipose tissue Transplantation of adipose tissue-derived stem cells to the experimental site during periodontal surgery

Primary Outcome(s)

The occurrence, severity, frequency and period of adverse events

Secondary Outcome(s)

Increase (%) in alveolar bone height Clinical attachment level (CAL) Probing pocket depth (PD) Bleeding on probing (BOP) Gingival index (GI) Tooth mobility

Source(s) of Monetary Support

Japan Agency for Medical Research and Development

Secondary Sponsor(s)

Osaka University Hospital Medical Center for Translational Research

Ethics review

Status: YES
Approval date: 07/09/2012
Contact:

[e-mail]

Osaka University Graduate School of Dentistry / Faculty of Dentistry and Dentistry Hospital Ethics Review Committee

06-6879-2831

[e-mail]

Results

• Results available: Yes
• Date Completed: 31/03/2019