An exploratory open trial to examine the safety of transplantation of autologous adipose tissue-derived stem cells for periodontal regeneration.
- Conditions
- periodontitis
- Registration Number
- JPRN-UMIN000007698
- Lead Sponsor
- Osaka University
- Brief Summary
The autologous adipose tissue-derived stem cells(ADSC) were transplanted of into 12 patients, and the safety and effectiveness of periodontal regeneration by ADSC transplantation are currently being examined.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method